Proving that patience is truly a virtue, Micro Therapeutics (MTI; Irvine, California) reported in late July that it had received premarket approval (PMA) from the FDA for its Onyx liquid embolic system (Onyx) for the treatment of arterio-venous malformations (AVMs), a vascular disorder in the brain. The final approval came nearly two years after the agency’s Neurological Devices Panel voted seven to one in favor of approval, with one abstention and more than four years after the FDA okayed the company’s trial design for use of the system in AVMs.

“The important thing is that it’s out,” said President and CEO Thomas Wilder, not wanting to dwell on the delay. He told The BBI Newsletter that the Onyx system “is a complex new technology, and neurovascular conditions are a complex disease state. I would have liked to have seen [approval] earlier, but I’m just pleased that it has happened.” Wilder also noted that the neurovascular space does not have very many PMAs, adding that he believed that the Onyx system is one of only two neurovascular devices to ever go the PMA route.

While the FDA panel recommended the system for approval, concerns were raised over the safety of the device by several members of the advisory panel after learning that three patients in the clinical trial died following the procedure. The deaths were unfortunate, but could not be directly associated with the use of the Onyx system, Donald Larsen, MD, chairman of the data safety monitoring board for the clinical trial, told members of the panel.

Elsewhere in the product pipeline:

• Abbott Diabetes Care (Alameda, California), said it has received FDA 510(k) clearance to market the FreeStyle Connect blood glucose monitoring system in the point-of-care setting, such as hospitals and medical clinics. The company said the system would be available this month. FreeStyle Connect measures glucose levels using a very small blood sample size (0.3 micro liter), which Abbott said is the smallest sample size required of any point-of-care blood glucose monitoring product on the market. The device uses a technology based on coulometric measurement, an electrochemical technology that measures virtually all of the available glucose in the blood sample, making it ideal for measuring a small sample size. Its accuracy has been tested in three clinical studies. The company added that the FreeStyle Connect also is the fastest point-of-care blood glucose monitoring system available, providing results within an average of 15 seconds. Results are not affected by substances such as aspirin, acetaminophen, gentisic acid, uric acid, vitamins, and many over-the-counter drugs. FreeStyle Connect also is designed to seamlessly interface with any open point-of-care data management system. Abbott Diabetes Care is a division of Abbott Laboratories (Abbott Park, Illinois).

• American Bio Medica (ABMC; Kinderhook, New York), a manufacturer of immunoassay diagnostic test kits, said that the FDA has granted the company 510(k) clearance on its Rapid Reader, a personal computer peripheral that interprets, scans, transmits, records and stores the results of ABMC drug screens. As the first FDA-cleared all-inclusive drug screen result interpretation and data management system, the Rapid Reader is a compact, portable device that, when connected to any computer, captures a picture of the test results on an ABMC drug screen using a high resolution camera. The Rapid Reader’s software analyzes this image and interprets the results. The information is then sent to a data management system, which enables the user to interpret, store, transmit and print the drug test results.

• ATS Medical (Minneapolis) reported that it has achieved a second milestone in its development of the Particle Separation by Ultrasound (PARSUS) technology for auto-transfusion in cardiac surgery by creating a prototype of a working disposable made of medically compatible materials that separates in excess of 90% of lipid micro emboli. ATS said that development is regarded as new evidence of the feasibility of PARSUS, which enables effective filtering by ultrasound waves of the undesirable foreign particles that become mixed in blood during cardiac surgery procedures. The company said PARSUS would allow physicians to give back to patients lost blood in a safe and efficient manner, potentially reducing the many complications currently associated with blood transfusion. It said the technology has the potential for use in all patients requiring cardiac surgery procedures, including heart valve replacement or repair and coronary artery bypass. ATS said the technology addresses a market opportunity estimated at about $150 million. The company has exclusive worldwide rights to the PARSUS filtration for cardiac surgery. The technology is owned by ErySave AB, a Swedish research firm founded in 2000 by a team from Lund Institute of Technology and Lund University Hospital.

• Beckman Coulter (Fullerton, California) has introduced Hemoccult ICT, an immunochemical fecal occult blood test (iFOBT) used for detecting fecal occult blood as an aid in colorectal cancer screening. Calling it the latest addition to its “market-leading Hemoccult product family,” the company said Hemoccult ICT “offers higher clinical sensitivity than traditional, guaiac-based tests, without compromising specificity for lower gastrointestinal (GI) bleeding.” The test requires no drug or dietary restrictions. Noting that the American Cancer Society recommends regular colorectal cancer screening for persons past the age of 50 and for those at average risk of developing colorectal cancer, Beckman Coulter said studies have shown that more than half the more than 80 million Americans over age 50 have not been screened.

