The FDA in March approved two advanced glucose monitoring systems from Medtronic (Minneapolis) for use in children and adolescents, with the company saying the devices provide a heightened level of protection for this group against dangerous elevated glucose levels associated with type 1 diabetes. The FDA approved new REAL-Time Continuous Glucose Monitoring (CGM) devices for children and teenagers ages 7-17. Previously approved for only adult patients, Medtronic's REAL-Time CGM will be available in specifically designed pediatric models of the MiniMed Paradigm REAL-Time system and Guardian REAL-Time system.
The company received adult FDA approval for the Guardian in July — though it has yet to be launched in the U.S. — and the MiniMed Paradigm in April.
According to Steve Sabicer, senior manager of public relations for Medtronic's diabetes business in Northridge, California, the approvals system provides an alternative, for young patients, to the traditional fingerstick meter tests that require them to draw blood samples anywhere from three to 20 times a day. Even more importantly, he told Biomedical Business & Technology, is the ability of these systems to monitor these younger patients overnight.
"Parents will have the piece of mind, especially at night, with hypoglycemic events," said Sabicer. He added that when blood sugar gets low, the patient can go into a seizure or coma that can often prove to be fatal. He noted that adults can more easily discern the onset of a hypoglycemic, "but children might not be able to notice or articulate that they are having a problem so the device has built-in alarms that warn a caretaker or patient that they are experiencing a low blood sugar event before it gets to the point where it could induce a seizure or coma."
The devices are not entirely non-invasive but much less invasive than fingersticks. The devices use a tiny electrode placed underneath the skin to measure glucose levels. The electrode is attached to a transmitter about the size of a key FOB which is taped to the patient's abdomen. The transmitter then beams the information obtained from the sensor to a pager-sized receiver typically worn on a patient's belt.
More than one million patients in the U.S. have type 1 diabetes, often referred to as juvenile diabetes. Of the 30,000 new patients diagnosed with type 1 diabetes every year, almost half, or 13,000 patients, are children. There are more than 175,000 type 1 diabetes patients under 20 years of age, and more than one in every 600 children globally has the condition with some recent studies suggesting that the global incidence in children and adolescents is increasing by roughly 3% annually.
Medtronic said its REAL-Time CGM therapy is clinically proven to help patients monitor and better control their diabetes, clinical studies showing that therapy can reduce the duration of hypoglycemic events, and lower HbA1c levels by as much as two percentage points.
This is important because as much as 60% of hypoglycemic events go undetected by current glucose monitoring standards, and for every one percentage point drop in HbA1c, there is a 35% reduction in diabetes-related complications like blindness, amputation and organ failure.
"Diabetes management is especially difficult for pediatric patients, and Medtronic REAL-Time CGM therapy could benefit thousands of children and their families who struggle to maintain control of their disease," said Bruce Buckingham, MD, director of Pediatric Endocrinology at Lucille Packard Children's Hospital at Stanford University (Palo Alto, California). "By providing real-time glucose values and alarms, patients can now recognize previously undetected glucose fluctuations."
The systems display real-time glucose values, trend graphs and directional arrows, allowing patients to discover how diet, exercise, medication and lifestyle affect their glucose level. With this information, Sabicer said patients can gain valuable insights and intervene earlier to reduce the frequency and severity of high and low glucose levels.
The technology alerts patients if their glucose levels fall below — or rise above — preset values, Sabicer said. Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a meter blood glucose measurement may be required.
The company noted, however, that all therapy adjustments should be based on measurements obtained using a home glucose meter and not on Medtronic REAL-Time CGM system values.
Sabicer said the directional arrows are a really useful feature that a traditional fingerstick testing system cannot provide. He said these systems provide a "static" reading, whereas the GCM system directional arrow provides patients with information on which way their glucose levels are trending.
"You have that information in real-time every five minutes and it reinforces your treatment strategy."
While the Guardian — a stand-alone GCM that Sabicer said the company hopes to launch in the U.S. by the end of April — monitors glucose every five minutes to warn the user of high or low levels, the MiniMed Paradigm uses an added pump to deliver insulin and correct levels.
