Arbios Systems (Waltham, Massachusetts) last month presented data from the first five patients treated with its Sepet Liver Assist Device in an ongoing feasibility trial at the annual meeting of the American Association for the Study of Liver Diseases (AASLD; Alexandria, Virginia) in Boston. The company said that while the results are still preliminary they show potential for keeping patients with chronic liver disease alive long enough to receive a transplant. With more than 17,000 people on the waiting list for a new liver, Arbios is attempting to make life on the waiting list more bearable while providing additional bridge-to-transplant time. "Patients with chronic liver disease progress toward further and further worsening over time," Walter Ogier, president/CEO of Arbios, told Biomedical Business & Technology. "They often develop liver sclerosis, or scarring of the liver, and that scarring progresses over time. They tend to be in the hospital every few weeks or months with liver problems."
While in the hospital, patients with liver disease typically receive hydration therapy — IV fluids —and antibiotics for underling infection, he said. "There aren't any really effective ways of treating these patients," Ogier said. Arbios' Sepet Liver Assist Device, a product related to dialysis, cleanses the patients' blood to help the liver regenerate itself, he said. "In patients with liver disease it is very difficult for the liver to regenerate. With our Sepet device, we're trying to remove the bad actors from the blood stream so the liver can regrow and regenerate itself."
The Sepet is a tube-like cartridge — looking much "like a standard kidney dialysis cartridge," Ogier said — containing several thousand microporous hollow fibers with unique permeability characteristics. When a patient's blood passes through the fibers, blood plasma components of specific molecular weights pass through the pores, cleansing the blood of impurities such as hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration. These substances would otherwise progressively accumulate during liver failure, causing hypotension, increasing risk of sepsis development and accelerating damage to the liver, lungs and other organs and suppressing the function and regeneration of the liver, according to Arbios.
In the study, after one or two days of treatment with Sepet, patients showed improvement in the Glasgow Coma Score and the Fischer Index, common measurements of the severity of encephalopathy, or mental confusion. Ogier also noted trends towards improvement of blood ammonia levels and MELD score, representing common measurements of the severity of liver failure. Most patients in the study were discharged from the intensive care unit within 48 hours of treatment with improvement of encephalopathy stage.
The data suggest that treatment with Sepet may provide substantial benefit to critically ill patients, Ogier said. "The results have been very encouraging, the product was well-tolerated by the patients, we observed clinical improvement in every patient. [However], these are partial results of a single-arm study."
The objective of the study is to assess the safety and tolerability of the Sepet Liver Assist Device as well as its preliminary effectiveness in reversing liver failure and resultant encephalopathy. Patients with acute-on-chronic liver failure, including encephalopathy, are eligible to participate.
Elsewhere in the product pipeline:
• Boston Scientific (Natick, Massachusetts) reported the launch of software enabling its Left Ventricular (LV) Offset feature in its Contak Renewal, Renewal 3, and Renewal 3 RF cardiac resynchronization therapy defibrillators (CRT-D). LV Offset allows fine tune synchronization of the heart by allowing adjustment of the delay between right and left ventricular pacing, which helps physicians provide more tailored care for heart failure patients. The software will operate on the Zoom Latitude programmer and allow patients who have already been implanted with a Contak, Renewal 3 or Renewal 3 RF CRT-D to have the LV Offset feature activated. The LV Offset feature can be enabled by the Zoom Latitude programmer during a patient's routine in-clinic visit. Boston Scientific's cardiac rhythm management division said it will begin providing the software to physicians "in the coming weeks."
• Bracco Diagnostics (Princeton, New Jersey) said that the results of a clinical study comparing Isovue-370 (iopamidol injection), marketed by Bracco in the U.S., and Visipaque-320 (iodixanol injection), marketed by GE Healthcare (Waukesha, Wisconsin) in the U.S., in renally impaired patients undergoing computed tomography (IMPACT) showed no significant difference in the rate of contrast-induced nephropathy (CIN) between the two agents. The IMPACT study was the first multicenter, double-blind, randomized parallel group study designed to prospectively compare the incidence of CIN after the intravenous injection of equi-iodine doses of iopamidol-370 and iodixanol-320, in 153 patients with moderate-to-severe chronic kidney disease undergoing contrast-enhanced multi-detector computed tomography (CE-MDCT). Bracco is a provider in the diagnostic imaging space.
