The FDA in mid-June approved a device developed by Synapse Biomedical (Oberlin, Ohio) to help paralyzed patients breathe without a traditional ventilator — the same one implanted in Christopher Reeve in 2003 which allowed him to be ventilator-free for 20 hours a day.
"If you think about where cardiac pacing was in the early 1950s and 1960s, that is where we are with pulmonary rhythm management now," Anthony Ignagni, Synapse president/CEO, told Biomedical Business & Technology.
The NeuRx DPS for ventilator-dependent spinal cord injury (SCI) patients who lack voluntary control of their diaphragms is implanted through minimally invasive laparoscopic surgery. It provides electrical stimulation to muscles and nerves that run through the diaphragm.
When stimulated by the NeuRx DPS, the diaphragm contracts, mimicking natural breathing, and allows air to fill the upper and lower parts of the lungs rather than forcing air in with a mechanical ventilator.
"Our first patient was implanted in March 2000 and has been using it ever since 24 hours a day, seven days a week," Ignagni said. "Over half of our patients can use it full time. We set a minimum bar to say it's successful at four hours of continuous use. We've implanted patients who are 27 years post-injury."
Ignagni said 140 patients have been implanted to date via clinical trials.
The FDA approval is based on studies of 50 patients implanted with the device in clinical trials at hospitals in the U.S. and Canada. All of the implanting surgeons were trained under the direction of Raymond Onders, MD, director of minimally invasive surgery at University Hospitals (Cleveland) and a founder, board member and shareholder of Synapse.
In the clinical trial, NeuRx DPS allowed 98% of SCI patients who had been dependent on mechanical ventilation via a tracheostomy with an alternative that allowed them to breathe normally and live more active lives. To date, more than half are able to completely eliminate their need for mechanical ventilation.
The NeuRx DPS is controlled via a four-channel, battery-powered external pulse generator, which negates the need for a source of electricity and the concern for power outages.
Elimination and reduction of the use of a mechanical ventilator also greatly reduces the patient's risk of complications such as ventilator acquired pneumonia, which occurs in 50% of SCI patients.
The best patient candidates are those with high-level spinal cord injury with stimulatable diaphragms, but who lack control of their diaphragm, resulting in the need for mechanical ventilation. The majority of these eligible patients have been hurt through motor vehicle accidents and sports injuries.
During outpatient surgery, four dime-size holes are created in the abdominal region. The surgeon then inserts a laparoscope so that the diaphragm muscle can be seen. Small electrodes are placed within the diaphragm and attached through wires under the skin to a small external battery-powered pulse generator that stimulates contraction of the diaphragm muscle, allowing the patient to breathe.
Patients need a short rehabilitation period so that their weakened diaphragms can be strengthened, gradually allowing increasing amounts of time off the ventilator. Over time, many are able to free themselves completely from the ventilator.
The NeuRx DPS was developed over the course of 20 years through a joint effort of physicians and engineers at several institutions, including University Hospitals Case Medical Center, Case Western Reserve University and the Veterans Affairs Medical Center.
Elsewhere in the product pipeline:
• A.D.A.M (Atlanta) reported the introduction of the A.D.A.M. symptom navigator web application for the iPhone. This interactive tool helps consumers match medical symptoms with relevant assessments and appropriate treatments. A.D.A.M. engineered this web application version of its Symptom Navigator for optimal display on the iPhone, taking full advantage of its multi-touch interface. Using the symptom navigator, consumers are presented with an image of the human body and they click on the affected area of the body to receive a menu of related symptoms. After selecting a symptom, the user is walked through the possible causes, home care, when to consult your doctor, and what to expect from your doctor. This data is provided by A.D.A.M. from their medically reviewed, evidence-based and URAC accredited health encyclopedia.
• Aethlon Medical (San Diego) said that the Aethlon Hemopurifier has proven effective in capturing the reconstructed Spanish Flu of 1918 virus (1918rv). During in vitro testing, high concentrations of 1918rv were rapidly depleted from cell culture fluid when circulated through the Hemopurifier. The Hemopurifier also has demonstrated effectiveness in capturing H5N1 avian influenza (bird flu). The Hemopurifier is a broad-spectrum therapeutic device able to separate and then capture circulating viruses by glycoproteins that reside on their surface. In the case of pandemic influenza, the Hemopurifier is able to separate and then capture circulating influenza virus by hemagglutinin (HA) and neuraminidase (NA) glycoproteins that reside on the virus surface regardless of mutation. Aethlon Medical specializes in products to treat infectious disease.
• AgaMatrix (Salem, New Hampshire) reported the launch of the WaveSense presto and WaveSense KeyNote Pro blood glucose monitoring systems (BGMS). The Presto is a no-code meter that consumers can buy at a value price. The Pro is designed for use in institutional settings. The Presto has all the features of AgaMatrix's first product, the WaveSense KeyNote, but does not require coding and is priced considerably less than no-code products from the major brands, accrding to the company. The system also has improved ergonomics and a brighter backlit display. Like the KeyNote, it requires a small sample size (0.5 microliters) and has alternate-site testing. AgaMatrix makes diabetes care products.
• Agilent Technologies (Santa Clara, California) has introduced the latest version of its Agilent DNA microarray scanner, using SureScan high resolution technology to deliver high resolution and rapid scan times for current and next-generation microarrays. The new scanner offers resolutions of 10 microns, 5 microns, 3 microns and 2 microns, and the instrument can scan a 244,000 feature microarray at the maximum resolution in about 20 minutes. Agilent Technologies is a measurement company and a technology leader in communications, electronics, life sciences and chemical analysis.
