Medtronic AVE (Santa Rosa, California), a division of Medtronic (Minneapolis, Minnesota), has received CE-mark approval for its INX Neurovascular Stent. The company said that it is the only stent available on the market for use in the brain. The stent is indicated for the treatment of certain types of brain aneurysms, specifically intracranial, wide neck aneurysms. The INX provides an alternative treatment for patients who are considered high risk for surgery. The company says that the device is especially useful in cases where embolic coils might migrate into a blood vessel and cause a stroke.
Michael Williams, vice president and general manager of the Neurovascular Technologies Division at Medtronic AVE, said, "The difference between this neurovascular stent and other stents lies in the remarkable amount of flexibility that the INX possesses." Williams told Cardiovascular Device Update that this high degree of flexibility allows the device to be more easily threaded through the arteries of the head and neck, which have thinner walls than other arteries. Williams said that the INX is delivered, much like a coronary stent, through the groin at the femoral artery. A balloon attached at the end of the stent is then deployed at the target area to "trap" the aneurysm and cut off the supply of blood to the affected area. Due to the sensitivity of the arteries, the balloon used is also of a lower pressure.
The stent comes in 6 mm, 8 mm, 10 mm, 12 mm and 18 mm sizes, with prices ranging from $1,500 to $2,500.
Williams said that he expects U.S. approval by the end of 2001. "Since this is a new device, FDA will probably put it through more rigorous testing," Williams said. The stent was tested at seven clinical sights throughout the world prior to its CE mark. Medtronic AVE (formerly Arterial Vascular Engineering) also is looking for other applications for the INX stent. Studies are under way in Europe and the U.S. to use the INX for the treatment of intracranial, atherosclerotic lesions.
Elsewhere in the product pipeline:
American Biogenetic Sciences (Copiague, New York) said an article published in Circulation found that the blood-clotting protein fibrinogen seems to be a common pathway by which other risk factors cause heart disease. The study used the company's FDA-approved functional intact fibrinogen test in 2,632 patients in the Framingham Offspring Study, a continuation of the same study begun more than 50 years ago.
Amylin Pharmaceuticals (San Diego, California) completed its first Phase I study of AC3056, an oral drug being evaluated for prevention of restenosis following angioplasty and other procedures to open clogged arteries. The company said data were encouraging enough to warrant continuation of the Phase I program.
Angiogene (Montreal, Quebec, Canada) said in mid-October that it will be initiating a 20-patient Phase I/II clinical trial of its catheter-based delivery of the Oliglow radiopharmaceutical compound, designed to prevent restenosis following angioplasty. Oliglow consists of short DNA sequences that carry one atom of phosphorus 32.
ATS Medical (Minneapolis, Minnesota) received FDA clearance to sell the ATS Open Pivot Bileaflet Heart Valve for the treatment of valvular heart disease. The company said the ATS Open Pivot valve is the only clinical mechanical heart valve in the world with no cavities or recesses in the blood flow path, and is currently available in all developed markets of the world, in both aortic and mitral configurations. There are 21 sizes and valve configurations, with the approval covering the 15 most frequently used sizes. The company will continue to conduct clinical investigation on patients receiving valves of six sizes which have not yet been approved because they were used less frequently. ATS also plans to submit a premarket approval supplement on its Aortic Valved Graft.
Boston Medical Technologies (Wakefield, Massachusetts) has received extended clearance from the FDA to market its heart rate variability test called the Anscore Health Management System. The company said that extensive published clinical data reports that heart rate variability can be used as an indicator of autonomic nervous system dysfunction – damage to the autonomic nervous system – which is prevalent in patients with chronic diseases such as diabetes. Heart rate variability testing has traditionally been limited to research settings. Designed to be provided by the treating physician, this system assesses and documents a patient's heart rate variability in response to paced respiration and other controlled exercises. The session data is then transmitted through standard phone lines in the physician's office to the Anscore Processing Center, where analysts review each test. Boston Medical Technologies is developing office and hospital-based, non-invasive heart rate variability testing.