• Conceptus (Mountain View, California), developer of the Essure birth control procedure reported FDA approval to update the bilateral placement rate data on the Essure product labeling to 94.6%, based on the company's recent post-approval study with physicians trained to perform the procedure. The PMA supplement supports a claim of 94.6%, compared to the previously approved 86%. The company has included in this placement rate data the intentional placement in nine patients that had known tubal occlusions which is contra-indicated for Essure placement. Placement rates are thus higher when physicians follow label instructions for the insertion of the Essure device. Regarding the concomitant use of the Essure device and the Gynecare Thermachoice Uterine Balloon Therapy System endometrial ablation, the company will make certain product label changes to reflect that concomitant procedures between the Essure device and endometrial ablation technologies should not be performed due to the possible inability to complete the Essure confirmation test that determines tubal occlusion.
• Cook (Bloomington, Indiana) reported the availability of the double lumem Thal-Quick chest tube designed to improve pleural drainage. The device's 17-gauge second lumen allows for increased aspiration or infusion, as the treatment channel can be used for either additional drainage or substance infusion to permit pleural drainage. This latest version of the Thal-Quick chest tube, with a second lumen and 24 French size catheter is intended to improve ease-of-use and placement of the device, as well as patient comfort. The wire guide allows a quick and direct route to the pleural drainage site. The chest tube inserter, which is fitted to the chest tube, provides a smooth transition for insertion over the wire guide, enhancing navigation and placement of the chest tube, Cook said.
• Cook Women's Health (Spencer, Indiana), a division of Cook (Bloomington, Indiana), reported the availability of its MINC Benchtop Incubator for in vitro fertilization (IVF). The MINC is intended to provide fertility clinics and embryologists with "unprecedented" embryonic environmental control. Every time an incubator is opened by a user the embryonic environment is changed, potentially leading to chromosomal breakdowns. The MINC is a compact incubator designed to significantly reduce the amount of time embryos are exposed to disruptions in temperature and pH levels — it takes only three minutes to reach environmental homeostasis in the MINC versus nearly two hours in other incubators available. Cook makes minimally invasive medical device technology for diagnostic and therapeutic procedures.
Cook Women's Health also introduced its Trans-cervical Pelvic Venogram, designed to diagnose Pelvic Congestion Syndrome, one of the causes of chronic pelvic pain, at the International Pelvic Pain Society (Birmingham, Alabama) annual meeting in San Antonio. The company said chronic pelvic pain affects about 15% of women ages 18-50 and has a "drastic negative impact" on the quality of life. A number of causes can be the source of pelvic pain, including endometriosis, interstitial cystitis or pelvic injury. The challenge for physicians has always been to diagnose the correct source of the pain.
• Carl Zeiss Meditec (Dublin, California) highlighted its refractive laser technologies for correction of vision defects at the American Academy of Ophthalmology annual meeting, Nov. 11-14 in Las Vegas. The technologies shown included the Mel 80 Excimer Laser System, which recently received FDA clearance for vision correction eye surgery. The FDA clinical trials for the MEL 80 show that 93% of patients were corrected at three months to 20/20 or better visual acuity, and 41% were corrected to 20/12.5 or better at six months. Additionally, 85% of patients achieved within one-half of a diopter of the intended correction at three months post-operative follow-up. Carl Zeiss Meditec recently filed for 510(k) approval of its femtosecond laser system, and anticipates clearance in the second half of 2007. The company's femtosecond laser is designed to provide smooth, precise flap cutting capability.
