CardioTech International (Woburn, Massachusetts) reported that the first three patients enrolled in the MyoLink peripheral graft clinical study passed the three-month follow-up point with functioning grafts and relief of pre-operative symptoms. Three months' implantation with no graft problems is a clinical milestone in this type of procedure. The patients were suffering from disabling leg pain and limited mobility. MyoLink grafts were implanted from the femoral artery to the popliteal artery. After the leg implants, the patients have returned to normal conditions, according to the company.
MyoLink allows the transmission of pulsatile blood flow through the bypass and into the distal vessels, a feature that permits its use in smaller diameters for critical limb ischemia and claudication, according to the company. In the U.S., critical limb ischemia is responsible for 55,000 amputations annually, mostly in diabetics. CardioTech estimates that development of a successful below-the-knee peripheral vascular graft could tap a world market estimated at over $350 million annually.
The company also said it has launched a program to develop a synthetic coronary artery bypass graft, a product which it estimates to have a potential market of $1.5 billion worldwide. At present, saphenous veins from the patient's own legs must be used as a bypass graft. The CardioTech graft, trade-named CardioPass, will be constructed of the firm's patented ChronoFlex polyurethane, shown to be biodurable after three years of canine implantation and biocompatible with human saphenous veins. CardioPasss provides a scaffold for seeding with endothelial cells, a blood-compatible surface tested at Virginia Commonwealth University (Richmond, Virginia). During clinical trials, the CardioPass graft will likely be used in patients whose saphenous veins are unavailable due to disease or previous use.
The company estimates up to 20% of the more than 900,000 CABG procedures done each year worldwide involve patients having few or no suitable native saphenous veins.
Elsewhere in the product pipeline:
Alexion Pharmaceuticals and Yale University School of Medicine (both New Haven, Connecticut) said scientists discovered that elevations in harmful complement activation in patients with congestive heart failure are associated with worse clinical symptoms and a reduced rate of event-free survival at six months. Alexion's C5 complement inhibitor humanized monoclonal antibody, 5G1.1, blocks the production of harmful complement components, the company said.
Alteon (Ramsey, New Jersey) said it initiated a Phase IIa trial of its novel therapeutic agent, ALT-711, which has shown potential to reverse age-related cardiovascular disease and restore the cardiovascular system to a more youthful state by cleaving pathological protein-glucose structures called Advanced Glycosylation End-product Crosslinks. The study will involve 72 men and women over age 50 whose cardiovascular systems show measurable stiffening due to aging and/or diabetes.
Avant Immunotherapeutics (Needham, Massachusetts) said the FDA granted orphan drug status to Avant's lead complement inhibitor, TP10, as a potential treatment to reduce the consequences of reperfusion injury and to improve post-operative outcomes in infants undergoing cardiac surgery.
Biocompatibles (Farnham, United Kingdom) has submitted the third module of its BiodivYsio stent premarket approval application to the FDA for U.S. market approval. Assuming a smooth regulatory review path, the stent line could be ready for launch in 3Q00. The BiodivYsio stents are already CE-marked and on the market in most European countries. The stents will be distributed in the U.S. by Abbott Laboratories (Abbott Park, Illinois) under the terms of a deal under which Abbott will become sole distributor in the U.S. for Biocompatibles' cardiovascular stents and also have rights for use of the company's patented phosphorylcholine coating on its own devices
Cardima's (Fremont, California) new guiding catheter for accessing, visualizing, and then delivering intravascular devices to the veins of a patient's heart was awarded a patent from the U.S. Patent and Trademark Office.
