The Closed Loop Stimulation (CLS) technology developed by Biotronik (Berlin, Germany) enables pacemakers to monitor changes in cardiac contractility and to respond not only to exercise but also to other daily activities including stress-making situations. CLS has been cleared by the FDA following a multicenter clinical investigation evaluating its rate-adaptive performance in a dual-chamber pacemaker.
The company said CLS provides pacemaker patients with a heart-rate adaption based on their own cardiovascular control. The study results indicate that CLS responds to emotion, illness and the body's natural rhythms as well as to body motion and respiration during exercise, the parameter triggers for most current pacemakers.
Biotronik also has developed a new pacemaker capable of remote real-time monitoring, using phone signals to beam information from the pacemaker to the physician's office. A monitoring system permits customization of the pacemaker to automatically transmit a detailed cardiac report to the physician's office on a daily or weekly basis.
Elsewhere in the product pipeline:
Endovasc (Montgomery, Texas) said the U.S. Patent and Trademark Office issued a notice of allowance for its patent application filed in May 1999 covering the use of biodegradable surface coating and method for making the product. The technology used in this patent covers Endovasc's stent-coating process called Prostent, which coats vascular stents to prevent restenosis after vascular stenting. "Not only does it allow us to continue our work in the area of stent coating using our own pipeline of cardiovascular clinical products, but it will assist us as we continue our business development efforts to collaborate with other pharmaceutical companies," chairman and CEO David Summers said. The company continues preclinical work on stent coating using two of its clinical products: Liprostin, a liposomal formulation of Prostaglandin E-1, and Nicotine Receptor Agonist, an angiogenic agent.
Invivo (Pleasanton, California) said The New England Journal of Medicine published a study on coronary magnetic resonance angiography that could have positive implications for the MRI market served by its wholly owned subsidiary, Invivo Research. This study finds the use of coronary magnetic resonance angiography accurate in the detection of many types of coronary artery disease when compared to X-ray coronary angiography. Previously, Invivo reported its agreement with Philips Medical Systems (Best, the Netherlands) to develop an integrated MRI compatible patient vital signs monitoring system for use with Philips' new MRI scanner designed for coronary magnetic resonance angiography.
Jomed NV (Beringen, Switzerland) began two clinical studies on drug-coated stents, PRESENT (PREliminary Safety Evaluation of Nanoporous Tacrolimus eluting stents) and EVIDENT (Endo-Vascular Investigation Determining the Safety of a New Tacrolimus Eluting Stent Graft). PRESENT is a two-armed safety study. One group of patients is treated with Jomed's coronary FlexMaster stents coated with a new nanoporous ceramic coating that has shown anti-restenotic properties in animal studies. The other group receives the drug-eluting version of the ceramic-coated FlexMaster stent carrying a defined dose of Jomed's first-line anti-restenosis drug, Tacrolimus, licensed from Fujisawa Pharmaceuticals Ltd. (Osaka, Japan). EVIDENT evaluates the safety of a tacrolimus-eluting version of Jomed's coronary stent graft, which will be applied for treating patients suffering from saphenous vein graft stenosis.
Life Medical Sciences (Oceanport, New Jersey) received FDA approval to conduct a multicenter, feasibility clinical trial on its Repel-CV bioresorbable adhesion barrier. Repel-CV is designed to reduce the formation of adhesions scar tissue on the surface of the heart after open heart surgery. The clinical trial will assess the efficacy of Repel-CV in preventing or reducing adhesion formation in neonatal patients who require a staged series of open-heart surgical procedures, as well as provide additional data on the product's safety profile. The FDA approval was based, in part, on the favorable results from a multicenter clinical safety study previously conducted on adult patients undergoing open-heart surgical procedures.
Magna-Lab (Syosset, New York) reported that Massachusetts General Hospital (Boston, Massachusetts) will begin an animal study of the company's intra-vascular MRI catheter coil. The purpose is to further demonstrate the benefits of using the MRI catheter coil to obtain in vivo, high-resolution MR images of the coronary vessel walls. The product is threaded through a catheter and guidewire to the site of the atherosclerotic blockage. The images are intended to assist in the treatment of coronary artery disease by permitting the physician to assess the morphology (structure and form) and the chemistry of the atherosclerotic plaque, believed by some medical professionals to be a common precursor of heart attack and stroke. The first imaging is expected within the next few weeks, and the study is expected to continue for approximately four months.
Medtronic (Minneapolis, Minnesota) received FDA approval for its CareLink Monitor and software for remote patient management, allowing physicians to evaluate a patient with an implantable cardiac device over the Internet, without requiring the patient to leave home. CareLink is a medical information system that combines the patient's monitor, a web site for clinicians and a web site for cardiac device patients and their families or caregivers. The product initially will serve patients who have GEM II DR/VR implantable cardioverter-defibrillators (ICDs). However, the network is designed to support a wide range of implanted cardiac devices, including Medtronic's other ICDs, pacemakers, heart failure devices and monitoring/diagnostic devices as they become available following subsequent FDA approvals.