• Alma Lasers (Las Vegas) reported FDA clearance for the Harmony, its newest platform for multiple aesthetic laser and light treatments. The Harmony can be used to treat more than 60 popular aesthetic indications and applications, including acne, skin rejuvenation, hair removal, varicose veins, stretch marks, tattoo removal, wrinkles and skin tightening. The Harmony combines lasers, pulsed light, near-infrared, LED and UVB technologies with multiple exchangeable handpieces to ensure easy and effective singular and combined therapeutic treatment. Alma Lasers makes laser, light, and radiofrequency based aesthetic devices.
• American Bio Medica (ABMC; Kinderhook, New York) said that the FDA has granted clearance on its rapid TOX cup, a patent-pending drug screen in an all-inclusive cup platform. The clearance allows ABMC to provide the rapid TOX cup to customers in clinical markets. ABMC CEO Stan Cipkowski said: "The rapid TOX cup has already been well received in the criminal justice market as it provides accurate results in an easy-to-use format, all at a lower cost to the customer. This clearance opens up additional markets to ABMC and also allows us to market the product to those customers that want a FDA-cleared productThe rapid TOX cup is an accurate drug screen. The rapid TOX cup doesn't require any manipulation of the device; the donor voids into the cup. Its wide mouth and larger cup allow for easier specimen collection. A temperature strip is affixed to the cup to ensure specimen integrity, with the option to add a specimen validity test strip.
• AngioScore (Fremont, California) reported the start of enrollment in the AngioSculpt scoring balloon catheter multi-center coronary bifurcation study, or AGILITY trial. The AGILITY trial will enroll 100 patients with coronary bifurcation lesions at eight premier interventional cardiology programs in the U.S. and follow these patients for nine months. AngioScore says the AngioSculpt scoring balloon catheters represent the next generation in angioplasty catheters for both coronary and peripheral artery disease. Their nitinol elements provide circumferential scoring of plaque, leading to precise and predictable luminal enlargement across a wide range of lesion types while avoiding "geographic miss" through their unique anti-slippage properties. AngioScore makes angioplasty catheters for treatment of cardiovascular disease.
• Applied Biosystems (Foster City, California) and its joint-venture partner, MDS Analytical Technologies, a business unit of MDS, reported the availability of a suite of integrated mass spectrometry-based solutions for conducting targeted quantitative proteomics studies. Designed for Applied Biosystems/MDS Analytical Technologies' triple quadrupole and hybrid triple quadrupole/linear ion trap mass spectrometry systems, these solutions include software packages and consumables that help scientists to quantify proteins in biomarker research or cell biology. Through a joint venture with MDS Analytical Technologies, Applied Biosystems makes products for the mass spectrometry market, based on industry-leading platforms, software and new application workflows.
• Artes Medical (San Diego), a medical aesthetics company that makes ArteFill, a non-resorbable injectable dermal filler for the correction of nasolabial fold or "smile line" wrinkles, reported the publication of data comparing polymethylmethacrylate (PMMA) based soft tissue fillers in the June issue of Dermatologic Surgery, a publication of the American Society for Dermatologic Surgery. ArteFill is a dual-acting aesthetic injectable implant. ArteFill consists of a combination of PMMA microspheres suspended in a carrier gel containing highly purified bovine collagen with 0.3% lidocaine. Following injection, the PMMA microspheres, which are 30 to 50 microns in diameter and barely visible to the naked eye, reside at the injection site for persistent wrinkle correction. The company believes that the uniformity of size, shape and surface area of each microsphere, taken together with manufacturing consistency, plays an important role in the safety and efficacy of PMMA-based products.
• Axiom Worldwide (Tampa, Florida) reported the introduction of the DRX9000 true non-surgical spinal decompression system — designed to provide a non-invasive option for discogenic low back pain. Axiom also manufactures a digital electroceutical device, the EPS8000, for use in relieving pain and for use in muscular rehabilitation. Axiom makes non-surgical alternatives to spinal surgery.
• Bayer Diabetes Care (Tarrytown, New York) unveiled at the annual meeting of the American Diabetes Association in San Francisco its new Contour blood glucose meter with enhanced testing features that can be personalized to best meet patients' individual treatment needs. In addition to the new meter, Bayer introduced a redesigned Microlet2 lancing system and new product packaging. In addition to Bayer's No Coding technology, small sample size and fast testing time, the company said the updated Contour is "the only meter that offers patients the flexibility to choose either 'Basic' or 'Advanced' levels of testing, to keep the management of their diabetes as simple and specific as they would like." The new, personalized features include programmable testing reminders and pre- and post-meal markers that provide information on how a meal can affect blood glucose, a feature particularly helpful for self-adjusting insulin users. The advanced settings also allow users to set their own high and low blood glucose targets to fit their management needs and provide personal 7-, 14- and 30-day testing averages.