• Biomet (Warsaw, Indiana) reported that the FDA has granted marketing clearance for the company’s StageOne Disposable Spacer Molds for knee revision surgery, making it the first company to receive clearance in the U.S. to market disposable molds specifically designed for revision surgery. The StageOne spacer molds are a series of silicone molds designed to be used in revision knee surgery following infection. Biomet is currently making four sizes of both tibia and femur molds under the StageOne name and plans to launch those products this month, targeting the orthopedic surgeon market. The molds already are approved for sale in Europe and Canada.

• Clinical Data (Newton, Massachusetts) has received FDA 510(k) clearance for a new hematology analyzer, the Excyte Pro-Diff 5. The company said it would immediately begin distributing the analyzer and consumables under an exclusive distribution agreement for North America with the developer of the instrument, Melet Schloesing Laboratoires International (Cergy-Pontoise, France). The analyzer and consumables are to be distributed under the Clinical Data brand name. The Excyte Pro-Diff 5 is a fully-automated device used to count red blood cells, white blood cells, platelets, measure hemoglobin and calculate or measure several red cell indices, including erythrocyte mean corpuscular volume, mean corpuscular hemoglobin, and the mean corpuscular hemoglobin concentration. Differential cell counting is used to diagnose such conditions as anemia, infections, allergic reactions and platelet disorders. Millions of such tests are performed daily in hospitals and physicians’ offices worldwide, Clinical Data said.

• Collagen Matrix (Franklin Lakes, New Jersey) said it has received FDA 510(k) clearance of its natural anorganic bone graft material intended for use in oral surgical applications involving bone repair. The products include the anorganic bone mineral alone, anorganic bone mineral with collagen, and anorganic bone mineral with collagen in the block form. The natural anorganic bone graft material is derived from bovine cancellous and cortical bone. A proprietary process has been developed to remove the organic components of the bone, leaving the natural mineral component for use as an osteoconductive material in bone-repair applications. The addition of type I collagen to the anorganic bone mineral extends the product offering to a mineral-collagen composite bone graft material intended to enhance the ease of handling, the company said.

• Conceptus (San Carlos, California), developer of the Essure non-incisional permanent birth control procedure, reported that it has received FDA approval to extend effectiveness data on the Essure product labeling. The premarket approval (PMA) supplement filed in January supports an extension of the effectiveness rate of Essure to 99.80% after four years and 99.74% after five years of follow up, from the previously approved 99.80% at three years. The five-year effectiveness was demonstrated in a portion of the women undergoing clinical studies and follow up of the remaining clinical trial patients is ongoing. The PMA supplement was supported by Phase II and pivotal clinical trial data demonstrating zero pregnancies in more than 29,000 women. There continue to be no pregnancies to date among patients who had been enrolled in the Essure Phase II and pivotal trials.

• Dade Behring (Deerfield, Illinois) said that its Dimension Vista 1500 integrated system, the company’s first integrated chemistry/immunochemistry system targeted at high-volume clinical laboratory customers, has received 510(k) clearance from the FDA. This is the first of a series of submissions and approvals prior to the anticipated commercialization of the Dimension Vista system in the second half of 2006. The Dimension Vista 1500 integrated system will combine photometry, turbidemetry, nephelometry, integrated multisensor technology and LOCI technologies. The new design will integrate analysis of electrolytes, general and special chemistries, drugs-of-abuse, therapeutic drugs, immunosuppressive drugs, plasma proteins, cardiac marker tests and high-sensitivity immunoassays into one analyzer.

• DePuy Spine (Raynham, Massachusetts) said that safety and efficacy data from the clinical trial that led to the approval of the Charité artificial disc by the FDA were published in the July 15th issue of Spine. The randomized, multi-center trial compared the safety and effectiveness of total disc replacement with the Charité disc to anterior lumbar interbody fusion with BAK cages for the treatment of single-level degenerative disc disease. In the two-year study sponsored by DePuy Spine, patients from both treatment groups improved significantly following surgery, but the patients who received the Charité artificial disc had shorter hospital stays, recovered faster, had lower levels of disability, maintained range of motion and were more satisfied with their procedure after 24 months, according to the Spine report. While the complication rate was similar in both groups, the rate of re-operations was significantly less for the Charité group at 5.4% vs. 9.1%. A second part of the paper published in the journal analyzed the correlation between radiographic and clinical outcomes, showing that on average, Charité patients had a 13.6% increase in flexion/extension range of motion, compared to an 82.5% decrease in fusion patients. They also had a better restoration of disc height and less subsidence than did fusion patients, and at 24 months had a 73.7% rate of satisfaction compared to 53.1% in the fusion group.