Centocor (Malvern, Pennsylvania) has introduced the first shielding needle for a fibrinolytic drug Retavase (reteplase), a heart attack treatment marketed exclusively in the U.S. Centocor will provide the shielding needles in all Retavase kits, effective May 2000. The needles feature a plastic sheath that covers the needle upon withdrawal from an intravenous line. Retavase is a clot-busting drug administered to heart attack patients via double-bolus injections
Collateral Therapeutics (San Diego, California) said that a new placebo-controlled preclinical study led by the company's chief scientist, H. Kirk Hammond, MD, and Associate Director of Research M. Dan McKirnan, PhD, found that intracoronary delivery of the human gene Fibroblast Growth Factor-4 (FGF-4) increased heart function and reduced the size of dilated hearts in the setting of heart failure. The research, published in Cardiac and Vascular Regeneration, indicates that FGF-4 gene therapy is useful in the treatment of heart failure. "These preclinical study findings are important because they could potentially provide important insights into the development of a new nonsurgical therapeutic option for patients with dilated heart failure," the company said. The technology covered under this study has been exclusively licensed to Collateral Therapeutics, which plans to develop a nonsurgical gene therapy using the FGF-4 gene for the treatment of patients with heart failure. Angiogenesis is a biological process that stimulates the growth of new blood vessels. Collateral Therapeutics also is using FGF-4 gene therapy to develop a treatment for patients with clinical coronary artery disease and recently announced positive preliminary results from a Phase I/II trial in patients with angina.
Computer Motion (Santa Barbara, California) reported completion of the world's first series of pediatric cardiac procedures using the company's ZEUS Robotic Surgical System. Francois Laborde, MD, PhD, chief of cardiac surgery at L'Institut Mutualiste Montsouris Chiosy (Paris), performed seven fully endoscopic closures of the patent ductus arteriosis with the ZEUS system, the company said. The procedures were performed entirely through three incisions, each only 0.2 inches long, eliminating the need for a 4-inch to 5-inch incision that would normally be used in this procedure Laborde reported that the patients, ranging from 7 months old to 24 months old, were recovering quickly. Yulun Wang, PhD, founder and chief technical officer of Computer Motion, said the procedure "marks a new application for our technology, which will provide significant benefits to patients, in this case young children."
CryoLife (Kennesaw, Georgia) has received FDA approval to expand the investigational device exemption (IDE) application for its BioGlue surgical adhesive human clinical study to include the use of BioGlue in vascular and selected cardiac repairs. BioGlue had been approved for use in an IDE clinical study as a surgical adjunct in the repair of type A aortic dissections, and the expanded study will assess the safety and effectiveness of BioGlue's ability to stop bleeding in cardiac and vascular procedures. The study will involve about 160 patients and is expected to be completed by year's end. BioGlue is distributed in 35 countries outside the U.S. for application in vascular and pulmonary repair.
Results of a preclinical Ventriculocoronary Artery Bypass (VCAB) revascularization procedure, developed by HeartStent (Minneapolis, Minnesota), have been published in the March 2000 edition of The Heart Surgery Forum. HeartStent's approach is to supply blood to a coronary artery directly from the left ventricle of the heart by placing a proprietary device through the ventricular wall and then into the coronary artery, thus eliminating the surgical procedure to harvest arteries or veins. John Schorgl, company president and CEO, said, "Acceptance of the HeartStent procedure by the rigorous standards of a peer review board substantiates our scientific approach and physician interest in our early pre-clinical results." The company reports having 10 issued or allowed U.S. and foreign patents covering the procedure and numerous patents pending.
IntraTherapeutics (St. Paul, Minnesota) has received FDA 510(k) clearance to market its IntraStent DoubleStrut LD biliary endoprosthesis, a balloon-expandable, stainless steel stent that features flexibility, strength, placement accuracy, and a diameter expansion range for large lumen procedures. It is available in lengths of 16 mm, 26 mm, 36 mm, 56 mm, and 76 mm each, with a diameter expansion range of 9mm to 12mm. John Erb, president of IntraTherapeutics, said the product "expands our product depth, and provides our physician customers with a large-diameter stent with excellent performance." It joins the company's IntraStent, IntraStent DoubleStrut, and IntraCoil line of stents
Matrix Therapeutics (Manchester, UK) has begun a clinical trial of DO2, a product for diagnosing cardiac hypertrophy, or enlargement of the heart, one of the key risk factors for cardiovascular failure. This is currently diagnosed using imaging techniques such as echocardiography and magnetic resonance imaging, which are time consuming and expensive. The test involves measuring the product of a gene which is active in the neonatal period when the heart is developing, repressed in adult life, and appears to be reactivated in the development of cardiac hypertrophy. Matrix said it believes such a diagnostic could be used to provide a regular, physician's office check-up for the onset of hypertrophy in patients being treated for hypertension. The study is designed to assess the relationship between cardiac mass index, as measured by an echocardiogram, and the level of the gene product in blood from patients with hypertension and a control group.