• CoreValve (Paris) reported today it has reached 200 million cycles in its accelerated cycling protocol related to CoreValve's porcine pericardium aortic heart valve for its ReValving System for percutaneous aortic valve replacement (PAVR). CoreValve has developed a delivery system for percutaneous heart valve replacement, based on a catheter-and-self-expanding-frame approach on a beating heart, thus avoiding open-heart surgery. The CoreValve procedure can be performed in a cardiac "cath lab," similar to angioplasty and stenting, resulting in less trauma to the patient and substantial cost-savings.
• CVRx (Minneapolis) reported receiving FDA approval for a conditional investigational device exemption to begin a pivotal clinical trial to evaluate the safety and effectiveness of its Rheos baroreflex hypertension therapy system, an implantable device to treat high blood pressure. The blinded study, sponsored by the company, is a prospective, randomized, multi-center trial that will be conducted at up to 40 sites in the U.S. The study seeks to determine the safety and effectiveness of the Rheos System when used in drug-resistant hypertension patients. To be enrolled, patients need to be resistant to treatment with at least three anti-hypertension agents, including a diuretic. Their systolic blood pressure must be greater than or equal to 160 mmHg. Data from this clinical trial is intended to support the pre-market approval application for the Rheos system to the FDA. The Rheos system is intended for use in patients who cannot control their blood pressure with medications, or medication combined with lifestyle modifications. The device provides what physicians might describe as a "physiologically rational" method to reduce blood pressure, using mild electrical signals to influence the body's blood pressure regulation system, called the baroreflex.
• CytoCore (Chicago) reported that it is launching a Phase I trial for a "quick, accurate, inexpensive" screening test for endometrial and uterine cancers. The test, the InPath System, will rely on a specialized computer-guided image recognition microscope system and the new P2X7 genetic marker to identify precancerous cell changes. The P2X7 genetic marker was discovered by Dr. George Gorodeski of University Hospital Case Medical Center (Cleveland; formerly University Hospitals of Cleveland), who is leading CytoCore's effort to bring the early detection test to fruition.
• diaDexus (South San Francisco, California) reported the publication of a study showing that lipoprotein-associated phospholipase A2 (Lp-PLA2), a cardiovascular-specific inflammatory enzyme associated with unstable plaque, is a strong predictor of recurrent stroke. The report, based on the Northern Manhattan Stroke Study, appears in the Oct. 23 issue of Archives of Internal Medicine. The study followed 467 patients, diagnosed as having a first stroke, for about four years. Results showed that those with the highest levels of Lp-PLA2 had an increased risk of recurrent stroke, heart attack or vascular death, even after adjusting for factors such as age, sex, ethnicity and history of heart disease. Lp-PLA2 was measured using the diaDexus' PLAC test.
• FlowCardia (Sunnyvale, California),focused on catheter-based devices for coronary and peripheral chronic total occlusion (CTO) recanalization, reported the first patient enrolled in the Peripheral Approach To Recanalization In Occluded Totals (PATRIOT) study. PATRIOT is designed to determine the safety and efficacy of the Crosser 14 and Crosser 18 Catheters for CTO recanalization in the upper and lower legs. The Crosser system is a monorail catheter delivered over standard .014" and .018" guidewires to the site of a CTO. The CROSSER uses high-frequency vibration to cross CTOs allowing for subsequent plaque debulking, balloon angioplasty and stent placement. FlowCardia also reported an FDA 501(k) submission for the CROSSER 14 coronary platform. The data used to support the coronary submission came from FlowCardia's 19-hospital, 125-patient U.S. FACTOR (FlowCardia's Approach to Chronic Total Occlusion Recanalization) pivotal study. The FACTOR study was designed to assess the safety and efficacy of the Crosser catheter for chronically occluded coronary artery recanalization.
• GE Healthcare (Waukesha, Wisconsin) has introduced an ultrasound system in a smaller and streamlined package. The LOGIQ P5 provides the same image quality, productivity capabilities and reliability of GE's LOGIQ systems. The LOQIG P5 is the next-generation portable addition to the LOGIQ family, and includes advanced applications and mid-size maneuverability for smaller spaces. The system also includes GE's patented High Definition Speckle Reduction Imaging (HD-SRI) feature, which heightens visibility of organs and lesions with improved, high-definition contrast resolution that suppresses speckle artifact while maintaining true tissue architecture; CrossXBeam spatial compounding, which enhances tissue and border differentiation with an exclusive spatial compounding acquisition and processing technique; and 4D Imaging, which acquires three-dimensional images in real time to reveal the anatomical details with image clarity. GE Healthcare is a $15 billion unit of General Electric Company.