• Biopure (Cambridge, Massachusetts) said that the results from its Phase III orthopedic trial (HEM-115) have been published in the June issue of the Journal of Trauma. The paper is titled "HBOC-201 as an Alternative to Blood Transfusion: Efficacy and Safety Evaluation in a Multicenter Phase III Trial in Elective Orthopedic Surgery." The paper's authors concluded that HBOC-201 eliminated the need for transfusion in the majority of patients. Patients less than 80 years of age with moderate clinical needs safely avoided transfusions when treated with up to 10 units of HBOC-201. The intent-to-treat analysis was unfavorable, with the crossover group (HBOC-201 to PRBC) being identified as the primary basis for the difference. The analytical methodology used identified that the crossover patients had a greater need for an oxygen carrier, likely related to patient age, volume overload and under-treatment. Biopure makes oxygen therapeutics.
• biospace med (Atlanta) reported that New Jersey Spine Group (Eatontown, New Jersey) is the first healthcare facility in the U.S. to install the company's EOS X-ray imager-an ultra-low-dose x-ray technology. EOS can capture head-to-toe images of patients in a standing, weight-bearing position with a reduction in radiation dose-up to 10 times less than a conventional x-ray and up to 1000 times less than a CTscan. biospace med is a total solution in orthopedic imaging company.
• Biotronik (Berlin, Germany) reported the launch of the Lumax 540 series, which includes implantable cardioverter defibrillators (ICDs) and a cardiac resynchronization therapy defibrillator (CRT-D). Together with Biotronik Home Monitoring, this enables continuous automatic daily data transmission of the patient's cardiovascular status. The information is available to the physicians online allowing them to continuously check their patients' cardiac and device status. The Lumax 540 devices offer the combination of advanced tachycardia therapy management, diagnostic capabilities and remote monitoring technologies that support physicians in creating efficient care pathways for their patients with cardiac devices and further improve patient care. Biotronik makes wireless monitoring technology.
• Braemar (Minneapolis) has introduced the DL900, a digital Holter monitor. The monitor weighs 1.75 ounces, and has extended recording time of up to seven days. A newly designed, custom analog IC for signal acquisition is the technology platform for the advanced capabilities of the DL900. The device combines high-speed USB transfer capability with the ability to use a removable SD memory card. The DL900 provides high-resolution recordings as well as high sampling rate options suitable for both clinical and research applications. A programmable pacemaker detection capability provides the clinician with additional data. Braemar makes cardiac monitoring devices.
• Calypte Biomedical (Lake Oswego, Oregon) reported the launch of Calypte Life Sciences. Calypte Life Sciences offers a broad range of recombinant proteins and antigens, as well as proprietary reagents, buffers and other specialty products to researchers and institutions seeking to develop and optimize immunodiagnostic assay systems. Calypte makes HIV diagnostic tests.
• Cardiac Science (Bothell, Washington) said it has completed certification for its HeartCentrix ECG informatics software with the Allscripts Electronic Health Record (EHR). The connectivity between Cardiac Science's equipment and the Allscripts EHR will help physicians streamline the diagnostic cardiology workflow in their offices, eliminate a source of data transcription errors, and provide a unified view of patient diagnostic data. With HeartCentrix ECG informatics, physicians will have immediate access to view or edit a patient's test results electronically and later retrieve the data from the Electronic Health Record. Cardiac Science makes resuscitation, rehabilitation and informatics products.
• Cardinal Health (Dublin, Ohio) has launched a new system that leverages its dispensing technologies to enable clinicians access to a patient's medications and medical supplies from one system. The Pyxis DuoStation system helps clinicians to safely and accurately dispense both medications and medical supplies from a single dispensing machine. The new automated dispensing system is built on the foundation of the Pyxis MedStation system and Pyxis SupplyStation system. The DuoStation functions similarly to Cardinal Health's existing dispensing technologies. Nurses use unique identifiers, such as an employee ID number and their fingerprint, to log onto the system. After log-in, a screen appears and the nurse selects a patient and sees a list of medication orders that have already been verified by one of the hospital pharmacists. Additionally, the nurse can toggle to a medical supplies screen and select the supplies needed to care for the patient. In addition to the safety benefits of dispensing the right medications for the right patient, the system records the medications and supplies used for each patient and then transfers the information to the hospital's billing system.
• Technology transfer firm Competitive Technologies (CTT; Fairfield, Connecticut) said it will display a pain management therapy device at this week's BIO International Convention in San Diego. CTT has exclusive worldwide distribution rights to the pain therapy device, a non-invasive method for rapid treatment of high-intensity oncologic and neuropathic pain, including pain resistant to morphine and other drugs. The device, which uses a multi-processor able to simultaneously treat multiple pain areas by applying surface electrodes to the skin, has CE-mark certification, allowing European sales, and CTT said it has applied for FDA 510(k) authorization. The device was developed in Italy by Giuseppe Marineo, DSc, MD. CTT South Korean partner GEOMC, formerly Daeyang E&C, is producing the device commercially for worldwide distribution.
• The registry arm of a clinical study measuring the effectiveness of Cook Medical's (Spencer, Indiana) Zilver PTX drug-eluting peripheral stent (DES) in treating peripheral arterial disease (PAD) has yielded positive interim results. "Cook's registry study and randomized trial are the first to use a paclitaxel-coated stent in the treatment of arterial blockages outside the heart," said Michael Dake, MD, professor of radiology, internal medicine and surgery at the University of Virginia Health System, and the trial's principal investigator. "They are designed to evaluate the safety and effectiveness of DES technology vs. percutaneous transluminal angioplasty, and our initial findings in the registry arm give us every reason to believe that Zilver PTX has the integrity, safety and durability needed to successfully address many of the well-known limitations of angioplasty alone for management of PAD." Cook Medical specializes in interventional medicine products.
