Novoste (Norcross, Georgia) said Wednesday it had received FDA approval to market its next-generation, smaller-diameter catheter system, the Beta-Cath 3.5F System, to treatin-stent restenosis. The new system is offered with both a 30 mm and 40 mm radiation source train and includes what Novoste described as "the smallest-diameter vascular brachytherapy catheter commercially available."The Beta-Cath 3.5F System can be used with a 6 Fr guide catheter and incorporates a proprietary "jacketed" small radiation source train. The company said that due to its lower profile, the 3.5F System will be able to treat areas unable to be addressed with its current Beta-Cath 5F System. Novoste said the smaller catheter diameter and multiple radiation lengths should allow the 3.5F system to be particularly useful in the treatment of in-stent restenosis.
Thomas Weldon, chairman and CEO, said the Beta-Cath 3.5F System "has been used clinically outside the U.S., where physician acceptance has been very positive due to its lower profile and compatibility with commonly used 6F guide catheter systems." He said that as of year-end, the Beta-Cath system had been installed in nearly 340 hospitals in the U.S.
Elsewhere in the product pipeline:
Biophan Technologies (Rochester, New York) filed four patent applications, offering improvements to the pacemaker field, including catheter design, electrode materials and hermetic sealing of components. These patents cover both traditional metal leads, used in today's pacemakers to connect the pacemaker to the heart, and the company's new fiber optic lead, which eliminates all the known causes of pacemaker safety issues associated with the use of MRI imaging. Current pacemakers are contraindicated by both the FDA and manufacturers for use with MRI equipment. Problems can occur when radio frequencies used in MRI encounter the wire lead connecting a pacemaker to the heart. Other patents involve extending the battery life of the fiber optic solution, which uses somewhat more energy than a wire solution. Biophan continues to work on extensions of its technology to other medical devices that are susceptible to MRI.
Boston Scientific (Natick, Massachusetts) reported the first U.S. human use of its FilterWire EX embolic protection device and Carotid Wallstent Monorail device, as part of its FDA-approved clinical trial designed to evaluate the benefits of stenting in conjunction with embolic protection to treat carotid artery disease. The procedure was performed at the Arizona Heart Institute and Foundation (Phoenix, Arizona). The trial will enroll as many as 775 patients at up to 40 U.S. sites. The FilterWire EX embolic protection device is a low-profile filter, mounted on a rapid exchange deployment system, designed to capture embolic debris that is released during a procedure to prevent it from traveling to the brain.
Cardiac Science (Irvine, California) received 510(k) clearance to market its Powerheart AED (automated external defibrillator), a public-access defibrillator for the emergency treatment of victims of sudden cardiac arrest. The Powerheart AED incorporates Cardiac Science's RHYTHMx technology, which powers its Powerheart CRM fully-automatic hospital bedside monitor-defibrillator. As a result, the company was granted FDA clearance for new indications including the elimination of the need for the rescuer to determine whether or not the cardiac arrest victim has a pulse prior to attaching the defibrillator device. Powerheart is also cleared for continuous monitoring of a conscious victim's heart rhythm after revival, protecting the victim against the reoccurrence of a post-resuscitation life-threatening arrhythmia, until hospital admittance. Cardiac Science develops AEDs and disposable defibrillator electrode pads that monitor and treat patients who suffer life-threatening heart rhythms.
COR Therapeutics (South San Francisco, California) said the Journal of the American Medical Association reported that one year following intracoronary stenting, patients who received Integrilin (eptifibatide) injection in addition to traditional care continued to benefit from a significant reduction in the combined incidence of death or heart attack. Integrilin helps prevent reocclusion of the stented artery by blocking certain receptors, known as GP IIb-IIIa, on platelets that are responsible for thrombus development. The publication reported that the combined incidence of death or heart attack was significantly reduced from 12.4% with placebo to 8.0% with Integrilin. A consistency of benefit was reported regardless of patient age, weight, sex, clinical condition, or presence or absence of diabetes.