• Haemonetics (Braintree, Massachusetts) reported launch of its SmartSuction Solo surgical suction system in the U.S., designed to enhance the ability to clear fluids from the surgical field by providing high air flow and self-regulating suction. The company said that the SmartSuction Solo system is the first product that it will sell into the general surgery market, expanding it "from a surgical blood salvage company into a broader blood management company." The product self-regulates, freeing operator time; it stands alone, ensuring consistent vacuum and air flow levels not subject to fluctuations created by demand from other operating rooms; and, it has a small, portable footprint for minimal intrusion in the surgical suite. The system received FDA 510(k) clearance in early October 2006 and is in "customer acceptance trials" in the U.S. SmartSuction, acquired from Harvest Technologies in August of 2004, is the third system developed by Haemonetics under the SmartSuction family of products.
Hydromer (Branchburg, New Jersey) has developed an anti-thrombogenic polymer coating complex (F202) designed to minimize blood coagulation. The surface bonding capabilities of the F202 polymer, which maintains long-term non-leaching properties, "are outstanding on a wide variety of medical materials such as cardiovascular devices and stents, hemodialysis equipment and intravenous catheters," the company said. Hydromer said it will be seeking medical device manufacturers who will enter into confidentiality agreements with non-analysis restrictions, submit their device samples for trial coating and provide feedback to Hydromer.
• Impliant (Milford, Connecticut) reported it has enrolled its first patient in a trial of its two-level TOPS-on-Fusion System, a device that integrates lumbar fusion with Total Posterior Arthroplasty at two adjacent levels to treat spinal stenosis with or without facet arthrosis and spondylolisthesis. Impliant develops spine arthroplasty solutions for motion preservation.
• Kinetic Concepts (San Antonio) reported that the FDA has cleared expanded indications for use for Kinetic Concepts' V.A.C. negative pressure wound therapy system. Specifically, the FDA has cleared Kinetic Concepts to market and label the unique mechanisms of action of the V.A.C. device, including "preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and removing exudate and infectious material." The expanded indications are specific to Kinetic Concepts V.A.C. Therapy devices, which are used to treat a variety of wounds, including chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. Kinetic Concepts makes a variety of products intended to improve clinical outcomes while helping reduce the overall cost of patient care.
• MedMira (Halifax, Nova Scotia), a developer of rapid diagnostic solutions, reported FDA approval for its Reveal G3 Rapid HIV-1 Antibody Test (Reveal G3), which delivers test results in less than three minutes. This is the third generation in the Reveal line of rapid HIV tests. Reveal G3 includes the addition of MedMira's InstantGold Cap which replaces the colorimetric detection agent used to visualize results on the test cartridge. This advancement eliminates the need for reconstitution and refrigeration of the colorimetric detection agent, improving the product's overall ease-of-use.
• Maquet Critical Care (Solna, Sweden) reported the introduction of NAVA (Neurally Adjusted Ventilatory Assist) to the general public at the world's largest medical trade fair, MEDICA 2006 in Dusseldorf, Germany. Maquet Critical Care's SERVO-i ventilator with NAVA is a new approach to mechanical ventilation which allows the patient to control the ventilator with his/her respiratory center. The NAVA approach to mechanical ventilation is based on the patient's neural respiratory output. Signals from respiratory control center in the brain are transmitted through the phrenic nerve to the diaphragm, where a catheter captures the electrical activity and feeds it to the ventilator. The ventilator responds by providing the requested level of support to the patient. As the ventilator and diaphragm work with the same signal, the coupling between the two is virtually instantaneous.