• Cook Medical (Bloomington, Indiana) reported the first human use of its Zenith low-profile AAA endograft system. The Zenith Low Profile AAA Endograft System addresses those areas of concern by reducing the size of the delivery sheath to 16 Fr. This development, if proven safe and effective in an upcoming clinical trial, could open endovascular treatment of aneurysms to a new class of patients who currently have only open surgery as a treatment option due to the small diameter of their blood vessels and other anatomic issues. In addition, it may enable physicians to eliminate the need for a surgical cut down to access the femoral artery and allow the use of the percutaneous entry technique where a needle is inserted to allow the guidewire and delivery sheath to enter the artery with far less trauma. Cook Medical makes products to treat diseases of the aorta.
• Covidien (Boulder, Colorado) said that two new continuous positive airway pressure (CPAP) devices, the Sandman Info and the Sandman Auto, are now available in the U.S. They are the latest additions to the company's Sandman portfolio of sleep diagnostic and therapy devices that feature integrated heated humidification and adaptive pressure stability technology. The Sandman devices include integrated heated humidification which minimizes tubing condensation, thus decreasing air resistance in the tube and preventing water droplets from flowing back into the patient's mask. Sandman CPAPs will automatically remind patients to perform routine service and change disposable parts. Ergonomic and aesthetic enhancements include forward-facing controls and a backlit display. Covidien makes product lines in four segments: medical devices, imaging solutions, pharmaceutical products and medical supplies.
• CryoCath Technologies (Montreal) reported the introduction of Arctic Front in Hong Kong. Arctic Front, the company's lead product for the treatment of paroxysmal atrial fibrillation (PAF), is a cryoablation balloon catheter that allows physicians to isolate all four pulmonary veins in the treatment of PAF. Arctic Front is a minimally invasive bi-directional, double-ballon cryo-balloon catheter designed specifically to treat PAF. CryoCath makes cryotherapy products to treat cardiac arrhythmias.
• Delcath Systems (New York) said St. Luke's Cancer Center (Bethlehem, Pennsylvania), has joined Delcath's Phase III clinical trial for the treatment of inoperable metastatic melanoma in the liver, a multi-center study led by the National Cancer Institute and involving cancer centers throughout the U.S. The study is designed to test Delcath's PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver. The PHP System is designed to deliver significantly higher doses of anti-cancer drugs to a patient's liver while preventing entry of the drugs to the rest of the patient's circulation. This isolation limits toxicities that result from systemic chemotherapy treatments. Delcath Systems is a development-stage company testing its percutaneous perfusion technology for the isolated delivery of high doses of therapeutic and chemotherapeutic agents.
• DePuy Spine (Raynham, Massachusetts), a Johnson & Johnson company, reported the worldwide launch of the Confidence Spinal Cement System, a treatment for vertebral compression fractures, a condition that occurs when one or more vertebrae collapse, usually as a result of osteoporosis. The Confidence consists of a proprietary hydraulic-based delivery system that provides precise placement of a specially formulated high viscosity polymethylmethacrylate bone cement directly into vertebral bodies to stabilize fractures and to potentially reduce pain. DePuy Spine treats spinal orders.
• DPS (Los Angeles) said that its virtual lifestyle management service (VLM) is now available for licensing by healthcare providers through Microsoft HealthVault, Microsoft's consumer health platform. DPS software allows clinicians to provide their patients with an internet-based weight management system that features online lessons, workbooks, and behavioral tracking supported by email coaching to help people become more active, eat better, lose weight and live healthier lives. DPS makes software on research-proven lifestyle coaching methods.
• Draeger Medical (Telford, Pennsylvania) said that it has received FDA clearance to market the Carina, its latest product in its ventilator product line for the U.S. market. The Carina offers both invasive and non-invasive capabilities in one device. Its latest technology, known as "Synch Plus," will compensate for leakage and provide effective breath delivery. The Carina is well-suited for the emergency room, general ward, ICU, or sub-acute facilities as it features an internal battery and can operate independent of a high-pressure gas system. Draeger Medical, the U.S. unit of Draeger Medical AG, is a leader in mechanical ventilation.
• Dynamics Research's (New York) metrigraphics division reported the introduction of micro-induction coils designed for use in implanted medical applications and traditional biomedical devices. The micro-induction coils are equipped with radio frequency signal transmission and signal and power induction capabilities, thereby eliminating the potential harmful effects to the human body posed by battery-operated implantable medical devices. Metrigraphics' new family of coils is classified by two groups single- and multiple-layer forms. Single layer multiple-turn electroformed coils are available in round and square configurations. Multi-layer coils offer greater field density for more high-end applications. Dynamic Research specializes in fabrication of customized micro-components and micro-circuits.
• EuroMed (Northvale, New Jersey) has added a new product to its SureSkin line of hydrocolloid dressings, launching what it called "a new offensive against chronic and acute wounds." The new product is called SureSkin III Silver because it is constructed with silver ions that serve as antimicrobial agents throughout the entire wear time of the dressing. The silver ions in the SurSkin III Silver dressing attack bacteria by way of their cell walls. The dead bacteria are then absorbed into the wound dressing gel and are removed when the dressing is changed, along with moderate levels of wound exudates. Hydrocolloid dressings create a moist wound environment that facilitates the healing process. EuroMed makes wound-care management products.