• Eastman Kodak’s (Rochester, New York) Health Group has introduced new medical imaging and information systems designed to enhance efficiency and improve patient care by offering faster, more accurate diagnostic results. The new products include a digital imaging system and software that the company said improves image analysis and information management. The products include the Kodak Directview CR 975 System, a computed radiography system that provides better visualization than prior systems for areas of the body that are traditionally difficult to image, according to the company. It said wait times may be shortened due to the CR 975 system’s rapid processing of digital images. Also introduced was a new Kodak radiology information system (RIS) designed for outpatient imaging centers that the company said streamlines the scheduling of patient exams and provides tools for better utilization of employees and imaging equipment. It said the information system also expedites the delivery of reports and images to referring physicians.

• Health Discovery (Savannah, Georgia), a biomarker and pathway discovery company, said it has received notices from patent offices in four different countries regarding the acceptance or issuance of five different patent applications covering aspects of its support vector machine (SVM) technology. The U.S. Patent and Trademark Office has issued a notice of allowance of the company’s claims covering the use of SVMs in computer-aided image analysis. The Australian Patent Office issued two patents to the company in June. The first, Australian patent No. 780050, covers a tiered arrangement of SVMs that provides for the analysis of multiple data sets, such as distinct data types, to produce a single output. The second issued patent, Australian patent No. 779635, discloses and claims the use of recursive feature elimination in SVMs.

• Medtronic Diabetes (Northridge, California) is one step closer to ultimately having an artificial pancreas for diabetic patients with the PMA supplement approval of its Guardian RT continuous glucose monitoring system, which measures glucose levels in the interstitial fluid, where cells get oxygen and nutrients, including glucose. The Guardian RT System uses a glucose sensor, a transmitter and a monitor. Included with the system is a docking station and therapy management software, the company said, which allows patients and healthcare professionals to download information to a computer to view trend reports and charts. The system continuously measures glucose levels around the clock, even during sleep. If glucose levels get too high or too low, the device sounds an alarm or vibrates. Deanne McLaughlin, communications manager for Medtronic Diabetes, told BBI that this is really the first “viable device” for continuous glucose monitoring entering the market for consumers. The previous iteration of the device allowed continuous glucose monitoring, but patients had to visit their doctors, who would download the information, she said. The Guardian RT is meant specifically for consumers. “It’s designed to display real-time glucose values every five minutes, and so what you really get is ... about 288 fingersticks a day with this technology, as opposed to the two to three fingersticks that [diabetics] would normally take,” she said. The device will be launched in certain U.S. cities, which will be announced this month. Based on the sPMA secured from the FDA, the device can be used by those age 18 or older with either Type 1 or Type 2 diabetes.

• Misonix (Farmingdale, New York), a developer of ultrasonic medical device technology for the treatment of cancer and other purposes, reported that its subsidiary, Sonora Medical Systems (Longmont, Colorado) received its first U.S. patent, the initial patent of three filed, for its FirstCall 2000 ultrasound probe-testing device and covering the device’s process for testing ultrasound probes on site. The patent relates to its ability to test the probes one element at a time and enabling the objective evaluation of the health of ultrasound transducers. The inventors of U.S. patent No. 6,920,776 are James Gessert; G. Wayne Moore, president and CEO of Sonora; and William Phillips. Michael McManus Jr., president and CEO of Misonix, estimated the worldwide market for probe testing equipment in excess of $50 million, “with potential customers including every healthcare facility using ultrasound devices.” In July, the FirstCall 2000 device was featured during three ultrasound quality assurance presentations at the American Association of Physicists in Medicine meeting in Seattle. Sonora Medical Systems is a provider of products and services to the diagnostic ultrasound and MRI markets.

• Nipro Diabetes Systems (Miramar, Florida) has introduced the Amigo Insulin Pump to help keep blood glucose in control for children and adults with types 1 and 2 diabetes. The Amigo Insulin Pump features computer-like help screens for easy programming, the company said. The Amigo Insulin Pump delivers basal insulin throughout the day and night, allowing the wearer to program insulin whenever needed. It utilizes rapid-acting insulin that is similar to the insulin produced by the human pancreas, Nipro said. The company describes the Amigo as a “smart” pump because it is capable of calculating bolus insulin for food and high blood glucose readings through parameters prescribed by the physician and stored in the pump. The pump offers four basal profiles with up to 48 basal rates in a 24-hour period and a temporary profile that can be set in either units per hour or a percentage of the current basal profile. It delivers insulin every three or 15 minutes in as little as five-hundredths of a unit.

