Implant Sciences (Wakefield, Massachusetts), a developer of products for the interventional cardiology, radiation oncology, and orthopedic markets, said it has started its preclinical evaluation of radioactive coronary stents with multiple radioisotopes, using a porcine model in collaboration with the Cleveland Clinic Foundation (Cleveland, Ohio).
The preclinical studies at the Cleveland Clinic were launched in early June and were scheduled for evaluation this month. The goal of the study is to test the efficacy of the company's stent design, which contains Phosphorous-32 on the stent body with a spike of Palladium-103 activity at each end. The Palladium-103 provides additional radiation treatment beyond the end of the stent to address the "candy wrapper" effect observed in earlier clinical trials by others using only Phosphorous-32. The trial is being supported in part by a Phase I grant from the National Heart Lung & Blood Institute of the National Institutes of Health (NIH; Bethesda, Maryland).
Dr. Anthony Armini, president and CEO of Implant Sciences, said the most important feature of the trial is the even distribution of radiation, "using one isotope and then using a longer-range isotope at the ends to deliver radiation that affects the artery beyond the stent ends."
Implant Sciences has developed proprietary ion implantation equipment and processes that can accelerate and embed radioactive atoms into the surface of a metal stent. The company holds four issued and three pending patents on this technology for implanting coronary stents with a therapeutic dose of radioactivity to reduce restenosis.
Elsewhere in the product pipeline:
Acuson (Mountain View, California) said it has begun shipping its new Cypress Echocardiography System in North America. Weighing less than 20 pounds, the system offers applications in echocardiography ultrasound exams, including integrated stress echo. "The Cypress system is a state-of-the-art scanner because it incorporates harmonic 2-D imaging, digital image output with network capabilities, integrated stress echo, color Doppler and spectral Doppler," said Karl Schwarz, MD, director of the echocardiography laboratory and mobile cardiovascular imaging service at the University of Rochester Medical Center (Rochester, New York). Like Acuson's Sequoia and Aspen ultrasound platforms, the Cypress system features the DICOM communications standard embedded in the system, plus internal digital disc capacity for storing patient studies in high-resolution digital format. It can therefore connect with both the company's KinetDx PACS Solution and other DICOM networks.
Amylin Pharmaceuticals (San Diego, California) said it initiated the first Phase I trial for its drug candidate, AC3056, to target the prevention of restenosis following angioplasty and other procedures to open clogged arteries, as well as the treatment of atherosclerosis.
Boston Scientific (Natick, Massachusetts) has received CE mark approval of its GDC Tri-Span Coil, used to treat complex brain aneurysms and featuring a design that permits treatment of difficult shapes and sizes of aneurysms by helping to contain other GDC (Guglielmi Detachable Coil) coils within the aneurysm sac. Placed at the aneurysm opening, the GDC Tri-Span Coil acts as a scaffold to contain subsequently placed GDC coils. More than 112,000 patients will be diagnosed with a brain aneurysm this year. GDC coils are designed to reduce the likelihood of an aneurysm rupturing and causing a stroke and offer an alternative to craniotomy for repair of their brain aneurysms, a procedure requiring removal of a portion of the skull and a long hospital stay.
CardioTech International (Woburn, Massachusetts) said that a U.S. patent titled "Hydrophilic and Hydrophobic Polyurethane and Uses Thereof" was granted to Dr. Murray Reich of its Tyndale-Plains Hunter subsidiary. The patent covers a polyurethane for the manufacture of lubricious surface coatings, blood-compatible surfaces, controlled delivery systems, and personal care products. Tyndale-Plains Hunter is a leader in the production of hydrophilic polyurethanes, used by CardioTech to produce long-term implantable devices. CardioTech makes polyurethane-based vascular graft devices for treating last-stage cardiovascular disease.
Centocor (Malvern, Pennsylvania) said that new data from the ADMIRAL (Abciximab before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long-term Follow-up) study suggest significantly better clinical outcomes for patients undergoing primary stenting in acute myocardial infarction (AMI) when treated with ReoPro. The trial showed that patients undergoing percutaneous transluminal coronary angioplasty and primary coronary stent implantation who were treated with ReoPro had a reduced risk of death, improved coronary artery patency, and improvement of global left ventricular function at 24 hours. The six-month data were presented at the Paris Course of Revascularization. ADMIRAL is a double-blind, placebo controlled, multicenter trial of 300 AMI patients undertaken in 28 centers across France. ReoPro is marketed in Europe by Eli Lilly (Indianapolis, Indiana). In other news, Centocor said a pilot study found that ReoPro prevents the aggregation of platelets in patients undergoing coronary interventions and has shown statistically significant mortality benefit, while Retavase breaks up existing blood clots that can cause heart attacks. The study confirms earlier research designed to evaluate the clinical benefits of using an experimental regimen combining two currently available drugs. A total of 61% of patients treated with ReoPro plus half the standard dose of Retavase, and 60 units per kilogram of heparin, achieved normal coronary artery blood flow within 60 to 90 minutes. By comparison, 47% who received a full dose of Retavase and 70 units per kilogram of heparin achieved a normal flow. The results were published in the June 20 issue of Circulation.
