St. Jude Medical (St. Paul, Minnesota) received FDA approval to market the Identity pacemaker, the company's newest pacemaker product line. A limited U.S. launch of these devices has begun, with full U.S. market release scheduled for 1Q02. The first Identity pacemaker implant in the U.S. was performed in late November at Deborah Heart and Lung Center (Browns Mills, New Jersey) in a 48-year-old female patient who presented with symptomatic paroxysmal atrial fibrillation (AF), sick sinus syndrome and neurocardiogenic syncope.
The Identity family, which maintains St. Jude's AF Suppression Pacing Algorithm and the Beat-by-Beat AutoCapture Pacing System, expands the company's AFx feature set to include a comprehensive suite of arrhythmia diagnostics including dual-channel stored electrograms. AFx features are designed to help physicians better manage pacemaker patients suffering from AF.
Elsewhere in the product pipeline:
Angiogene (Montreal, Quebec) began enrolling patients into Beta-Impact, its Phase I/II trial for the prevention of restenosis following balloon angioplasty. This open-label trial is aimed at assessing the safety, tolerability and efficacy of delivering the Angiogene Oliglow radiotherapeutic compound locally into the coronary wall. Oliglow is a beta-emitter source that has demonstrated in preclinical studies optimal retention properties in the arterial wall, and has shown effectiveness in inhibiting smooth muscle cell proliferation, a key cause of restenosis.
CardioDynamics International (San Diego, California), a developer of Impedance Cardiography (ICG) technology and manufacturer of BioZ digital cardiac function monitoring systems, began the ED-IMPACT (Emergency Department IMPedance Cardiography-aided Assessment Changes Therapy) study at the Cleveland Clinic (Cleveland, Ohio) and the University of Mississippi Medical Center (Jackson, Mississippi). The trial will study BioZ's impact on diagnosis and treatment of patients who have shortness of breath in the emergency department, one of the primary causes for the over 95 million visits to emergency departments annually. Additionally, the study will allow comparison of BioZ ICG's parameters to other diagnostic test procedures, including chest x-ray, echocardiography and BNP (B-type Natriuretic Peptide), and how well the BioZ parameters predict hospital length of stay, charges, and mortality compared to the standard vital signs. The BioZ system is designed to assist in assessing, diagnosing and customizing drug therapy for patients with high blood pressure, heart failure and other cardiovascular diseases.
Cardiac Science (Irvine, California) was granted three additional U.S. patents related to its automatic external defibrillator (AED) products, covering the company's Powerheart technology, an external hospital monitor that provides continuous monitoring of heart rhythm to deliver a shock without the need for help from a hospital attendant. The patents include No. 6,301,502, which covers a defibrillation system that collects and downloads patient information to a central database; No. 6,304,780, covering the concept of an external module used to perform diagnostic testing of a defibrillator; and No. 6,321,113, covering proprietary methods for rapidly downloading of information stored in the memory of the device to a base station and transmission to another location without need to remove the AED from service. Cardiac Science has 10 additional patents pending.
CardioVasc (Menlo Park, California) received a CE mark from TUV Product Services for its first product, the NuVasc Stent Graft. The company's technology platform incorporates patented material surface strategies that bond various compounds and drugs to the device in order to reduce vessel inflammation and reduce restenosis. Interventional cardiologists will use the NuVasc Stent Graft to treat saphenous vein grafts that have failed after heart bypass surgery. An ePTFE sleeve treated with P-15, a patented cell adhesion peptide coating, covers the stent and serves to protect the plaque material from releasing into the bloodstream. P-15, developed by researchers at the University of California, San Francisco, promotes rapid endothelial cell growth on artificial surfaces. The company plans to initiate U.S. clinical trials this year.
Collateral Therapeutics (San Diego, California) highlighted results from a review article published in Circulation Research, a journal of the American Heart Association, that provides a review of safety data from clinical trials of cardiovascular gene therapy. The review article reports that clinical trials of cardiovascular gene therapy, whether using viral or nonviral vectors, have thus far disclosed no evidence indicative of inflammatory or other complications, including death, directly attributable to the vector used. Despite the fact that initial trials of cardiovascular gene therapy targeted patients with end-stage vascular disease, including critical limb ischemia and refractory myocardial ischemia, the mortality for patients enrolled in trials of cardiovascular gene therapy reported to date appears to compare favorably with mortality for similar groups of patients in contemporary controlled studies of medical or interventional therapies. Collateral Therapeutics is developing gene therapy products for the treatment of cardiovascular diseases.