• Medtronic's (Minneapolis) spinal division (Memphis, Tennessee) reported the first patient implant in an FDA-approved clinical trial designed to determine the safety and effectiveness of the DIAM Spinal Stabilization System. The DIAM System is designed for patients who have degenerative stenosis and suffer from radiating leg discomfort and moderate low back pain. Degenerative stenosis is marked by the gradual narrowing of the spinal canal, resulting in pressure on the spinal cord or nerve roots. The spinal division of Medtronic also reported that the FDA has granted it an IDE for a clinical trial to study Infuse Bone Graft in a cervical spinal fusion. The investigational device will consist of Infuse Bone Graft inside a polyetheretherketone (PEEK) polymer interbody spacer used with an anterior cervical plate as a method of facilitating spinal fusion. The Infuse Bone Graft/LT-Cage device is designed to restore degenerated disc space to its original height The goal of the trial is to evaluate whether Infuse Bone Graft is a safe and effective alternative to traditional bone grafting techniques for cervical spine fusions, the company said.
• Nanogen (San Diego), a developer of diagnostic products, said that it has been issued four patents by the U.S. Patent and Trademark Office for inventions related to diabetes and Alzheimer's disease biomarkers, the most recent patents in a series describing biomarkers associated with these diseases. U.S. Patent No. 7,125, 678, "Protein biopolymer markers predictive of type II diabetes," U.S. Patent No. 7, 097,989, "Complement C3 precursor biomarker predictive of type II diabetes," and U.S. Patent No. 7,094,549, "Fibronectin biopolymer marker indicative of insulin resistance," relate to the use of mass spectrometry and time-of-flight detection to identify biopolymers that characterize type II diabetes. These markers could potentially be used in disease risk assessment and development of therapeutic avenues, the company said. In addition, U.S. Patent No. 7,101,680 "Method for detecting the presence of monomeric brain associated human glutamine synthetase," relates to a method for detecting a biochemical marker, human glutamine synthetase, by immunoassay as a potential diagnostic for Alzheimer's disease.
• NanoSensors (Santa Clara, California), a nanotechnology development company that develops instruments and sensors to detect explosives, chemical and biological agents, reported that it has completed manufacturing the initial prototype of its planned product to detect e-coli. The product is based on the company's recently licensed nanoporous silicon-based biosensor technology to detect e-coli. The proposed sensor has been designed to consist of two core functional parts: a disposable housing unit in which the actual sensor device is mounted and a separate, external data acquisition unit. Based on this design, the sensor device transmits signals across electrical leads to the data acquisition unit, which accepts the output signal from the housing unit and converts the signal to the appropriate format to display the results. The first prototype of the disposable housing unit which holds the actual sensor device was built during October 2006, and following a series of design tests, the company believes it has a functional prototype.
• Non-Invasive Monitoring Systems (North Bay Village, Florida) reported that the U.S. Patent and Trademark Office issued Patent No. 7,111,346 on Sept. 26, titled, "Reciprocating movement platform for the external addition of pulses of the fluid channels of a subject." CEO Gary MacLeod said, "This third patent (first issued as patent 6,155,976 in 2000 and second issued as 7,090,648 in 2006) encompasses 64 claims that further protects the value of the company's flagship product (AT-101) for therapeutic and diagnostic applications that have already been published in peer-reviewed research studies as well as for future products and applications." He further announced that the company has developed the Exer-Rest, a lower cost, version of the AT-101 for utilization in the home environment. The AT-101 is not currently being sold in the U.S. pending FDA approval. A clinical trial is planned for its intended use of temporary relief of musculoskeletal pain associated with osteoarthritis of the hips.
• North American Scientific (Chatsworth, California), maker of brachytherapy sources, reported receiving 510(k) clearance from the FDA to market the high-dose rate radiation treatment design of ClearPath, its breast brachytherapy product introduced last month at the 48th Annual Meeting of the American Society of Therapeutic Radiology and Oncology (ASTRO) in Philadelphia. The company received 510(k) clearance from the FDA to market the low-dose rate system, ClearPath CR, in April. The product is designed to enhance current accelerated partial breast irradiation (APBI) treatment options, an estimated $500 million U.S. market. Brachytherapy, or internal radiation therapy, makes use of radioactive sources or seeds and has emerged as one of the most common treatments for prostate cancer.