Sabicer said that these systems are precursors to the hoped-for artificial pancreas that would be a closed loop system incorporating both the insulin pump and monitoring system.
He said such a system is still probably "five to seven years away from being on the market."
• Advanced Magnetics (Cambridge, Massachusetts) reported that the independent data monitoring committee (DMC) providing oversight of the ferumoxytol Phase III intravenous iron replacement therapy program met for the final time and informed the company that it reviewed the cumulative safety data from the ferumoxytol Phase III studies and identified no safety concerns. The DMC also recommended the continuation of the ferumoxytol Phase III studies with no modifications. Ferumoxytol, the key product in the company's development pipeline, is in Phase III multi-center clinical trials for use as an intravenous iron replacement therapeutic in chronic kidney disease patients, whether or not on dialysis. Advanced Magnetics is a developer of superparamagnetic iron oxide nanoparticles used in pharmaceutical products.
• AgeSpan (San Diego) has introduced the SAM (Senior Assisted Living) Cam, a camera system for combating nursing home abuse. The camera does not require a separate power cord since it runs off the power provided in the Ethernet connection, a feature resulting in faster installation times than the typical CCTV installations as well as the use of no electrical subcontractors, AgeSpan said. It can record up to 30 days of continuous video stream on any computer's hard drive thereby eliminating the need for digital video recording devices and tapes. AgeSpan is an Internet enabling solution for seniors in the U.S.
• Asthmatx (Mountain View, California) said that positive results from the research in its severe asthma trial were reported at the annual meeting of the American Academy of Allergy, Asthma & Immunology (Milwaukee) in San Diego. Statistically significant improvements in pulmonary function, asthma control, and quality of life, as well as a reduction in use of rescue medications, were observed following the bronchial thermoplasty procedure in patients with severe asthma. Bronchial thermoplasty is an investigational procedure in which thermal energy is delivered with a tiny catheter to targeted airway walls of patients with asthma. This procedure is intended to reduce muscle in the walls of airways, and thereby decrease the ability of airways to narrow in patients with symptomatic asthma. Asthmatx is focused on catheter-based devices for the treatment of asthma.
• Baxter Healthcare (Deerfield, Illinois) reported launch of a Phase II clinical trial to determine if adding peritoneal ultrafiltration treatments using its icodextrin solution to the current standard congestive heart failure (CHF) therapy regimen will improve clinical outcomes and reduce the amount of time patients spend in the hospital. Each patient will be randomly selected to receive either the current standard CHF therapy or the standard therapy plus peritoneal ultrafiltration using Baxter's icodextrin solution. In this process, the solution is infused through a catheter into the abdominal cavity, which is lined by the peritoneal membrane. This membrane serves as a natural filter, across which the solution draws out toxins and fluid. The used solution is then drained from the body. The treatment period will be six to 24 months with the primary outcome measure being impact on hospitalization rate. Also being evaluated is the effect on quality of life and medication use. Baxter International, through its subsidiaries, assists healthcare professionals and their patients with treatment of medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma.
• Bayer Diabetes Care (Tarrytown, New York), a division of Bayer HealthCare, reported the availability of advances in its line of blood glucose meters: the new Contour and Breeze 2 meters. The product requires a small blood sample (1 L) size and includes a 10-test disc system, allowing users to test 10 times without handling individual strips. Bayer Diabetes Care makes diabetes devices.
• Biomet (Warsaw, Indiana) reported that Biomet 3i, the company's dental reconstructive device subsidiary, has introduced a new dental implant that uses nanotechnology. The NanoTite implant builds upon Biomet 3i's Osseotite implant by adding deposits of nano-scale calcium phosphate crystals to about 50% of the surface. According to pre-clinical studies, those nano-scale deposits create a complex surface on the implant that appears to play a role in how the implant bonds with the bone, the companies said. Human bone recognizes calcium phosphate as biologically natural, allowing the bone and implant to bond during healing. Dental implants replace single or multiple missing teeth due to cavities, decay, trauma or disease and are designed to help preserve bone structure and natural facial contours. Biomet and its subsidiaries make products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy.