Corvas International (San Diego, California) said results from a Phase IIa study show its anticoagulant rNAPc2 appears to be safe and well tolerated when administered to patients prior to elective percutaneous transluminal coronary angioplasty. The data also showed that, in contrast to standard therapy with heparin and aspirin alone, rNAPc2 effectively suppresses the formation of thrombin, a serine protease that is a factor in causing blood to clot.
CryoLife (Atlanta, Georgia), a developer of cryopreserved and tissue-engineered implantable heart valves, vascular and orthopedic reconstruction grafts and surgical adhesives, reported on a study by Baylor College of Medicine (Houston, Texas) demonstrating that a barrier of chlorhexidine gluconate gel, such as Surgilube, protected the phrenic nerve against acute injury from BioGlue surgical adhesive. The study concluded, "This simple protective strategy allows BioGlue to be safely applied to vessels near nerves." Kirby Black, PhD, senior vice president of research and development at CryoLife, said that the study "demonstrates the versatility of BioGlue surgical adhesive. To date, BioGlue has been used in various procedures involving more than 40,000 individuals with no reports of nerve damage from exposure to BioGlue." BioGlue surgical adhesive is approved as an adjunct for acute thoracic aortic dissections under HDE regulations in the U.S., is CE marked and approved in Canada and Australia for use in vascular and pulmonary sealing and repair.
CV Therapeutics (Palo Alto, California) said that in an open-label, dose-ranging Phase II trial in patients with atrial fibrillation or flutter, CVT-510 consistently reduced heart rate from baseline (p<0.05) without decreasing blood pressure. The company will now initiate a broad Phase IIb development program aimed at defining an optimized dosage regimen. Current trials for CVT-510 include a Phase III trial in patients with PSVT and Phase II trials in patients with atrial fibrillation. Clinical studies conducted with intravenous CVT-510 suggest that it may be possible to use intravenous CVT-510 for rapid intervention in the control of atrial arrhythmias without lowering blood pressure.
Edwards Lifesciences (Irvine, California) reported the first European implants of its next-generation Lifepath AAA Endovascular Graft system, a less-invasive option for treating abdominal aortic aneurysms (AAA), a condition that involves a weakening and ballooning of the wall of the aorta. Four patients were implanted with the device on its first day of availability, two each at centers in Belgium and Germany. The implants followed Edwards' receipt of CE mark clearance.
Esperion Therapeutics (Ann Arbor, Michigan) reported positive preliminary findings from a Phase IIa study of ETC-588, or LUV (large unilamellar vesicles), a novel biopharmaceutical currently in development for treatment of acute coronary syndromes. Esperion said it plans to continue clinical development of the candidate. Based on the results of the study, an optimal dosing schedule of every seven days has been defined for future study. Esperion also conducted a sub-study in this Phase IIa trial using MRI to assess its feasibility as an appropriate imaging modality. The company said the findings from this study establish the feasibility of using MRI to assess vascular structure of the carotid arteries, and this technology will be used in future studies of ETC-588 to assess a primary endpoint of rapid changes in plaque volume and composition.
Guidant (Indianapolis, Indiana) launched its Multi-Link Tristar coronary stent system in Japan. The product is available in low profiles and includes a broad range of sizes: diameters from 2.5 mm to 4 mm and lengths ranging from 8 mm to 28 mm.
Kensey Nash (Exton, Pennsylvania) began the PRIDE (PRotection during saphenous vein graft Intervention to prevent Distal Embolization) randomized trial for its TriActiv Distal Protection System. It will take place at up to 50 sites, enrolling up to 800 patients who will be randomized to either the TriActiv System or the traditional standard of care at each hospital. Training of the sites is ongoing and will continue over the next several months. The TriActiv System is designed to prevent heart attacks during the treatment of saphenous vein grafts (SVG) in patients who previously received coronary bypass surgery, but now have blockages in the grafts. The device incorporates three features to address the common problem of distal embolization: a balloon protection guidewire, a flush catheter and an extraction system to remove debris found in the grafts. Kensey Nash develops absorbable biomaterials products for the cardiology, orthopedics, drug and biologics delivery and wound care markets.