• PARI Respiratory Equipment (Midlothian, Virginia) said that its Hydrate, a heat and humidification system that uses C-Force technology, will be unveiled at the 52nd International Respiratory Congress hosted by the American Association of Respiratory Care (Irving, Texas) Dec. 11-14 in Las Vegas. The PARI Hydrate G.33 with C-Force Technology uses a capillary force vaporizer, about the size of a large aspirin tablet and made of ceramic, to heat and humidify up to 40 L/min of gas flow. When liquid is supplied to the bottom of the disc, capillary forces lift the liquid through the disc — similar to the way water is brought to the top of a tree. Heat is then applied through the top of the disc and the water undergoes phase transition into a vapor, expands, and is released under pressure through an opening. The PARI Hydrate for high flow gas therapy will be available for distribution in February, assuming FDA clearance. PARI makes aerosol delivery systems for patients with asthma, chronic lung disease, and cystic fibrosis. Biomarkers have the potential to transform the diagnosis, treatment and monitoring of disease. But for this to happen, sensitive, low-cost, high-throughput screening systems are needed to detect and measure them.
• A start-up company, QuadraSpec (West Lafayette, Indiana), has developed a system based on compact disc technology, which it said will overcome the tremendous measurement problems that have been thrown up by proteomics. The technology involves seeding the surface of CDs with antibodies and using lasers to measure the increase in the height of the surface when/if proteins in a blood sample bind to them. The company will launch its first product — in the veterinary diagnostics market — early next year. It then plans to start a program to validate breast cancer biomarkers discovered by different research groups at the same time and said it will be able to offer tests for less than $2 each. "The technology provides a way of exploiting the chemical history in the blood," said Fred Regnier, one of the inventors. "There are more than 1 million chemically distinct features in blood, and patterns of 10 to 100 proteins can tell a huge amount about the status of health, disease onset and progression, and the efficacy of drug therapy." While using biomarkers in this way is not a new idea, the concept has not made it through to clinical practice. Regnier, a professor of chemistry at Purdue University (West Lafayette, Indiana), said there are two main reasons for this.
• Royal Philips Electronics (Amsterdam, the Netherlands) reported the availability of triplets monitoring functionality for its line of obstetrical care fetal and maternal monitors, Avalon FM20 antepartum and Avalon FM30 intrapartum. Built on Philips' IntelliVue patient monitoring platform, Avalon FM20 antepartum monitors and Avalon FM30 intrapartum monitors use three channels of high-quality ultrasound tracing and check coincidence between the heart rates of the mother and all fetuses to help ensure each fetus is being monitored. The monitor is designed to display the three fetal heart rates, along with the mother's heart rate, on a color touch screen. Royal Philips Electronics is a provider of medical diagnostic imaging and patient monitoring systems and technologies.
• Siemens Medical Solutions (Malvern, Pennsylvania) has received an approval letter from the FDA for its syngo Lung CAD device, designed to assist radiologists in the detection of solid lung nodules in computed tomography (CT) examinations of the chest. Syngo Lung CAD was validated on the use of CAD in thoracic CT examinations in the largest multi-center, multi-reader study performed to date. Each of the nearly 200 cases was reviewed by 17 radiologists using data from four leading medical centers in the U.S. The use of syngo Lung CAD as a second reader helped all participating radiologists to significantly increase their detection accuracy for clinically significant lung nodules.
• Smiths Medical (Carlsbad, California), part of the Smiths Group, has introduced the Portex Thermovent T2 Heat and Moisture Exchange Device (HME) for tracheostomy tubes, billing it as its new generation of passive humidifiers for tracheostomy tubes. The device provides humidification for spontaneously breathing patients whose upper airways are bypassed by a tracheostomy tube. A centrally located integrated oxygen line connection port enables supplementary oxygen without interfering with other functions of the product. The system features oxygen reservoir end caps that are rounded for added patient comfort, and clear housing that allows visualization of HME. The device may be used for a maximum period of 24 hours and is indicated for use on adult and pediatric patients with a tidal volume greater than 70ml.