• BioSphere Medical (Rockland, Massachusetts) reported that a study published in the March 2007 issue of the Journal of Vascular and Interventional Radiology concluded that over the long term, uterine fibroid embolization using BioSphere Medical's Embosphere Microspheres is safe and effective, with high levels of durable symptom control, improved health-related quality of life and patient satisfaction. Among the key findings of the study were: 72% of patients had known outcomes at three years after treatment, 88.4% of the patients with known outcomes completed a three-year follow-up without the need for a major intervention, 8.3% of the patients underwent fibroid surgery within three years. Biosphere is focused on applying microsphere technology to medical applications using embolotherapy techniques.
• Ciphergen Biosystems (Fremont, California) said it presented data from a prospective clinical trial demonstrating that its ovarian triage test correctly identified 84% of the ovarian cancer cases, compared to only 33% identified using standard diagnosis methods without the test. Ciphergen, along with its scientific collaborators, has ongoing diagnostic programs in oncology/hematology, cardiology and women's health with an initial focus in ovarian cancer.
• Cleveland Clinic (Cleveland) reported recently receiving four U.S. patents in ophthalmology, cardiology and for developing a support pad for surgical patients. The first patent (U.S. Patent No. 7,172,874) was received for a new method of screening and diagnosing age-related macular degeneration. The new technique helps determine if a patient has or is at risk for developing age-related macular degeneration. A second patent (U.S. Patent No. 7,169,106) was issued for a new device designed to measure intraocular pressure using a miniature sensor that is mounted on a contact lens. The third patent (U.S. Patent No. 7,175,597) was issued for a new noninvasive ultrasound device that provides cardiologists with images of blood vessels, allowing them to assess the vessels' composition and plaque contents, the clinic said. The fourth patent (U.S. Patent No. 7,168,116) covers the development of a new surgical support pad that conforms to a patient's body and distributes body weight to alleviate pressure points and improve patient comfort during medical and surgical procedures.
• Cook Urology (Spencer, Indiana), a division of Cook Medical (Bloomington, Indiana), reported introduction of the 1.5 French NCircle tipless stone extractor for kidney stone treatment. Using Cook's nitinol tipless technology, the 1.5 French NCircle enables the capture of even the most challenging kidney or ureteral stones to render patients stone-free. The extractor is made from nitinol, a shape-memory alloy that combines nickel and titanium. The minuscule basket retains its shape following extreme torsion, yet is flexible enough for a physician to guide during stone manipulation without damage to surrounding renal tissue. Cook Medical makes minimally-invasive medical device technology for diagnostic and therapeutic procedures.
• Cytogen (Orlando, Florida) reported that cancer center clinical investigators presented data from recent and ongoing clinical trials of both Prostacint (capromab pendetide) and Quadramet (samarium Sm-153 lexidronam injection) in prostate cancer at the 2007 Prostate Cancer Symposium. Prostascint molecular imaging agent targets prostate-specific membrane antigen (PSMA), a protein expressed on the surface of prostate cancer cells, with an increased expression in high-grade cancers, metastatic disease and hormone-refractory prostate cancer. Quadramet is an oncology product for the treatment of pain arising from cancer that has spread to the bone. It pairs the targeting ability of a small-molecule, bone-seeking phosphonate with the therapeutic potential of radiation (samarium Sm-153).
• Delcath Systems (Stamford, Connecticut) reported "encouraging" interim results from its ongoing Phase II multi-histology trial of the treatment of unresectable primary and metastatic cancers of the liver using the Delcath system with melphalan. The results, presented at the International Symposium on Regional Cancer Therapies, revealed that of the 14 patients for which data is available, 12 were evaluable, and that objective tumor responses, including partial and complete responses, were observed in nine of the 12 patients treated using the Delcath system with melphalan. The results also revealed that a significant and durable tumor response was observed in patients with large volume, unresectable hepatic metastases. Delcath develops percutaneous perfusion technology for organ or region-specific delivery of therapeutic agents.