Novoste (Norcross, Georgia) received Canada Therapeutic Products Program approval to commercially market the Beta-Cath System with 30 mm, 40 mm and 60 mm radiation source train lengths and the B-Rail Delivery Catheter in Canada. Beta-Cath is designed to reduce the incidence of restenosis following percutaneous coronary interventional procedures. Novoste also reported that the Dante Pazzanese Institute of Cardiology (San Paulo, Brazil) completed its first Beta-Cath procedures.
Quinton (Bothell, Washington) released an electrocardiograph (ECG) unit, the QCG 740, a unit that acquires 10-second sections of ECG data and analyzes results for irregularities. The QCG 740 is the first product in a new family of Quinton cardiographs. The unit is designed for rapid input of patient demographics and acquisition of the resting ECG. The detection circuit digitizes at 10,000 samples per second to detect and exclude even the newest pacemaker signals to speed analysis, Quinton said. It also features a wireless option.
Radiance Medical Systems (Irvine, California) enrolled the first U.S. patients in its peripheral vascular clinical study, RAPID (Radiation After PTA Is Done). The three de novo lesion cases were completed at Rush Presbyterian Hospital (Chicago, Illinois); all involved the beta irradiation of a portion of the superficial femoral artery (SFA) using Radiance's RDX System. Radiance said it believes this was the first U.S. use of beta radiation to treat arterial stenosis in a peripheral vessel. Including European centers, a total of 14 patients have been treated under the RAPID protocol.
Somanetics (Troy, Michigan) received FDA clearance to market its CorRestore patch, an implant designed for use in cardiac repair and reconstruction, including surgical anterior ventricular endocardial restoration (SAVER), a treatment for patients with certain types of congestive heart failure. During SAVER, the surgeon restores the enlarged, poor functioning left ventricle to more normal size and function by inserting an implant, in most instances, or closing the defect directly. Somanetics expects the first implantation of the CorRestore patch this month, with a broader market launch in 2Q02.
Spectranetics (Colorado Springs, Colorado) completed enrollment of the PELA (Peripheral Excimer Laser Angioplasty) study, which tests the use of excimer laser angioplasty to treat blocked arteries in the upper leg. The randomized trial compares the safety and efficacy of the excimer laser with conventional balloon angioplasty, to balloon angioplasty alone, in treating total occlusions at least 10 centimeters long of the Superficial Femoral Artery, the thigh's main artery. Endpoints compare blood flow one year later at the site of the treatment. PELA includes a 12-month follow-up for all enrolled patients, with U.S. regulatory approval anticipated in 2003. The study was performed at 14 U.S. and five European hospitals. Spectranetics also said it is concluding its LARS (Laser Angioplasty for Restenosed Stents) trial at 138 patients in light of the recent FDA approval to market the company's products to clear out restenosed coronary stents prior to brachytherapy treatment. Spectranetics said it will continue to follow all 138 LARS patients through the study's nine-month follow-up period. The company's CVX-300 excimer laser is the only system approved by the FDA for multiple cardiovascular procedures, including coronary angioplasty and the removal of problematic pacemaker and defibrillator leads.
Thoratec (Pleasanton, California) received FDA approval of a supplement to its approved investigational device exemption (IDE) that enables the company to begin Phase II trials for its Aria CABG (Coronary Artery Bypass Graft). The trial is designed to test the safety and effectiveness of the device in coronary artery bypass surgery patients who have too few or no suitable vessels of their own. In Phase I, 20 patients were implanted at six centers. Each received one or more Aria grafts randomized against their own marginal quality veins as a control. The Phase II IDE filing contains a summary of clinical results from Phase I, including two-month MPI scans for 15 patients and six-month perfusion scans for 10 patients. Phase II will expand enrollment up to a total of 110 patients in up to 20 centers. Both the Aria and native control grafts will be evaluated by angiography at one year to determine patency of each graft. Thoratec develops devices for circulatory support, vascular graft, blood coagulation and skin incision applications.