• GE Healthcare (Waukesha, Wisconsin) said it would be showcasing the company's new single photon emission computed tomography (SPECT) imaging applications, positron emission tomography/ computed tomography (PET/CT) MotionFree technologies, and new pre-clinical imaging and radiopharmaceutical offerings at the annual meeting of the Society of Nuclear Medicine, which began Sunday in New Orleans. Rounding out GE Healthcare's presence is an Innovation Center that will showcase future generation imaging technologies. GE is launching two "breakthrough" software packages on the company's flagship 4-slice SPECT/CT, the Infinia Hawkeye 4. The new Volumetrix Suite consists of two applications that deliver image clarity and diagnostic confidence with precise detection and localization of disease, the Volumetrix 3D and Volumetrix IR. Volumetrix 3D brings together the convenience of advanced 3-D visualization with the productivity and ease of traditional 2-D image analysis. Volumetrix IR offers a clinician the choice of virtually any CT to view registered to the SPECT data, all within the nuclear medicine workflow. Highlighting GE's PET/CT presence at SNM 2008 is the Discovery platform, optimized for advanced clinical applications. The Discovery series of PET/CT scanners feature what GE terms "industry-leading sensitivity" and VUE Point HD high-definition imaging, with improved signal-to-noise ratio (SNR) for all PET/CT exams.
• GlycoMark (New York) reported results from the ongoing DURABLE clinical trial showing that the GlycoMark blood test is a better reflection of glucose, particularly after-meal glucose levels, than the gold standard hemoglobin A1C test in moderately controlled patients with diabetes. In the study, the 1,5-Anhydroglucitol blood test (GlycoMark) correlated more strongly than hemoglobin A1C with all self-monitored plasma glucose (SMPG) parameters, particularly after-meal glucose levels, in moderately controlled patients with A1C levels less than 8.0%. GlycoMark is an FDA-approved test for monitoring intermediate glycemic control by measuring the levels of a monosaccharide 1,5-anhydroglucitol (1,5- AG) in blood. GlycoMark is being used in clinical practices nationwide and is available at major reference laboratories.
• HoMedics (Commerce Township, Michigan) reported that its Thera-P Blood Pressure Monitors are compatible with Microsoft HealthVault, a free Web-based platform designed to put consumers in control of their health data. HoMedics blood pressure units, with HealthVault, incorporate features including DK Technology, which uses a built-in microphone to listen to the body to take an accurate reading. HoMedics makes personal healthcare and wellness products.
• ikaSystems (Southborough, Massachusetts) has released a new offering for the Medicare market. ikaMedicareGateway allows payers to expedite and increase the accuracy of Medicare application processing, eligibility verification, and enrollment, membership and payment reconciliation through online functionality and real-time access to information from CMS' MARx database. The process begins with an online application portal, which members, brokers or administrative staff can use to start the enrollment cycle. Through ikaMedicareGateway, instant eligibility queries and beneficiary look-ups are performed against the MARx database. Responses are immediate, both ensuring the accuracy of the information supplied and pulling data from the database to populate the rest of the application, saving time for administrative staff. ikaSystems makes web-based technologies for healthcare payer organizations.
• Imtec (Los Alamos, New Mexico) introduced the SPRITE, a small-footprint CT system. The system uses touch-screen technology as its user Interface, and an advanced 4-stage rotary system to simplify and ensure successful scanning setup and execution. The SPRITE also offers rollers for ease of movement and dimensions small enough to allow passage through any conventional doorway. Imtec's primary focus is on dental applications and the development of new technology to simplify dentistry.
• Isotechnika (Edmonton, Alberta) said that voclosporin is positioned to enter a Phase 1 clinical trial as the drug used in the Cinatra drug-coated coronary stent system developed by the company's partner, Atrium Medical. The Cinatra voclosporin coated coronary stent system is made of a cobalt chromium bare metal stent mounted on a delivery balloon catheter. The stent and the balloon are coated with Atrium's Omega-3 fatty acid coating technology, using voclosporin for its anti-inflammatory properties. Isotechnika is an international biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments. Atrium makes technologies for the treatment of cardiovascular disease, hernia and adhesion prevention.
• Lantheus Medical Imaging (North Billerica, Massachusetts) presented Phase I data relating to the safety and tolerability in human subjects of BMS747158, its fluorine 18-labeled Positron Emission Tomography (PET) tracer for myocardial perfusion imaging. The preliminary clinical findings indicate that when used with PET technology, BMS747158 demonstrates a favorable radiation dosimetry profile and is generally well-tolerated. The Phase I clinical trial was designed to estimate radiation dosimetry of a single-dose of BMS747158 in healthy subjects at rest. Secondary objectives included assessing human safety, tolerability and biodistribution. Thirteen subjects were injected with 150-260 MBq of BMS747158 intravenously at UCLA Medical Center. Whole body imaging using PET technology was conducted for five hours to collect data for radiation dosimetry calculation. Extensive safety monitoring was conducted with clinical labs, ECG, EEG, neurological, heart rate and blood pressure assessment at several time points during the study. Lantheus specializes in diagnostic imaging.