Endocare (Irvine, California), a developer of diagnostic and treatment tools for cancer and other diseases, received 510(k) clearance from the FDA to market its Cryocare Surgical System for a minimally invasive thoracoscopic cardiac cryosurgery procedure to treat arrhythmia. The new clearance allows for a minimally invasive approach to replace, in many cases, what has historically been performed in an open surgical setting. Endocare in September 2001 formed a strategic alliance via a five-year exclusive global supply and market access agreement with CryoCath Technologies (Kirkland, Quebec), a leader in cryotherapy products to treat cardiovascular disease. The companies are developing a line of surgical probe systems to surgically treat cardiac arrhythmia in a minimally invasive manner.
Guidant (Indianapolis, Indiana) released its next-generation Axius Vacuum 2 Stabilizers for performing off-pump coronary artery bypass surgery, also called beating-heart surgery, which allows physicians to perform bypass surgery without stopping the heart and placing the patient on a heart-lung machine. The Axius Vacuum 2 Stabilizers are designed to stabilize the area of the heart where the blocked vessel is located and to allow physicians to graft that vessel without stopping the heart. When used with the new Axius Xpose 3, the system allows the surgeon to lift the heart and access vessels in the back without compromising the natural pumping action of the heart. The company also reported the U.S. and European launch of its Flextend pacing lead. The Flextend lead allows the physician to extend or retract a corkscrew-like tip, or helix, which then attaches to the heart.
Hemosol (Toronto, Ontario) received FDA notice to begin a clinical trial of its lead oxygen therapeutic, Hemolink (hemoglobin raffimer), in re-do cardiac bypass grafting (CABG) surgery. The two-armed study will investigate the efficacy of Hemolink in approximately 140 patients at more than 40 U.S. sites. All patients will undergo the same intraoperative autologous donation procedure, with either Hemolink or allogeneic red blood cells administered in response to transfusion triggers. The re-do study design is similar to an ongoing primary CABG study, which received FDA approval in November of 2001 and is now actively recruiting patients; both studies are expected to run concurrently and conclude in 2Q02. Data from the primary and re-do studies will be used to strengthen a pending application in the UK. Hemolink is designed to sustain life by providing immediate and safe oxygen delivery to vital organs and tissues in patients undergoing cardiac, orthopedic and other surgeries and chemotherapy.
Jomed (Beringen, Switzerland) said that its Solem GraftConnector, a distal sutureless vascular anastomosis device, was used during a bypass procedure that was completed in record time. During a live case transmitted from the University Hospital (Helsinki, Finland) to Miami, Florida, at the Cardiothoracic Techniques and Technologies conference, surgeons performed the open-chest, off-pump coronary artery bypass graft procedure using Solem. The mammary artery was taken down and connected to the right coronary artery. The anastomosis was done in under a minute. Solem is designed to complete fast distal sutureless vascular anastomosis, especially for coronary artery by-pass surgery during beating heart procedures. Efficacy evaluations in animal trials and in ongoing human trials confirm that sutureless anastomosis on a beating heart and off pump can regularly be completed in under a minute.
PharmaSonics (Sunnyvale, California) completed enrollment for its pivotal SWING and Euro-SPAH Intravascular Sonotherapy trials. Enrollment began in November 2000 and reached a goal of 800 SWING patients and 400 Euro-SPAH patients. Euro-SPAH results will be presented in September at the Transcatheter Cardiovascular Therapeutics symposium and the European Society of Cardiology congress. The SWING results, and the combined SWING/Euro-SPAH results, will be presented in November at the American Heart Association meeting. The trials are designed to establish the long-term safety and efficacy of the intravascular sonotherapy procedure to reduce the incidence of restenosis in patients with de novo stents in native coronary arteries. Euro-SPAH is the pivotal trial for Europe. SWING is one of two U.S. pivotal trials, along with the ongoing SPLASH trial, which is designed to establish the long-term safety and efficacy of sonotherapy to reduce the incidence of restenosis in patients treated for coronary in-stent restenosis.