• DePuy Spine (San Diego), a business of Johnson & Johnson (New Brunswick, New Jersey) introduced the AEGIS anterior lumbar plate system, designed to treat degenerative conditions of the lumbar spine. AEGIS is contoured to recess into the space between two vertebral bodies and features angled tabs (15 degrees) that attach the plate to the cortical rim (anterior edge) of the vertebrae. The plate also uses a patented screw locking mechanism that uses cams instead of screw covers or other means to hold the screws in place. The Tri-lobe CAM-LOC apparatus adds no additional profile to the construct and provides positive feedback that the screws are locked. AEGIS has a semi-rigid design that allows for load-sharing between the construct and the bone graft, reducing the risk of screw breakage and encouraging fusion. DePuy Spine makes orthopedic devices and supplies.
• eyeonics (Aliso Viejo, California) reported that the crystalens Five-O is now available in an expanded range of 10 to 30 diopters. In addition, in the range of the most commonly used diopters, 16 to 27, the Five-O is available in quarter (0.25) diopter steps to provide ophthalmic surgeons with a more precise selection of lenses to achieve their refractive targets. The Five-O is now also manufactured in a 12mm overall length from 10 to 16.75 diopters to accommodate larger eyes. The crystalens technology is designed to allow the lens to move in the eye in a manner similar to the natural lens. By using the eye's muscle to move the lens backwards and forwards naturally, patients can focus through a continuous range of vision including near, far and intermediate vision. eyeonics says it is developing a new class of visual enhancement systems that will enable patients to see up close, far away and all distances in between.
• InSightec (Tirat Carmel) reported receiving FDA approval for software that the company said "significantly speeds up" the treatment time of its ExAblate 2000 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) system. The FDA also approved the ExAblate 2000 to be used with a 3.0 Tesla MRI scanner, in addition to the 1.5 Tesla version. InSightec also reported that Canada's healthcare regulatory body, Health Canada, has granted regulatory approval to the ExAblate 2000 system for the treatment of symptomatic uterine fibroids. The MRgFUS technology combines MRI — to visualize tissues in the body, plan the treatment and monitor in real time treatment outcome — and high-intensity focused ultrasound to thermally ablate uterine fibroid tissue. The new software version uses an "interleaved" mode of treatment whereby the system targets different parts of the fibroid, allowing the recently ablated tissue area to cool while the focus moves onto other areas of the fibroid. This reduces the cooling time required. Another new feature allows physicians to leverage the beam steering in phased array transducer to maximize the energy in the focal point, allowing significantly more volume to be treated for the same amount of energy applied. The new version was previously available in Europe and Asia. The company said that, to date, more than 2,500 women have been treated with the ExAblate worldwide. Doctors from the Mount Sinai Hospital and University Health Network Joint Department of Medical Imaging (Toronto) are conducting clinical studies on uterine fibroids, pain palliation of patients suffering from advanced bone metastases and breast tumors using the ExAblate 2000. InSightec is a subsidiary of Elbit Medical Imaging (Tel Aviv).
• MAP Pharmaceuticals (Mountain View, California) said it has designed the Tempo inhaler which incorporates a standard meter dose inhaler medication canister with a synchronized trigger and flow control chamber. The company said the inhaler is breath-synchronized so all the patient has to do is put it to their mouth and breathe - the device does the rest. The company said that one spray from the Tempo inhaler is capable of delivering three times as much of the drug down into the lung than with a standard inhaler.
• Maquet Critical Care (Bridgewater, New Jersey) reported in late February that it received FDA clearance for its NAVA (Neurally Adjusted Ventilator Assist) technology for optional use with the company's Servo-i ventilator, which has been in use in some form since the 1970s, according to the company. The NAVA technology detects respiratory signals sent from the brain to the diaphragm — at least in those cases where the brain-to-diaphragm electrical signal is intact — and transmits those signals to the Servo-i ventilator.
• Masimo (Irvine, California) reported that an independent study demonstrated the superiority of Masimo LNOP Blue Sensors in providing accurate, reliable and continuous pulse oximetry readings in cyanotic infants with congenital heart disease. The Masimo LNOP Blue sensor — which was specifically designed for use in pediatric patients with low oxygen saturation — was compared to a Nellcor OxiMax sensor and to a standard Masimo LNOP sensor not designed for cyanotic patients, and was shown to have a "significantly higher correlation to arterial blood gas in comparison to the two other sensors studied." Masimo assists clinicians to accurately monitor blood oxygen saturation in critical care situations.