Corgenix Medical (Denver, Colorado) said it has received FDA clearance to begin marketing another new test kit for the laboratory diagnosis and risk assessment of blood clotting disorders. The kit detects IgA antibodies to phosphatidylserine, with high levels of these antibodies reported in patients with antiphospholipid syndrome and characterized by recurrent thrombosis, thrombocytopenia, and fetal loss. This test complements two Corgenix products already FDA-cleared, the IgG and the IgM anti-phosphatidylserine test kits. Two additional test kits to detect IgG and IgM antibodies to prothrombin have recently been submitted to the FDA. Corgenix develops diagnostic test kits for vascular diseases and immunological disorders.
Corvas International (San Diego, California) said enrollment has been completed in the Phase II dose-ranging trial of its injectable anticoagulant, rNAPc2, for the prevention of deep vein thrombosis in orthopedic surgery patients. Preliminary analysis of the data indicates that rNAPc2 meets efficacy and safety expectations when compared to a contemporary historical control with low-molecular-weight heparin. The fully analyzed data will be released later this year.
Edwards Lifesciences (Irvine, California) reported receiving FDA 510(k) clearance to begin selling its Thrombex PMT (Percutaneous Mechanical Thrombectomy) System, a device for removing blood clots from the access grafts of hemodialysis patients. The system is a self-contained, disposable device using a motor-driven catheter and vacuum source to break up and remove blood clots from the patient's hemodialysis graft. A rotating helical screw at the end of the catheter reduces thrombi into tiny fragments, which are evacuated through the catheter into an attached collection container. It features a 6 Fr catheter with a braided-shaft design and is compatible with a 0.018-inch guide wire for improved insertion. Michael Mussallem, chairman and CEO of Edwards, said the system "is designed to be minimally invasive, making the procedure more comfortable for the patient. It's also easy for the clinician to use." The Thrombex PMT System is part of Edwards Lifesciences' family of vascular products that includes the Fogarty line of Arterial Embolectomy, guidewire-compatible Thru-Lumen Embolectomy, Adherent Clot and Graft Thrombectomy catheters.
ELA Medical (Paris) reported European commercial release of its Stelid II steroid-eluting, straight tined pacing lead. The leads feature a thin lead body which can be inserted through an 8 Fr introducer (less than 2.65 mm), facilitating access to small veins or insertion of two leads into the same vein. The lead's soft-tine fixation system retracts along the lead body for easier venous passage. The small size of the electrode's active surface creates higher impedance (i.e. greater current density) at the electrode/myocardial interface and hence reduces pacing thresholds, allowing programming of lower pacemaker output settings. The steroid-eluting tip of the lead decreases tissue inflammation and reduces the energy requirements for pacing, prolonging the service life of the pacemaker battery.
Endocardial Solutions (Minneapolis/St. Paul, Minnesota) reported receiving FDA clearance for an upgraded version of its Clarity software product for use in the EnSite 3000 System for diagnostic mapping of complex arrhythmias in the right atrium of the heart. The software is designed to simplify use of the EnSite 3000 System and cut training time for hospital staff. "The FDA's decision allows us to proceed with U.S. launch of Clarity several months ahead of schedule," said Jim Bullock, president and chief executive officer. Through a distribution agreement with Medtronic (Minneapolis, Minnesota), the EnSite 3000 System and catheter have been available to electrophysiologists in Europe since 2Q98.
Endovasc (Montgomery, Texas) reported fulfilling investigational new drug application requirements for Liprostin (prostaglandin E1), a liposome formulation of a naturally occurring vasodilating hormone. The drug will first be used to treat patients with critical limb ischemia, a $300 million market CEO David Summers called the "tip of the iceberg" for the product, which also has potential applications in coronary and peripheral restenosis, myocardial infarct salvage, and liver disease.
Forbes Medi-Tech (Vancouver, British Columbia, Canada) said results of a 12-week preclinical study of FM-VP4 show the compound reduces cholesterol levels by 75% and decreases blood fat levels by 44%. The compound was tested for effects when administered orally on lipid metabolism in apolipoprotein E-deficient mice.
GE Medical Systems (Waukesha, Wisconsin) unveiled its Vivid FiVe cardiovascular ultrasound system, which it calls the first ultrasound system to offer the new Tissue Tracking myocardial tissue visualization technique. Tissue Tracking is a real-time visualization tool for diagnosis and monitoring of coronary artery disease. Omar Ishrak, vice president and general manager of ultrasound for GE Medical Systems, said the system "captures cardiovascular images digitally, with exceptional speed, which allows cardiac function to be presented with more clarity than ever before." The new Vivid FiVe features 4-D Imaging; Tissue Tracking; and Contrast Imaging with real-time myocardial contrast. Tissue Tracking aids clinicians by providing better visualization of the regional wall motion of the heart, and 4-D imaging is a post-exam tool allowing clinicians to apply raw, 2-D digital data to construct a 4-D model of the entire cardiac function.