• LDR (Austin, Texas) said it has begun to market its ROI-T partial vertebral body replacement device following recent FDA clearance. The ROI-T is a transforaminal approach implant with an anatomic shape that conforms to the anterior vertebral body, the minimal width and tapered end of the device facilitating insertion through a small opening. The open interior cavity allows for substantial graft amounts. The ROI-T is made of PEEK-Optima for biocompatibility and radiolucency along with Tantalum markers for verification of implant positioning. The system is made of multiple lordotic angles and heights for optimized fit per anatomical requirements. LDR is a spine solutions company.
• Lutronic (Princeton Junction, New Jersey) said that it has received FDA clearance to market its Spectra VRM III. This dual-pulse, Q-Switched Nd:Yag laser is the successor to the Spectra VRM II. The laser produces 4 wavelengths (1064 nm, 532 nm, 585 nm, 650 nm) in Q-switched nanosecond pulse. It is specifically designed to treat a wide array of dermatological and aesthetic conditions, including dermal and epidermal pigmented lesions, multicolor tattoos, melasma, and active acne. It further enables laser toning, and non-ablative photo-acoustic skin rejuvenation techniques.The laser uses a dual pulse mode, which enables it to produce very short and quasi-long microsecond pulses. Lutronic makes medical laser systems.
• Medical Headway (Houston) reported the launch of an online medical-breakthrough library, MedicalHeadway.com, aimed at providing the public with news of the latest breakthroughs in the world of medicine. Medical Headway said its partnerships with private researchers, physicians, surgeons, scientists, device manufacturers, medical centers and other entities has enabled it to find a niche as a source for those seeking comprehensive information about medical breakthroughs.
• Mentor (Santa Barbara, California) said it has taken the first steps toward entry into the U.S. neurological marketplace by completion of enrollment in the Phase I study in its U.S. investigational study of botulinum toxin type A for torticollis/ cervical dystonia. Mentor is a supplier for the global aesthetics market.
• Momentive Performance Materials (Wilton, Connecticut) has introduced the StatSil elastomer, made using a new technology that provides built-in antimicrobial protection in silicone-based elastomers. StatSil elastomer should be used only to control the growth of microbes in or on the human body; it should not be used to provide general public health benefits. Momentive Performance Materials is a specialty materials company.
• Neurotechnology (Vilnius, Lithuania) reported the addition of VeriEye iris recognition technology to the company's suite of biometric identification algorithms and software development products. VeriEye SDK features iris recognition algorithm that rapidly detects and compensates for partial obstructions, irregularities and deformations in the iris shape — even when the eyes are gazing away. This provides a high degree of accuracy that can make VeriEye suitable for use in a wide range of applications for security, access control, time and attendance and other systems that require fast and reliable identification. The new iris matching algorithm in VeriEye rapidly compares two sets of iris features and is similarly capable of detecting and compensating for obstructions on iris texture and in deformed "looking away" iris images. Matching speeds against existing iris records can range from 50,000 to 150,000 irises per second, depending on configuration. Neurotechnology makes biometric fingerprint, face and iris identification algorithms, object recognition technology and software development products.
• Nephros (New York) said it has completed the U.S. clinical trial for its OLpur H2H module and OLpur MD220 filter for end stage renal disease (ESRD) therapy. The Nephros line of water-filtration products incorporates its patented cold sterilization filtration technology, the Dual Stage Ultrafilter (DSU). The DSU has the capability to filter out bacteria, parasites, viruses and other biotoxins to produce biologically safe water, and its dual-stage design reduces the risk and facilitates detection of filter failure. With initial applications targeted at infection-control and potable water solutions, the DSU is in a pilot-use program at a U.S. medical center and has been selected for further development by the U.S. Marine Corps. Nephros makes products for ESRD therapy and water ultrafiltration.
• Omnicell (Seattle) reported general availability of both its SinglePointe automated patient-specific management solution and Omnicell 12.0 automated dispensing software. Both solutions have been successfully implemented at a number of healthcare facilities to help pharmacists and nurses to reduce the risk of medication errors and increase staff efficiency. Randall Lipps, chairman/president/CEO of Omnicell, said, "The SinglePointe solution represents a major leap forward in medication management by providing a single point of access and a way to store, manage and track patient-specific medications. We have also incorporated many new features in Omnicell 12.0 that were inspired by feedback from our customers and designed to help medical staff to reduce medications errors." Omnicell makes products for acute healthcare facilities.
• A new study indicates that the OtisKnee custom fit knee replacement system, made by OtisMed (Hayward, California), may have a positive impact on length of hospital stay, range of motion, pain level and patient satisfaction immediately following total knee replacement surgery. The study results also indicated that OtisKnee is useful to the surgeon in pre-determining ideal implant size as well as defining proper rotation and positioning during the total knee replacement procedure.
• PAL Health Technologies (Pekin, Illinois) reported the launch of the Xtremityscan system, a digital shape acquisition system that allows doctors of podiatary medicine and other practitioners to acquire three-dimensional foot shapes in mere seconds, without the messy, time-consuming plaster casting process formerly used to obtain the same information. The Xtremityscan system is available in two models — a mobile cart-based scanning system that operates wirelessly and can move between treatment rooms, and a portable model that can travel among multiple offices. Specially-designed software captures an image of the plantar surface of the foot. Advanced imaging software then creates a three-dimensional model of the image. Scans take only seconds to complete, then resulting images can be rotated 360 degrees and displayed in wireframe, surface and topographical views. PAL offers a full line of custom foot orthotics through the Xtremityscan system.