• Medstrat (Downers Grove, Illinois) reports the integration of the CompuMed (Los Angeles) OsteoGram bone mineral density (BMD) measurement software for osteoporosis screening, diagnosis and monitoring with its echoeSYSTEM PACS software suite. The integration of Medstrat's orthopedic digital imaging solutions with CompuMed's OsteoGram software provides orthopedic surgeons with a simple, effective and affordable means of identifying at risk individuals in their community, the company said. HHS recommends bone density tests for all women over 65 and for any man or woman who suffers even a minor fracture after age 50. CompuMed provides advanced imaging and medical informatics solutions. Medstrat makes digital medical imaging software for orthopedic practices.
• Nanogen (San Diego) reported being issued four patents by the U.S. Patent and Trademark Office for inventions related to diabetes and Alzheimer's disease biomarkers, the most recent in a series describing biomarkers associated with these diseases. U.S. Patent No. 7,179,610, "Complement C3 precursor biopolymer markers indicative of insulin resistance," and U.S. Patent No. 7,132,244, "Betaine/GABA transport protein biopolymer marker indicative of insulin resistance," describe the use of mass spectrometry and time-of-flight detection techniques to identify biopolymers that could potentially be used in the diagnosis of or development of therapeutics for the metabolic conditions Syndrome X and type II diabetes. U.S. Patent No. 7,179,605, "Fibronectin precursor biopolymer markers indicative of Alzheimer's disease," and U.S. Patent No. 7,179,606, "IG heavy chain, IG kappa, IF lambda biopolymer markers indicative of Alzheimer's disease," relate to the identification of protein biomarkers for Alzheimer's disease.
• Ortho Organizers (Carlsbad, California), maker of orthodontic products, reported introducing OrthoShield Orthodontic Antimicrobial Technology developed in partnership with AgION Technology (Wakefield, Massachusetts). The technology, to be incorporated into several products and designed to help in reducing microbial growth on treated surfaces. The technology consists of a patented delivery process that releases non-toxic, natural silver ions in the presence of moisture. Ortho Organizers' OrthoShield Orthodontic Antimicrobial products are embedded with silver ions which effectively reduce and inhibit microbial growth on the surfaces of OrthoShield Orthodontic Antimicrobial Technology products throughout the life of the product.
• PLC Medical Systems (Franklin, Massachusetts) reported completing enrollment of the first three patients in its FDA-approved pilot clinical trial designed to evaluate the safety of its RenalGuard System, the name very clearly indicating the systems purpose: protecting the renal system. Therapy using RenalGuard is intended to reduce the incidence of CIN by managing real-time fluid balance and diuresis in conjunction with interventional procedures, such as percutaneous coronary intervention (PCI) and other radiology procedures requiring contrast media. CIN is a condition whereby nephrons, or cells specific to the kidneys that filter those organs, are seriously injured or damaged by contrast media, reducing their ability to function. And as procedures such as angioplasty and drug-eluting stent placements become more common, CIN is likely to increase — and with it the mortality related to CIN. A diuretic is given to the patient before the cath procedure, and the RenalGuard therapy is then initiated — also before the procedure begins — and ends when the patient is able to leave the lab. Safety results have been "favorable," according to the company, and no adverse events related to the device. The FDA granted the company an investigational device exemption in December to test 40 patients in four centers. Since then the company has been "aggressively and actively screening" to enroll. The first procedures in the study, all done in conjunction with a percutaneous coronary intervention (PCI) employing multiple stents, were performed by Richard Zelman, MD, at Cape Cod Hospital (Hyannis, Massachusetts).