Novoste (Norcross, Georgia) said the first two patients were treated in its MOre patency with Beta In the Lower Extremity (MOBILE) trial on Dec. 28 at Rush Presbyterian-St. Luke's Medical Center (Chicago, Illinois). The MOBILE trial protocol will include more than 400 patients from 30 sites in North America and Europe. Patients will be randomized to receive either standard percutaneous catheter-based revascularization therapy followed by vascular brachytherapy or standard therapy alone. Enrollment is expected to be complete in the second half of the year. "We developed the Corona System to deliver Beta vascular brachytherapy to large 5 mm-8 mm vessels with a short (3 to 5 minute) single treatment time," said David Field, Novoste vice president of new technology.
Qmed (Laurence Harbor, New Jersey) and CHA Health (Lexington, Kentucky) said they have lowered the incidence of heart attack by 35.5% for the total CHA Health membership. In addition, they achieved major reductions in the utilization of invasive and other procedures related to coronary artery disease. QMed president and CEO Michael Cox said, "These total membership outcomes ... validate yet again the power of our disease management approach that emphasizes the key role of the physician in patient care." Qmed's Ohms CVD (On-Line Health Management System for Cardiovascular Disease) is an information technology that combines patient-specific prognosis and national standard therapeutic recommendations to primary care doctors, while incorporating process reports of expense and health outcomes for the managed care organization. CHA Health is a managed care organization with more than 140,000 members serving central and eastern Kentucky.
Radiance Medical Systems (Irvine, California) completed enrollment in the BRITE II (Beta Radiation to Reduce In-Stent Restenosis) pivotal clinical study. A total of 423 patients were enrolled in the study at 26 clinical sites in the U.S. and Europe. The multicenter, randomized BRITE II study was designed to support a pre-market approval filing with the FDA. The study is designed to determine the safety and effectiveness of the RDX Coronary Radiation Delivery System in patients who have had a coronary stent implanted and have returned to the hospital with in-stent restenosis. The follow-up period for these patients is nine months post procedure and is should be completed by 4Q02. Radiance develops radiation delivery catheters for use in the treatment of coronary and peripheral vascular systems to prevent restenosis following the interventional treatment of atherosclerosis.
St. Jude Medical (St. Paul, Minnesota) received premarket approval from the FDA for the Atlas family of implantable cardioverter defibrillators (ICD), which the company terms the world's most powerful rate-adaptive ICDs. Atlas ICDs offer high energy and small size without compromising charge times, longevity, or feature set flexibility. At 42 Joules stored/36 Joules delivered, the company said Atlas ICDs are the most powerful rate-adaptive ICDs available. Atlas is available in two models: a rate-adaptive DR model (V-240) 37 cc and 12 mm thin; and a rate-adaptive VR model (V-199) 36 cc and 12 mm thin. Full U.S. commercial release for the Atlas family is scheduled this month. Atlas marks the third family of rate-adaptive ICDs launched by St. Jude in the past 15 months. Over the next 12 months, the company plans three additional ICD introductions, subject to appropriate regulatory review.
Thoratec (Pleasanton, California) was notified that the FDA Circulatory System Devices Advisory Panel's review of the company's premarket approval supplement based on the REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) trial will occur March 4. The FDA said it would provide an expedited review of the company's PMA supplement application, which seeks approval to expand the intended use of the HeartMate VE LVAS (left ventricular assist system) based on the results of the REMATCH trial. If approved, the device would be available to provide long-term support for end-stage heart failure patients who are not eligible for heart transplantations. The device currently is approved for use as a bridge to heart transplant. Results released at last November's American Heart Association meeting demonstrated clinically meaningful survival benefits and improved quality of life for end-stage congestive heart failure patients supported by the HeartMate VE. Thoratec develops devices for circulatory support, vascular graft, blood coagulation and skin incision applications.
Vascular Architects (San Jose, California) received FDA 510(k) clearance to market the next-generation aSpire Covered Stent and Controlled Expansion Delivery System for use in treating tracheobronchial strictures. The aSpire Covered Stent is a spiral nitinol stent completely covered by a thin layer of ePTFE, which the company said provides greater lumen wall coverage than metallic stents, with no exposed metal. The stent is available in lengths of 2.5 cm, 5 cm and 10 cm, and in diameters from 6 mm to 12 mm. It is delivered using the company's Controlled Expansion delivery system, now available in a lower profile, with either 50 cm or 100 cm shafts, and is compatible with a .035 inch guidewire. The aSpire stent is being clinically evaluated in the U.S. under two investigational device exemptions for treatment of iliac and superficial femoral artery occlusions and of dysfunctional arterio-venous access grafts.