IntraTherapeutics (St. Paul, Minnesota), a developer of systems used to treat peripheral vascular disease and non-vascular obstructions, has received FDA 510(k) clearance to market its IntraStent DoubleStrut XS (Extra Support) biliary endoprosthesis for the treatment of malignant biliary strictures. The device is a balloon-expandable, stainless steel stent featuring improved radial strength and flexibility using a cell design applicable for challenging clinical procedures requiring enhanced radial strength. It is available in lengths of 12 mm and 17 mm, each with a diameter expansion range of 4 mm to 8 mm. The stent is in a U.S. investigational device exemption trial to determine its safety and effectiveness in treating severe renovascular hypertension due to renal artery stenosis or occlusion.
Progen Industries (Brisbane, Australia) said its compound, PI-88, will move into Phase II cardiovascular trials. The trials will test the product in preventing blood clots in thromboembolic diseases and angioplasty-induced restenosis. The company expects to begin the trials in 2001.
Somanetics (Troy, Michigan) said that a 156-patient study by the Weill Medical College (New York) of Cornell University demonstrated that cardiac surgery patients with low regional brain blood oxygen saturation before surgery, as monitored by the company's INVOS Cerebral Oximeter, are more likely to suffer post-operative frontal lobe and cognitive dysfunction after their surgery than patients with higher brain oxygen saturation before surgery. The study also demonstrated that low regional brain blood oxygen saturation before cardiac surgery is associated with prolonged intensive care unit and hospital stays. The study was presented by Fun-Sun Yao, MD, professor of anesthesia at Cornell University, at the Society of Cardiovascular Anesthesiologists' annual meeting.
Sonus Pharmaceuticals (Bothell, Washington) said the FDA has accepted as complete for review the company's response to the agency's March 2000 action letter on its first product, EchoGen (perflenapent injectable emulsion), an ultrasound contrast agent used in echocardiography to improve the assessment of the left ventricle. The March letter requested a reanalysis of certain data and follows an "approvable" letter received by the company in April 1999. The FDA has indicated that it will complete its review of Sonus's response by the end of October. Michael Martino, company president and CEO, said, "We had hoped that the FDA would assign a shorter review time for our response. However, we believe that we have addressed the issues raised by the FDA in the March letter, and we intend to work closely with the agency in its review of our response. We continue to believe in the opportunities for EchoGen and FDA approval remains a key objective."
St. Jude Medical (St. Paul, Minnesota) reported European launch of its advanced TVL-ADX lead, designed to be used with implantable cardioverter defibrillators (ICDs). Available in the U.S. since March, the lead uses the company's Tendril DX cardiac pacing lead technology for bipolar configuration for precise sensing, an extendable/retractable helix for active fixation in the ventricle, and steroid elution for reduced inflammation and low chronic pacing thresholds. True bipolar designs, like the TVL-ADX lead, use a small ring electrode instead of the shock coil, which may improve sensing performance. It also features a reservoir at the tip that slowly releases small quantities of a steroid that may reduce the energy requirements for stimulation, and it incorporates the company's Fast-Pass coating that makes the lead highly lubricious. St. Jude also reported U.S. release of its Fast-CathDuo line of Swartz Guiding Introducers that provide access into the left atrium of the heart through the intra-atrial septum, facilitating the simultaneous deployment of multiple diagnostic electrophysiology catheters. Fast-Cath Duo guiding introducers assist in the mapping of various left atrial based arrhythmias, including localization of focally initiated paroxysmal atrial fibrillation. The company also received CE mark approval for the Aortic Clip designed to facilitate rapid, simple and reproducible anastomoses for use in coronary artery by-pass graft (CABG) surgery. More than 700,000 CABG procedures are performed annually worldwide. The Aortic Clip was developed by St. Jude's Cardiovascular Group, formerly Vascular Science. The company said it plans a controlled market release of the Aortic Clip in several cardiac surgery centers throughout Europe this summer and fall.
Sulzer Medica (Winterthur, Switzerland) reported the first human implants of its latest-generation Anaconda bifurcated device for the treatment of abdominal aortic aneurysms. The implants are part of a larger clinical trial designed to evaluate the safety and performance of the Anaconda and its delivery system to achieve the CE mark. Anaconda is used in endovascular aneurysm repair, a less invasive procedure in which the graft is introduced through an artery in the groin and which is then guided to the defect under fluoroscopic control. The Anaconda features a ring stent design intended to prevent kinking as the aneurysm morphology changes. In addition, the legs, extending into the two arteries of the lower extremities, have a corrugated geometry, which gives the size adaptability inherent in conventional "open repair" vascular grafts with the added benefit of crush resistance.