CardioTech International (Woburn, Massachusetts) has been issued U.S. patent No. 6,117,535, entitled "Biocompatible Devices," covering a method of reinforcing vascular grafts with polyurethane monofilaments that result in compliant, elastic and torque-resistant grafts. The invention is based on the properties of ChronoFlex biodurablepolycarbonate-based polyurethane elastomers. ChronoFlex filaments are inherently elastic, thus producing elastic small bore vascular grafts, compared to standard ePTFE grafts that are stiff and non-compliant. The filaments, 250 microns in diameter, are automatically applied to the outer surface of pre-formed microporous vascular grafts by a precision machine that applies a mist of solvent onto the monofilaments making them temporarily adhesive. Once adhered, the monofilaments can remain permanently attached or may be manually removed during use without damaging the structural integrity of the microporous graft.
Collateral Therapeutics (CTI; San Diego, California) said in mid-October that its strategic partner, Schering AG, is filing applications with six European regulatory agencies covering the beginning of clinical trials of CTI's Genvascor nonsurgical angiogenic gene therapy product candidate for treating peripheral vascular disease. The initiation of the European trials marks the second Collateral Therapeutics angiogenic gene therapy product to advance to human clinical testing. The Phase I/II trials are expected to enroll up to 130 patients at 10 major European medical centers, with the studies to begin before year-end. The product uses an adenovirus vector to delivery FGF-4, a growth factor gene that triggers the production of a protein which in turn causes new blood vessels to grow in ischemic regions of the leg. Its design is similar to Collateral's angiogenic gene therapy product for coronary artery disease
Cordis Neurovascular (CNV; Miami, Florida), a unit of Cordis, a Johnson & Johnson company, has received FDA clearance for the Trufill n-BCA Liquid Embolic System for presurgical embolization of cerebral arteriovenous malformations (AVMs) which are tangles of abnormally connecting arteries and veins. The product is an artificial embolization device comprised of Trufill n-Butyl Cyanoacrylate (n-BCA), Trufill Ethiodized Oil and Trufill Tantalum Powder which are combined into a mixture that is injected through a microcatheter to embolize AVMs prior to surgical resection. AVMs occur in less than 1% of the population but come with the risk of severe neurologic deficit or death if untreated. The product will be available soon and will be "compatible with Cordis Neurovascular delivery catheters, including our Regatta Flow Guided Infusion Catheter, as well as our Prowler and Transit microcatheters," the company said.
CryoLife (Kennesaw, Georgia), a maker of living human tissue implantable devices, stentless heart valves and surgical adhesives, has received the CE mark for its SynerGraft tissue-engineered pulmonary heart valves. SynerGraft technology uses a porcine heart valve which has been depopulated of its porcine cells, providing a collagen matrix that has the functionality of a human heart valve, with the potential to recellularize itself with the recipient's own cells. It is anticipated that the SynerGraft tissue engineered pulmonary heart valve will be used for right heart reconstruction, primarily in children. CryoLife also is developing other SynerGraft information and for use of SynerGraft pulmonary heart valves in human clinical trials for pediatric replacement.
D-Pharm Ltd. (Rehovot, Israel) said it has completed a Phase I safety assessment for DP-b99, its neuroprotective under development as a first-line therapy to improve outcome in stroke and traumatic brain injury patients and as a prophylactic agent to protect against neurological complications associated with open-heart surgeries. The company is initiating exploratory Phase II studies in Europe.
Genzyme Surgical Products (Cambridge, Massachusetts) initiated a clinical trial of a proprietary gene therapy designed to promote the growth of new blood vessels around blocked coronary arteries. The protocol for the trial was cleared earlier this year by the FDA, but Genzyme was awaiting review of the protocol by the NIH Recombinant DNA Advisory Committee before initiating the trial. The Phase I study will evaluate the use of a therapy based on an engineered form of the gene known as HIF-1a, which has been shown in preclinical studies to turn on the expression of many proteins associated with blood vessel formation.