Possis Medical (Minneapolis, Minnesota) has received 510(k) clearance from the FDA for use of the AngioJet Rheolytic Thrombectomy System's LF140 catheter to treat thrombus in leg (peripheral) arteries. This clearance makes the AngioJet the first and only new-generation thrombectomy device with FDA-approved labeling for this indication. Possis said last month that marketing for the new indication would start immediately. The device is already approved for blood clot removal from coronary arteries, coronary bypass grafts, and AV dialysis access grafts. Possis Medical is involved in the mechanical thrombectomy market for treating blood clots in the cardiovascular, peripheral, and neurovascular markets. the AngioJet Rheolytic Thrombectomy System is marketed in the U.S. for blood clot removal from coronary arteries, coronary bypass grafts, AV dialysis access grafts, and now for peripheral arteries.
Somanetics (Troy, Michigan) reported that in an ongoing clinical study using the INVOS Cerebral Oximeter at the Semmes-Murphey Neurosurgical Clinic of Baptist Medical Center (Memphis, Tennessee) the Cerebral Oximeter reacted to brain blood oxygen saturation changes faster than electroencephalography (EEG) during carotid endarterectomy surgery. The initial clinical results of the study were published in the March issue of the Journal of Neurosurgery. Somanetics, in a report that calls the INVOS "the only patient monitoring system commercially available in the U.S. that noninvasively and continuously monitors changes in the regional oxygen saturation of the blood in the adult brain." Patients underwent carotid endarterectomy surgery in which both cerebral oximetry and EEG monitoring were used to monitor for low oxygen levels in the brain. The cerebral oximetry readings consistently revealed decreased brain blood oxygen saturation experienced by the patients before the EEG readings changed, usually by several minutes.
St. Jude Medical (St. Paul, Minnesota) reported the first implants of its Genesis system, a new device-based ventricular resynchronization system for the treatment of congestive heart failure (CHF) and suppression of atrial fibrillation (AFib). The Genesis system is comprised of the Frontier 3x2 electrical stimulation device, the Aescula LV Left-Heart Lead, and the Alliance Left-Heart Delivery System (LHDS). The Frontier 3x2 device and Aescula LV lead were implanted using the Alliance LHDS in a Class 4 heart failure patient and a Class 3 heart failure patient. Daniel Starks, president and CEO of St. Jude's Cardiac Rhythm Management unit, said the system helps to manage "several complex cardiac conditions that can be significantly worse when they occur together." The Frontier device and Aescula lead provide ventricular resynchronization therapy for the treatment of CHF, and the Frontier also incorporates St. Jude's Dynamic Atrial Overdrive algorithm for the suppression of AFib.
Vasomedical (Westbury, New York) reported that long-term results of enhanced external counterpulsation (EECP) therapy are similar to results reported in contemporary surgical bypass and angioplasty trials. These results come from a study, "Long-term prognosis of patients with angina treated with enhanced external counterpulsation: Five-year follow-up study," published in the April issue of Clinical Cardiology. The study tracked the occurrence of major adverse cardiovascular events in the first 33 patients with coronary artery disease treated with EECP therapy at the State University of New York Health Sciences Center (Stony Brook, New York). Responders to that therapy, as indicated by improvement in stress perfusion imaging, comprised 79% of the group, with 21% not responding. Subsequent major adverse cardiovascular events, including myocardial infarction, bypass surgery, angioplasty, and death, were significantly less frequent in the EECP therapy responder group than in the non-responder group. The five-year survival rate of the 33 noninvasively treated EECP patients in the study was 88%, similar to rates reported in contemporary surgical bypass and angioplasty trials, despite the fact that many of the EECP therapy patients had already failed revascularization attempts.