• Perceptive Informatics (Boston), the technology subsidiary of Parexel International, said that it has integrated its medical imaging technology with the functionality of DigiView, a specialized image management and reporting system provided by Digisonics, to offer clients expanded capabilities for cardiac function assessment in clinical studies. The system provides electronic review, analysis, reporting, and archiving of medical images related to cardiac function assessment. Cardiac function assessment is required for a broad range of therapeutic area research, including cardiology, oncology, central nervous system, and metabolism/endocrinology studies. Parexel said its technology division, Perceptive Informatics, combines clinical knowledge, quality and regulatory experience with advanced technology to decrease time to market, risk and cost associated with clinical trials.
• The Premier (Charlotte, North Carolina) healthcare alliance reported the release of "significant enhancements" to SupplyFocus, which it called "the industry's supply chain benchmarking tool." SupplyFocus' IDN-, facility- and department-level reports tap into the industry's largest comparative database of operational and supply chain cost information and feature quarterly updates focused on financial and supply cost metrics. In addition, SupplyFocus includes supplier data, allowing for analysis of contract pricing and penetration. Data analysis is enhanced by extensive custom peer grouping capability, allowing users to create an unlimited number of peer groups and benchmarks employing demographic information as well as performance metrics. Premier is a healthcare purchasing network.
• Respironics (Murrysville, Pennsylvania) reported the release of the Alice LE sleep system. The device is intended to help sleep technicians use the most appropriate system when performing routine polysomnogram studies. It has 31 channels and is the size of the current Respironics Alice 5 sleep system. The Alice LE runs on the Sleepware software program that is designed to monitor, display, process and download polysomnographic data. Respironics makes products for the sleep and respiratory markets.
• Rosetta Genomics (Rehovot, Israel) reported the advancement of three new diagnostic tests into its development pipeline. Leveraging microRNA biomarkers identified using Rosetta Genomics' microRNA extraction and quantification methods, the new programs will focus on the following indications: predicting response to treatment of ovarian cancer patients; predicting risk of gastric cancer recurrence; differentiating small from non-small cell lung cancer.
• Sequenom (San Diego) reported positive results from screening studies using the company's noninvasive circulating cell-free fetal (ccff) nucleic acid SEQureDx technology, which enables the detection of fetal aneuploidy, including Down syndrome from maternal blood. Sequenom's SEQureDx technology is a novel approach to genetic screening. Unlike current standards of harvesting placental tissue cells as is required for chorionic villus, or entering the uterus to sample the amniotic fluid surrounding the baby as is performed with amniocentesis, SEQureDx extracts fetal nucleic acid material safely and comfortably from a simple blood specimen collected from the mother to determine the genetic status of the fetus. This suggests that effective screening may be accomplished in the future without the risks associated with disturbing the amniotic fluid that surrounds the baby in the uterus. Sequenom makes genetic-analysis products for research and the molecular diagnostics market.
• Simbionix (Cleveland) reported the release of a module for its LAP Mentor simulator that gives trainees hands-on experience with different techniques and alternative approaches to the treatment of ectopic pregnancy, tubal sterilization and oophorectomy. The GYN module is the latest addition to the suite of laparoscopic procedures developed for the LAP Mentor, which the company calls "the world's most advanced laparoscopic surgery simulator." The GYN module makes use of the LAP Mentor's 3-D real-life graphics and ergonomically designed hardware to provide the most realistic experience of training and learning possible. The module includes an expandable library of virtual patients with a variety of anatomical anomalies and complications, a complete set of laparoscopic instruments including those unique to GYN procedures, exceptional audio and visual learning aids and a comprehensive set of performance metrics. Simbionix makes medical simulation products.
• Soquel Group (Monterey, California) has introduced a new tool, the Shark Tooth Starter Broach, for performing minimally invasive hip replacement surgery. Measuring approximately 6 cm in length, the Shark Tooth is a much smaller broach than currently available in the toolkits provided with hip replacement systems. The Shark Tooth helps surgeons to more easily prepare the femur for joint implants through a smaller incision. The design of the new broach allows proper orientation of the broach when limited by the constraints of the anatomy of the anterior approach or when spatial constraints pose a problem. The design of the Shark Tooth is especially useful when using the anterior approach for hip arthroplasty where confined space may pose a problem for the surgeon when using standard broaches. Its compact and curved shape is markedly different than previously available broaches. Soquel Group provides strategic services to innovative technology companies including patent drafting, prosecution, and commercialization.
• Spartan Bioscience (Ottawa, Ontario) reported a "significant breakthrough" for its Spartan DX DNA analyzer. The addition of a second (Red) channel for optical detection permits scientists to test for two genetic markers simultaneously in the same reaction tube. It also enables scientists to run internal controls to confirm that an assay is working properly. This product enhancement could provide improved diagnostic capabilities for their on-demand DNA testing applications, including real-time polymerase chain reaction. Scientists have validated the Spartan DX for applications such as on-demand testing for herpes simplex virus (HSV) in pediatric meningitis, and testing for vancomycin-resistant Enterococci (VRE), an antibiotic-resistant "superbug." Spartan Bioscience makes DNA analyzers for on-demand applications.