• Novadaq Technologies (Toronto), developing medical devices based on its imaging platform for the diagnosis and treatment of vascular and ophthalmic conditions, said that it has been granted a patent by the U.S. Patent and Trademark Office for the SPY Intra-operative Imaging System. The FDA-cleared SPY System enables real-time visual confirmation of revascularization during heart bypass surgery, which the company said allows bypass graft technical errors to be detected and corrected while the patient is still in the operating room. U.S. patent No. 6,915,154 B1, “Method and apparatus for performing intra-operative angiography,” describes the SPY intra-operative fluorescent imaging system that enables cardiac surgeons to confirm the location of coronary arteries during coronary artery bypass graft procedures and visually assess and validate the functionality of bypass grafts.

• Novasys Medical (Newark, California) reported that its Renessa System has been cleared for marketing by the FDA for the treatment of stress urinary incontinence (SUI) due to hypermobility in women who have failed conservative care and are not candidates for surgical therapy. The company said the system offers women a non-surgical approach to the treatment of SUI that can be performed in a physician’s office or an outpatient center. Clearance was based on outcomes of a 12-month, multi-center clinical trial involving more than 170 women at 10 sites nationwide. Novasys said the study demonstrated the safety and efficacy of treatment with the Renessa System, with 76% of trial participants experiencing a reduction in daily incontinence episodes, 73% of women experiencing a reduction in leak severity, 67% reporting an improvement in their quality of life and 35% becoming continent. The Renessa treatment applies controlled heat to tissue targets within the lower urinary tract, denaturing collagen at multiple small treatment sites. Upon healing, these treated microscopic sites increase tissue resistance to involuntary leakage at times of increased intra-abdominal pressure, reducing or eliminating SUI episodes, the company said. Novasys said a physician can perform the procedure in about 20 minutes using a single-use transurethral probe. The procedure requires no bandages or dressings, and women can safely resume most activities immediately following treatment.

• Novo Nordisk (Princeton, New Jersey) said its GlucaGen HypoKit (glucagon [rDNA origin] for injection) is now available for use to treat severe hypoglycemic reactions that may occur in individuals who have insulin-dependent diabetes. The fully portable GlucaGen HypoKit is an emergency kit consisting of a syringe prefilled with sterile water for mixing and a vial of GlucaGen powder. The hard-shell, bright orange case provides product protection, does not require refrigeration, and is easily identifiable in an emergency. GlucaGen HypoKit also has comprehensive picture instructions for the administrator during an emergency situation and holds no danger of overdose. GlucaGen raises blood glucose by promoting the release of glucose from glycogen stores in the liver. Blood sugar levels increase within 10 minutes and peak at 30 minutes post peak at 30 minutes post injection.

• NuVasive (San Diego), a developer of minimally disruptive surgical treatments for the spine, reported results from a study conducted at Washington University (St. Louis), on the safety and reproducibility of its XLIF (eXtreme Lateral Interbody Fusion) minimally disruptive spine surgery procedure. The technique allows spine surgeons to achieve a direct lateral ap-proach to the patient’s intervertebral disc space thro-ugh the psoas muscle. Coupled with the company’s NeuroVision Nerve Avoidance System, the MaXcess Retraction System allows for maximum surgical access to the spine for addressing the pathology and inserting an interbody implant. This muscle splitting vs. cutting approach minimizes soft tissue dissection and disruption that often occurs during open surgery, and as a result reduces operative time and patient rehabilitation. The study included data from 145 XLIF surgeries performed by 20 U.S. surgeons on patients with varying lumbar spine disorders. The results showed the XLIF procedure provided safe and effective access to the disc space and resulted in minimal patient morbidity. The study showed that NeuroVision detected a nerve in or near the approach pathway in 46% of cases reported. Due to nerve detection, NuVasive’s instrument was then repositioned with a new trajectory and the disc safely accessed.

• Pegasus Biologics (Irvine, California) has secured 510(k) clearance for the OrthAdapt Bioimplant, the privately held company’s first product, which the company called “an intelligent, adaptable biologic scaffold.” The company secured clearance to use its bioimplants to reinforce compromised soft tissues in sports medicine, orthopedic and spine applications. Pegasus founder and president France Dixon Helfer said OrthAdapt “is a natural piece of equine pericardium, and we ... crosslink it to stabilize tissue and then we terminally sterilize it without changing any of the properties of the tissue.” She added: “It’s very, very adaptable, and that’s why it’s called OrthAdapt.” For example, she said, in sports medicine the company can repair injuries to the rotator, the Achilles tendon, biceps, or “any types of tendons that require a reconstructive material to reinforce” them. With spine defects, Helfer said there are “quite a few applications for us, including some of the ligaments of the spinal area that need a strong material that is completely biocompatible and sterile – that’s an area we’re just getting into.”