Rheologics (Exton, Pennsylvania) concluded the preliminary clinical trial of one of the first research studies to use its Kensey Rheolog device. HELP (Heparin-induced Extracorporeal LDL-Precipitation), or LDL-Apheresis, is a process that reduces serum LDL-cholesterol by 65% in two hours for patients with a level greater than 200mg/dl and cardiovascular disease resistant to pharimcotherapy. The study was performed to evaluate the blood viscosity levels of high cholesterol patients during intervention treatment. It measures blood viscosity by enabling healthcare providers and researchers to test circulating, unadulterated blood. Rheologics focuses on the emerging field of hemorrheology – the study of the dynamics of blood flow and its impact on vascular-related diseases.
Rubicon Medical (Salt Lake City, Utah) completed the feasibility testing of its Embolic Filter, a device under development for protection against embolic events in coronary and peripheral stent procedures. The Rubicon Filter is used to protect vital organs during stent procedures, in which some of the plaque material that clings to the walls of the arteries can become dislodged. The Rubicon Filter acts as a tool, downstream from where a stent is placed, to capture this embolic material and to remove it from the bloodstream.
St. Jude Medical (St. Paul, Minnesota) launched the Angio-Seal STS Platform, its latest-generation vascular closure device. Offered in both 6 Fr and 8 Fr configurations, it is indicated for use in closing the femoral arterial puncture sites following diagnostic or interventional catheterization procedures. The STS Platform features a self-tightening suture, which eliminates the need for the post-placement spring used in previous Angio-Seal models. This feature allows the arterial closure procedure to be completed in the catheterization. The product also integrates Secure-Cap, which facilitates proper deployment through both tactile and audible confirmation during the closure process. The STS Platform incorporates additional visual markers to provide positive confirmation of a proper anchor-arteriotomy-collagen sandwich. The company also said researchers from Duke University Medical Center (Durham, North Carolina) reported positive data on St. Jude's Symmetry Bypass System Aortic Connector. The sutureless connector device, which received FDA clearance in May, was implanted 102 times in 53 patients by the clinicians. The bypass procedures were performed without a heart-lung machine, and no clamping of the aorta was required, two benefits of the connector device. Also, there was nearly a six-fold decrease in the incidence of cerebral microemboli, debris dislodged during bypass surgery.
Texas Biotechnology (Houston, Texas) said during last month's 27th International Stroke Conference in San Antonio, Texas, that clinical investigators presented a retrospective analysis suggesting positive clinical effects for Argatroban in acute ischemic stroke in patients with heparin-induced thrombocytopenia (HIT). Argatroban, a direct thrombin inhibitor anticoagulant, was approved in November 2000 by the FDA as an anticoagulant therapy for the prophylaxis or treatment of thrombosis in patients with HIT.
Vasomedical (Westbury, New York) reported positive results of a study published in the December 2001 issue of Cardiology. The trial studied 1,957 coronary artery disease patients, including a cohort of 548 patients with a history of congestive heart failure (CHF), enrolled in the International EECP Patient Registry (IEPR) who underwent enhanced external counterpulsation (EECP). The study found that nearly 70% of patients, both with and without a history of CHF, experienced an improvement in their functional angina class with fewer anginal attacks and reported an improved quality of life.
WorldHeart (Ottawa, Ontario) said the FDA approved its request to add 15 subjects to a clinical trial of its artificial heart pump as a long-term therapy. The company is investigating whether its Novacor left-ventricular assist device can provide a long-term option for patients with end-stage heart failure who are too sick to qualify for a heart transplant. The devices work by taking over the pumping function of the heart's left ventricle. The extended approval will increase WorldHeart's trial enrollment to 55 patients. The approval follows an October FDA approval to add 15 patients to the trial, which began in March 2000. WorldHeart's trial compares survival rates and quality of life between end-stage heart failure patients who receive the Novacor heart pump and those supported by available drug therapies. Novacor is commercially available as a bridge to transplantation in the U.S., Canada, Europe, and parts of Japan and China.
X Technologies (Tustin, California) received FDA approval to proceed with a pivotal clinical study for the FX miniRAIL Coronary Dilatation Catheter. The multicenter study is designed to evaluate the safety and clinical effectiveness of the product for dilating coronary stenoses and improving myocardial perfusion. The study is being conducted at nine centers in the U.S. and Europe. X Technologies received CE mark approval for the FX miniRAIL device in December, with European launch of the product now under way.