• SonoSite (Bothell, Washington) introduced a new high-frequency broadband transducer, the C11e/8-5. With its small footprint, the C11e transducer is designed to provide enhanced image quality and deeper penetration for visualizing the delivery of regional anesthesia and line placement. It is the seventh MicroMaxx system transducer offered by SonoSite for a variety of anesthesiology procedures and assessments. SonoSite claims to be one of the first ultrasound companies with transducers that have regulatory clearance for epidural and lumbar plexus imaging.
• SpectraScience (San Diego) reported filing for a new patent with the U.S. Patent and Trademark Office, titled "System and Method for Non-Endoscopic Optical Biopsy Detection of Diseased Tissue." The device is a disposable catheter designed to be used in body cavities to detect normal or cancerous tissue, used in conjunction with the company's WavSTAT optical biopsy system. The company said its WavStat system is used by physicians to diagnose tissue and determine if it is normal, pre-cancerous, or cancerous within one second. The WavStat is currently approved by the FDA for use in detecting cancer in the colon. A new application for detecting pre-cancers in the throat, sometimes called Barrett's esophagus, is being tested in a clinical trial.
• Spire Biomedical (Bedford, Massachusetts), a provider of surface modification services, was featured at the 39th annual "Renal Week 2006" meeting of the American Society of Nephrology in San Diego last month. Spire introduced the Decathlon Gold End-Point, a bonded heparin coated catheter, which received clearance earlier this year from the FDA for use in long-term hemodialysis treatment. The catheters heparin coating has been effective on a range of medical devices, including vascular grafts, coronary stents, ventricular assist devices and blood oxygenators. The coating is bonded to both the internal and external catheter surfaces and has been shown to maintain 100% of its bioactive properties for a minimum of 90 days.
• ThermoGenesis (Rancho Cordova, California), a developer of technologies for cell therapy and surgical wound care, reported it has scaled-up its production to begin volume shipments of its AutoXpress (AXP) cord blood stem cell processing disposables to fulfill orders to its exclusive global distribution partner GE Healthcare (GEHC; Waukesha, Wisconsin). Earlier this year, GEHC reported agreements with the largest private and public cord blood banks in the world to supply each with ThermoGenesis' AXP System, the first automated, functionally closed, sterile system for harvesting stem cells from cord blood.
• Toshiba America Medical Systems (TAMS; Tustin, California) said it received FDA clearance for a new CAN Level 1 injector synchronization option for its Aquilion 64- and 32-slice computed tomography (CT) systems. The new option facilitates contrast enhanced CT exams by interfacing the CT scanner to a contrast injection system - giving clinicians the option to activate the contrast and the scanner without leaving the patient's side. The new injector protocol will be available on all Aquilion CT systems equipped with Toshiba's Version 3.0 software and is field upgradeable. Version 3.0 software supports synchronization of the injector and CT system using the Level 1 scan protocol option.
• TriPath Imaging (Burlington, North Carolina) and Ventana Medical Systems (Tucson, Arizona) reported that TriPath Imaging has received 510(k) clearance from the FDA for the Ventana Image Analysis System (VIAS) when used with tissues stained for p53, a tumor suppressor biomarker which is used by pathologists as an adjunct to histopathology and is used to assist with diagnosis and the prognostic assessment of cancer. TriPath Imaging makes solutions to improve the clinical management of cancer, including detection, diagnosis, staging and treatment. TriPath Oncology develops molecular diagnostic products for malignant melanoma and cancers of the cervix, breast, ovary and prostate. Ventana makes instrument/reagent systems that automate slide preparation and staining in clinical histology and drug discovery laboratories.