• Power3 Medical Products (Houston) reported filing a patent application for 47 new biomarkers it has discovered for use in the early diagnosis and detection of neurodegenerative diseases, including Alzheimer's, Parkinson's and ALS. Power3 has 15 patents pending with the U.S. Patent and Trademark Office, including a filing earlier this week for 10 new biomarkers for early detection and treatment of breast cancer. That patent application is in addition to an earlier utility filing in December 2006 for 12 other protein biomarkers in blood serum. Power3 Medical Products is a producer of protein biomarkers, pathways, and mechanisms of diseases, through the development of diagnostic tests and drug targets for cancer and neurodegenerative diseases.
• Roche Diagnostics (Basel, Switzerland) reported introducing an advancement in point-of-care (POC) anticoagulation monitoring, the CoaguChek XS system, for physician's office use and self-testing by patients on warfarin therapy. The product offers benefits for managing in-office prothrombin time (PT/INR) testing more effectively. The company says CoaguCheck XS is the only anticoagulation monitoring system to perform onboard quality control in the reagent chamber and also neutralizes therapeutic levels of heparin and LMW heparin. Performing PT/INR (clotting time) testing POC rather than at an outside lab enables dosage adjustments to avoid serious complications. Roche is a healthcare group in the fields of pharmaceuticals and diagnostics.
• StatSure Diagnostic Systems (Framingham, Massachusetts) reported filing a patent application for an integrated, saliva collection and testing device to detect and screen for sexually transmitted and infectious diseases. In addition to saliva, the patent covers collection of other physiologic fluids including whole blood and serum samples. The device incorporates StatSure's "sample volume adequacy indicator" control system, which is an internal quality control mechanism incorporated into the Company's existing line of oral fluid collection devices. The product will complement StatSure's "barrel" testing platform used for rapid, point-of-care blood-based testing, for infectious diseases. StatSure Diagnostic Systems makes rapid immunoassay tests for the detection of sexually transmitted and other infectious diseases.
• Royal Philips Electronics (Amsterdam, the Netherlands) has introduced its ProtocolWatch, an application available on Philips IntelliVue patient monitors that applies data to evidence-based care protocols for early detection of sepsis. The company said that the ProtocolWatch is the first application to deliver customer-specific care protocols on the patient monitor screen to offer relevant screening and treatment information from evidence-based care guidelines. In its initial release, ProtocolWatch brings the care guidelines developed by the Surviving Sepsis Campaign (SSC), published in the New England Journal of Medicine in 2001, to the Philips IntelliVue patient monitoring platform. The SSC protocol defines the physiological parameters that indicate the onset of severe sepsis. ProtocolWatch is built into the patient monitor and can use the patient's vital signs to help screen for this condition. Once one of the parameters that act as an early warning sign for sepsis reaches the limits defined by the SSC protocol, a ProtocolWatch window appears on the monitor screen. This window prompts clinicians to check for other clinical signs of severe sepsis. Philips said it plans to add more evidenced-based care protocols to the ProtocolWatch, but for now the sepsis screening is the first.
• Stereotaxis (St. Louis) reported initiating the HEAL HF clinical trial, designed to evaluate the ability to magnetically navigate to multiple potential pacing sites and then optimize LV lead placement to treat heart failure. The case included the evaluation of seven pacing sites in the left ventricle, which exhibited significant differences from site-to-site in the hemodynamic response of the patient's heart, measuring cardiac function. The Stereotaxis magnetic guided lead placement system is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced X-ray exposure. Stereotaxis makes cardiology instrument control systems.
• St. Jude Medical (St. Paul, Minnesota) reported FDA clearance for the Venture wire control catheter on a rapid exchange delivery platform, a delivery design that accommodates shorter guidewires and may result in quicker, easier coronary procedures. The catheter is designed with a deflectable tip — a feature that allows interventional cardiologists to treat difficult-to-reach areas of the coronary anatomy. Capable of bending 90 degrees, the deflectable tip helps physicians with control and precision when navigating complex turns in the artery, and it provides guidewire support when attempting to access partially blocked vessels. With approval of the rapid exchange delivery platform, the catheter now accommodates guidewires of any length, including the shorter guidewires most commonly used in interventional procedures. St. Jude Medical has five focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation.