Medtronic (Minneapolis, Minnesota) will begin a European clinical study of the new InSync III cardiac resynchronization system used to improve the heart's pumping capability. The InSync III system is designed to support device-based resynchronization and to incorporate "activation flexibility" allowing physicians to program and control the beating action of the right and left sides of the heart independently. It includes heart failure-specific diagnostic capabilities designed to monitor a patient's heart rate trends and activity levels. The new device is intended to build on technologies embodied in the company's first-generation InSync cardiac resynchronization system. It provides simultaneous beating action for right and left ventricles and for the second-generation InSync ICD device designed to add defibrillation capability and right ventricular-only sensing for patients at risk of sudden cardiac death. Clinical evaluation began last month when Daniel Gras, MD, a cardiologist at Clinique Georges Bizet (Paris), implanted the InSync III device to replace a conventional pacemaker in a 62-year-old man with a history of heart block. Gras reported that the patient was doing well with timing of left and right ventricles programmed separately. Physicians at selected European and Canadian medical centers are expected to participate in the clinical evaluations, implanting the system in appropriate patients. U.S. clinical evaluation is expected to begin later this year. The first- and second-generation cardiac resynchronization systems – the Medtronic InSync and InSync ICD devices respectively – are commercially available outside the U.S. but currently under clinical investigation in the U.S.
NeuroVasx (Plymouth, Minnesota) has received the CE mark for its Sub-MicroInfusion Catheter. The NeuroVasx Sub-MicroInfusion Catheter was previously cleared for sale in the U.S., Japan and Canada. NeuroVasx is a development-stage company that makes catheter and implant technologies to treat acute stroke, aneurysms and other cerebrovascular disorders.
Novoste (Norcross, Georgia) reported last month that it has received an "approvable" letter from the FDA for its Beta-Cath System. The Beta-Cath is an intracoronary radiation catheter system designed to treat patients who have recurrent coronary artery blockage within a previously placed stent. The letter comes less than 180 days after Novoste's submission of its premarket approval application in April, with the company winning a unanimous recommendation of approval for the system in September from the agency's Circulatory System Devices Advisory Committee. Issuance of an approvable letter means the FDA is prepared to approve the application, pending Novoste's compliance with specific final conditions. The key conditions are successful conclusion of a Good Manufacturing Practices audit, which is nearing completion, and finalizing printed labeling materials. Other conditions relate to finalizing protocols for post-market surveillance and user training, and responding to other information requests. William Hawkins, president and CEO of Novoste, said the company is "making good progress toward resolving the FDA's conditions," and is planning for product rollout at this month's annual conference of the American Heart Association in New Orleans, Louisiana.
St. Jude Medical (St. Paul, Minnesota) released its 8 Fr Angio-Seal Millennium Platform. The company says that the device incorporates several advanced features compared to current 8 Fr Angio-Seal products. The features in the Millennium Platform have been available in the U.S. in 6 Fr Angio-Seal devices since March. This is the second major product enhancement of the 8 Fr Angio-Seal since St. Jude Medical acquired the Angio-Seal business from Tyco International in March 1999. Angio-Seal vascular closure devices are used to seal arterial punctures created during cardiology procedures. Approximately 30% of the 7 million cardiac catheterization procedures performed each year are accomplished using an 8 Fr puncture in the femoral artery. The enhanced features of the Millennium Platform include a monofold sheath tip, user-friendly cap and sheath markers, new five-point collagen weave, redesigned anchor and enhanced suture delivery and release mechanisms. The closure device is indicated for use in interventional procedures where patients receive anti-coagulant therapies.
Zoll Medical (Burlington, Massachusetts), a maker of noninvasive cardiac resuscitation devices that provide pacing and defibrillation, has received 510(k) clearance from the FDA for Zoll M Series defibrillators with noninvasive blood pressure monitoring. The ability to monitor blood pressure non-invasively adds another important parameter to the M Series capabilities, according to the company.