• Tryton Medical (Newton, Massachusetts), a developer of stents designed to treat bifurcation lesions, reported successful completion of the first 10 clinical cases using its Side-Branch Stent. The company said that all of the patients in the trial had coronary blockages involving a side branch and were successfully treated using the stent without any in-hospital complications. The company said that bifurcated lesions account for 20% of all coronary lesions treated. He said the new Side-Branch Stent functions like a standard workhorse stent, but its specific task is to treat bifurcated lesions.
• Ultrasonix Medical (Burnaby, British Columbia) reported launching its Sonix CEP, an Ultrasound system designed for critical care and traumas. The Ultrasonix is intended to deliver high performance imaging in a compact portable system that rolls up to the patient's bedside or gurney. The device is built to power on in seconds with up to 30 minutes of rechargeable battery life to allow emergency medicine physicians to move from room to room and treat multiple patients without losing power. It features the QSonix Quick Exam Wizard that provides one touch access to major applications, probe selections, specific application presets and auto populating patient data targeted at treating critical and emergency patients. Ultrasonix makes diagnostic ultrasound imaging systems.
• Uroplasty (Minneapolis) said that it received FDA pre-market approval (PMA) for its Macroplastique Implants to market Macroplastique in the U.S. for the treatment of female stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency. Following market introduction, the company said it will conduct FDA-required post-approval studies to obtain market feedback on safety and effectiveness of the product. Uroplasty president/CEO, David Kaysen, said, "We have been selling Macroplastique in Europe since 1991 and this approval allows us to commercialize the product in the United States. We expect to begin marketing this product in the United States in early 2007." Macroplastique will be the company's third product on the market in the U.S. Macroplastique Implants is one of what is known as "bulking agents" for SUI in females. The increased bulk from the agent is designed to allow the urethra to close more effectively, preventing urine from leaking during so-called "stress" activities.
• Vasomedical (Westbury, New York) has introduced its Electronic Communication Module (ECM) for the Lumenair EECP Therapy System. The ECM uses Bluetooth technology to wirelessly transfer encrypted patient and treatment data to a dedicated computer. Users are then able to access print and archive patient data with the included laptop or desktop computer and printer. The ECM is designed to be integrated with an electronic medical record software system.
• Verathon (Bothell, Washington) has introduced the GlideScope Ranger, a portable, compact video laryngoscope that provides a clear, real-time view of a patient's airway for fast intubations in unpredictable airway conditions. Designed for "1st Pass Success" in military and emergency settings, the GlideScope Ranger features a blade angulation, a non-glare monitor visible in bright light, an anti-fogging mechanism that resists lens contamination, and rugged, high-impact construction. The device is designed to meet the needs of military physicians and paramedics who work in extreme conditions and regularly treat patients with severe trauma, but Verathon said non-military practitioners also appreciate the advantages of the instrument. The GlideScope Ranger provides a clear picture of the larynx and vocal cords on a display monitor, enabling visual control of the endotracheal tube in its trajectory toward the airway, Verathon said.
• Zimmer (Warsaw, Indiana) said that the first cases using the Trinica Anterior Lumbar Plate (ALP) System have been completed in St. Louis. The Trinica ALP System is the first anterior lumbar plate system to accommodate vertebral body variation through multiple plate configurations with both fixed- and variable-angle screws for an enhanced bone-plate interface. Zimmer Spine expects to complete its full release of the Trinica ALP System in the U.S., Europe and Australia by the end of 2006. It was introduced at the recent North American Spine Society (NASS) conference in Seattle and was highlighted at the Congress of Neurological Surgeons (CNS) conference in Chicago.
• ZOLL Medical (Helmsford, Massachusetts), a maker of resuscitation devices and related software solutions, reported the R Series defibrillator for hospitals. The company expects that the R Series sets a new standard for simplicity and operational readiness, which will help improve in-hospital resuscitation efforts. The R Series debuted at the 2006 Scientific Sessions of the American Heart Association (Dallas) in Chicago. The R Series extends testing beyond shock delivery and checks more than 40 measures of readiness, including the presence of the correct cables and electrodes, the type of electrode, and other important electronics.