Additionally, the company reported the first patient implant in a pilot study that will provide preliminary evaluation of the ability of a stimulation system to stimulate the nerves near the spinal cord to control chronic angina chest pain. A 53-year-old Massachusetts woman was the first person to receive this investigational device, called the Genesis neurostimulation system. She is one of the 1.3 million Americans — estimated by the American Heart Association (Dallas) — who suffer from chronic angina, with 75,000 new cases of treatment-resistant angina each year.
• ThermoGenesis (Rancho Cordova, California) reported that the U.S. Patent and Trademark Office has granted notice of allowance of claims for the first two patents for the AutoXpress system and has granted an additional patent that extends coverage on the CryoSeal system. The two patents, both titled "Blood Component Separation Method and Apparatus" protect the key device claims that enable this semi-automated method of isolating and capturing cell populations from cord blood, peripheral blood and bone marrow in a sterile, functionally closed system during centrifugation. ThermoGenesis makes technologies for cord blood stem cell therapy and surgical wound care.
• Varian (Chicago) introduced its new 900-MS series Fourier Transform mass spectrometers. (FTMS). Due to ultra-high resolution, these instruments are ideal for a variety of application areas including proteomics, metabolomics, petrochemical and environmental analyses. The available field strengths of the magnets include 7, 9.4, 12.0 and now 15.0 Tesla — the highest commercially available FTMS magnet. Varian makes scientific instruments and vacuum technologies for life science and industrial applications.
• VNUS Medical Technologies (San Jose, California) said that the first report of six-month follow-up clinical results from a trial of the ClosureFAST endovenous radio frequency (RF) vein ablation catheter was given at the American Venous Forum meeting. In the study, treatments with the ClosureFAST catheter resulted in an average energy delivery time of 2.2 minutes, and the average procedure time (measured from catheter insertion to catheter removal, including the time for administration of tumescent anesthesia) was 16.4 minutes. The ClosureFAST catheter is designed to heat, shrink and occlude refluxing saphenous veins with RF ablation times of three to five minutes while maintaining fast and mild patient recovery that physicians expect with RF vein ablation.
• W.L. Gore & Associates (Flagstaff, Arizona) reported that the first patient has been enrolled in a FDA-approved IDE study for the 45 mm GORE TAG thoracic endoprosthesis for treatment of aneurysms of the descending thoracic aorta. The device provides a minimally invasive alternative to open surgery for treatment of aneurysms of the descending thoracic aorta. The device internally relines the thoracic aorta and isolates the diseased segment from blood circulation. It is comprised of an ePTFE graft with an outer self-expanding nitinol support structure to combine both device flexibility and material durability. The device is inserted by a catheter delivery technique through a small incision in the patient's groin. Gore Medical produces vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery.
• Wright Medical Group (Arlington, Tennessee), reported launch of the Evolve Proline Radial Head System for radial head replacement. The system is the latest improvement in the Evolve prosthesis, allowing the implant to be inserted without surgical dissection of intact elbow ligaments, reducing the invasiveness of the procedure. This advance and additional sizes expand the addressable market for radial head replacement. Also, new implant sizes enable the surgeon to address both the radiocapitellar joint (RCJ) and the proximal radioulnar joint (PRUJ) independently. Conventional designs attempt to address the RCJ, but do not permit anatomic flexibility in addressing the PRUJ, the company said. Wright Medical specializes in making reconstructive joint devices and biologics.
• Zimmer Holdings (Warsaw Indiana) and ISTO Technologies (St. Louis) reported a clinical trial is under way for Neocartilage, a living tissue-engineered graft under investigation for the restoration of cartilage defects, reestablishment of joint function and relief of pain in the knee. To be marketed as DeNovo ET, the product is a living tissue graft grown from juvenile chondrocytes (cartilage cells) using a cell-based technology from ISTO. Studies have demonstrated that juvenile chondrocytes produce cartilage significantly better than their adult counterparts. Cartilage works as a low friction articulating surface to protect joints from wear and tear experienced during motion. Articular cartilage can be damaged as a result of injury, or can simply deteriorate over time leading to osteoarthritis. ISTO is an orthobiologic company developing products for sports medicine and spinal therapy using a cell-based platform technology. Zimmer makes orthopedic products.