• Standing Stone (Westport, Connecticut) reported the launch of its DMClinic software application. DMClinic features detailed checklists on Health Maintenance Activities, tracking of multiple diabetes medications, comprehensive patient and clinic reports and a patient education section all combined with Standing Stone's "one screen" approach which helps speed data input and clinic efficiency. Installing DMClinic's HL7 interface enables automatic synchronization of data throughout the organization. "Our customers have been asking for a diabetes management tool for several years and we are pleased to be able to offer a world class product that is an excellent adjunct to our anticoagulation and cholesterol management products," said Albert Bartosic, president of Standing Stone. Standing Stone makes disease state management solutions.
• Suni Medical Imaging (San Jose, California) reported the introduction of the SuniRay, which it called "the most advanced intraoral digital radiography system on the market." Using the latest CMOS technology and Prof Suni Advanced Imaging Software, SuniRay delivers exceptionally high image quality with maximum diagnostic capabilities, the company said.
• Sunquest Information Systems said it has provided its 510(k) premarket notification submission to the FDA for the Sunquest Transfusion Manager (TRM) software application and information system. The Sunquest TRM will integrate with Sunquest's laboratory information system and blood bank solutions, and is designed to support patient safety initiatives by reducing preventable errors from occurring during the transfusion process. TRM will be used by trained healthcare professionals responsible for transfusion services and will function primarily at the patient bedside through the use of a hand-held computing device or portable PC, with or without wireless communication. Sunquest Information Systems specializes in laboratory information systems.
• Syntermed (Atlanta) has released three new clinical diagnostic applications for neurologists and cardiologists benefiting individuals with dementia, temporal lobe epilepsy (TLE), and heart failure. The NeuroQ 3.0 upgrade analyzes PET brain scans to improve diagnosis of all types of dementia and track the progression of the disease. EQuAL, a new application with NeuroQ, helps determine before surgery, the likelihood a patient will be seizure-free following surgery for TLE. SyncTool, the newest diagnostic tool in the Emory Cardiac Toolbox, analyzes the benefits of cardiac resynchronization therapy (CRT) in heart failure patients. Syntermed is a nuclear medicine imaging and informatics software company. Syntermed is a nuclear medicine imaging and informatics software company.
• Tethys Bioscience (San Francisco) said that it has expanded the availability of its PreDx diabetes risk test, a predictive tool that delivers an accurate assessment of an individual's risk of developing Type 2 diabetes within the next five years. The new blood test is designed to help physicians identify patients at highest risk of developing Type 2 diabetes so that they can promote lifestyle changes or initiate treatment plans to prevent or slow progression to Type 2 diabetes. Tethys identified specific proteins and other biomarkers that are most predictive of a person's progression to Type 2 diabetes. Through comprehensive analysis of proteins and integration of multiple risk-defining biomarkers, the company developed a sophisticated test capable of stratifying at-risk individuals. Tethys Bioscience makes tests for chronic diseases such as diabetes.
• ThermoGenesis (Rancho Cordova, California) said it has submitted a 510(k) pre-market notification application to the FDA requesting regulatory clearance for its MarrowXpress , a device designed for the processing of bone marrow in a laboratory setting. The device is a derivative of the company's AutoXpress platform that is used to volume reduce and collect stem cells from umbilical cord blood. ThermoGenesis makes automated blood-processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products.
• Veridex (Raritan, New Jersey) said that its licensing collaborator, Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina), has launched a new gene methylation test for prostate cancer. The new assay uses the biological specificity of "DNA methylation" in prostate cancer, detecting the methylation of the gene GST-Pi. Methylation is a modification of DNA that occurs primarily in cancer. Veridex is making the methylation markers in this tissue assay, GST-Pi, along with other markers, for a urine-based screening test for prostate cancer. Veridex makes cancer diagnostic products.
• ViraCor Laboratories (Kansas City, Missouri) reported the launch of a new enterovirus test that quickly pinpoints the virus. The molecular test quickly and accurately detects the more than 70 known strains of enterovirus, giving physicians the information they need to treat patients appropriately. It also allows them to determine and track the severity of an infection by measuring a patient's viral load. The enterovirus test is one of 21 infectious disease tests ViraCor provides to healthcare professionals who care for patients with compromised immune systems, including adults and children who are undergoing transplants or battling cancer.
• W.L. Gore & Associates (Flagstaff, Arizona) said that patient enrollment has begun in a study titled, "Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses." The primary purpose of this prospective, randomized multi-center study is to evaluate and compare the outcomes of high risk colorectal or coloanal anastomoses constructed with Gore Seamguard bioabsorbable staple line reinforcement for circular surgical staplers to standard non-reinforced colorectal and coloanal techniques with respect to the incidence of post-operative anastomotic leakage, anastomotic stricture and time to ileostomy closure. Seamguard reinforcement is thinner than other reinforcement materials and is completely absorbed within six months, eliminating the risk of erosion into adjacent tissue. Gore also has introduced a new configuration of Gore BIO-A Tissue Reinforcement for hiatal hernia repair. Gore BIO-A Tissue Reinforcement is a synthetic matrix material that the company said "encourages tissue generation in soft-tissue reinforcement applications. " The new configuration is custom-shaped with a thinner design to provide surgeons with what Gore said is "a superior solution for the unique challenges faced in hiatal hernia repair. BIO-A is a web of biocompatible synthetic polymers that is gradually absorbed by the body, while its 3-D matrix of open, highly interconnected pores serves as a scaffold for tissue generation.