• Power3 Medical Products (The Woodlands, Texas) said it has converted two provisional patent applications by the filing of two utility patent applications with the U.S. Patent and Trademark Office for the company’s disease-specific biomarker discovery and disease-specific immunodiagnostic test designs. These patent applications are being filed to protect the platform technologies the company is using in conjunction with major research institutions in the Houston area to develop disease-specific diagnostic tests for neurodegenerative disease, breast cancer and drug resistance. The company said the applications are two of nine utility patents pending, 12 provisional patent applications and one issued patent owned or licensed by Power3, a proteomics company engaged in the discovery of protein footprints, pathways and mechanisms of diseases.

• Stereotaxis (St. Louis) reported that the first automated mapping of a patient’s left atrial heart chamber in conjunction with an atrial fibrillation ablation procedure was completed using the company’s Niobe Magnetic Navigation System. The automated mapping feature allowed Carlo Pappone, MD, PhD, of San Raffaele University Hospital (Milan, Italy), to move a magnetically navigated catheter to more than 100 places in the chamber of a beating heart in about 10 minutes, all with a touch of a button on the Niobe system. Stereotaxis said it believes that its Niobe system will be able to improve both the efficiency and efficacy of mapping procedures, while making the time required to perform the procedure more predictable. In addition, the consistent “soft-touch” contact with the heart wall unique to magnetically navigated catheters may reduce the risk of perforation while providing a more accurate map of the patient’s anatomy than can be achieved via manual navigation, according to the company.

• St. Jude Medical (St. Paul, Minnesota) has received FDA approval for the SJM Biocor and Biocor Supra family of stented tissue valves, marking the company’s first stented tissue heart valves in the U.S. market. “[This is our] first entry into this very important market,” George Fazio, president of St. Jude Medical’s Cardiac Surgery Division, told BBI, noting that the U.S. is “the largest tissue valve market in the world.” St. Jude already is one of the leaders in mechanical heart valves in the U.S., but it will be competing with Edwards Lifesciences (Irvine, California) and Medtronic (Minneapolis) in the stented tissue valve segment, which currently represents 60% of the U.S. market for heart valves, the company said. The SJM Biocor and Biocor Supra valves are designed to offer several unique ease-of-implant characteristics. The FlexFit stent, constructed of a flexible co-polymer material, “provides easy conformation to the annulus,” the company said. The valve also features the lowest anatomic profile (height) in the U.S. tissue valve market, according to St. Jude, minimizing aortic wall protrusion and left ventricular outflow tract obstruction in the mitral position.

• Suros Surgical Systems (Indianapolis), a manufacturer of minimally invasive biopsy and tissue excision products, said Health Canada approved commercial sale of the ATEC Breast Biopsy and Excision System for use in performing diagnostic breast biopsy and partial or complete removal of visible evidence of benign breast disease. The speed and ability of the ATEC system provides an effective alternative to open surgical biopsy. Tissue acquisition can be completed in 30 seconds, reducing total procedure time. The system is compatible with the three most common imaging modalities used in breast biopsy and offers diverse needle options. The ATEC system has been commercially available in the U.S. for more than four years.

Varian Medical Systems (Palo Alto, California) is introducing a new version of its Eclipse radiotherapy treatment planning software that substantially speeds up the process of planning complex radiotherapy treatments. The company said the new release incorporates new planning protocols and easy-to-use optimization tools that make it easier and faster to plan cancer treatments such as intensity-modulated radiotherapy and image-guided radiotherapy. The new Eclipse release incorporates a set of treatment plan templates that streamline the process of creating a personalized plan for each patient based on the patient's diagnostic images and the physician's dose prescriptions. Varian’s “AAA” dose calculation algorithm, which more accurately calculates radiation dose distributions in heterogeneous areas of the body such as the lung, also has been updated and is four times faster than the previous version. Eclipse now also incorporates a new automated segmentation tool that speeds up contouring, the process by which doctors separate diseased tissues from surrounding healthy organs on a set of 3-D diagnostic images in order to specify exactly where radiation dose levels are to be concentrated and which areas are to be protected. Another new feature, Remote Connect, enables clinicians to use a virtual private network and high-speed Internet connection to access their treatment planning systems remotely.

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