Clinical and Industry News

S.M.A.R.T.® Stent Receives FDA Approval for Treatment of Iliac Artery Disease Cordis Endovascular has received U.S. Food and Drug Administration (FDA) approval for primary stenting of the iliac arteries with the S.M.A.R.T. ® Nitinol Stent and the S.M.A.R.T. ® CONTROL Nitinol Stent. A nine-month, multicenter, prospective randomized clinical trial documented the safety and efficacy of the S.M.A.R.T. Nitinol Stent System in treating iliac artery blockages. The study, known as CRISP (Cordis Randomized Iliac Stent Project), was sponsored by Cordis Endovascular, a division of Cordis Corporation, a Johnson & Johnson Company. The trial was designed to study equivalency to the WALLSTENT* Iliac Endoprosthesis, the control device in the CRISP Trial. The S.M.A.R.T. Nitinol Stent System is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries, with angiographic evidence of a patent profunda or superficial femoral artery. The CRISP study compared the performance of the S.M.A.R.T. Stent with that of the WALLSTENT* a stainless-steel, self-expanding stent. The goal was to confirm that the two stents offer comparable efficacy and safety. In all major variables evaluated, the S.M.A.R.T. Stent either matched or exceeded the performance of the WALLSTENT, said CRISP Investigator, Thomas O. McNamara, MD, Section Chief, Interventional Radiology, UCLA Department of Radiological Sciences, Los Angeles, CA. CRISP included 203 patients (102 randomized to treatment with the S.M.A.R.T. Stent, and 101 randomized to treatment with the WALLSTENT Iliac Endoprosthesis) who initially failed angioplasty. Primary clinical endpoints were evaluated at nine months post procedure with follow-up out to 12 months. Mean lesion length was 24.6 mm and 38% of lesions involved the external iliac artery. The study objective of equivalence was realized, with a composite endpoint of 6.9% for S.M.A.R.T. versus 5.9% for the comparison stent (p=ns). The nine-month endpoint is a composite of binary restenosis, death at less than 30 days, and target vessel revascularization. The study’s 12-month follow-up results show that the S.M.A.R.T. Stent and the control arm showed comparable efficacy in maintaining vessel patency (94.7% for the S.M.A.R.T. Stent vs 91.1% for the control arm; p=ns). Yet, the S.M.A.R.T. Stent was associated with a significantly higher acute procedural success rate (98.2% vs 87.5% for the comparison stent; pBoston Scientific Receives Date for FDA Panel Review of its TAXUS Drug-eluting Stent System Pre-market Application The U.S. Food and Drug Administration (FDA) has informed Boston Scientific Corporation that a November 20 special panel meeting will be held to review the Company’s Pre-Market Application (PMA) for its TAXUS Express2 paclitaxel-eluting coronary stent system. In June, the Company submitted the fifth and final module of its PMA to the FDA, starting the official regulatory review process. The TAXUS technology is Boston Scientific’s proprietary polymer-based, paclitaxel-eluting stent system for reducing coronary restenosis. Boston Scientific launched the TAXUS Express2 paclitaxel-eluting coronary stent system in Europe and other international markets in February. GE Medical Systems, St. Luke’s Episcopal Hospital and Medical Simulation Corp. to Provide Medical Training for Heart Procedures St. Luke’s to Become First SimSuite® Education Center in the Southern U.S. GE Medical Systems, St. Luke’s Episcopal Hospital and Medical Simulation Corp. have introduced a medical course designed to teach medical professionals the latest techniques in interventional cardiology. The course uses the SimSuite System, which combines haptics, or the science of touch, with real clinical scenarios and three-dimensional imagery of the heart. The course will be offered at the SimSuite Center at St. Luke’s in Houston, which is the first training center for the GE Cardiology Master Series, and the first top-rated heart center in the U.S. to have the SimSuite System. The SimSuite System teaches medical professionals the latest techniques used in minimally invasive cardiovascular and endovascular procedures, as well as critical care and emergency medicine. The SimSuite Education Center at St. Luke’s opens this fall. The two-day SimSuite course is part of a collection of clinical training courses called the GE Cardiology Masters Series - a program that provides cardiologists and technologists with an avenue for learning the latest techniques in interventional cardiology. The SimSuite System helps medical professionals learn and refine new procedures using the latest imaging technologies and medical devices. Participants are trained in a risk-free setting using a simulated patient, known as Simantha. St. Luke’s Episcopal Hospital has one of the largest cath labs in the U.S., performing more than 12,000 procedures each year. Medical institutions across the U.S. are opening SimSuite Centers for a number of reasons, including reinforcing quality standards, emphasizing a commitment to patient safety, recruiting and retaining staff, and maintaining guideline-driven consistency for medical training. SimSuite Centers are also located in California, Washington, and Pennsylvania. Several other SimSuite Centers are scheduled to open this year. Results of CADILLAC Analysis Show Efficacy for Abciximab in AMI Treatment improved 30-day event free rates A secondary analysis of the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) Trial showed that adding ReoPro (abciximab) during percutaneous coronary intervention (PCI) significantly improved 30-day event-free rates for the composite endpoint defined in the study. The composite endpoint was made up of death, myocardial infarction, ischemia-driven target-vessel revascularization, and disabling stroke. CADILLAC is the largest trial to evaluate antithrombotic therapies in primary PCI to date, and confirms and clarifies the early efficacy of abciximab therapy during primary PCI for reducing early ischemic adverse events, said David Kandzari, MD, assistant professor, division of cardiology, Duke Clinical Research Institute. Researchers concluded that when ReoPro was started immediately before primary PCI in acute heart attack patients, the likelihood of freedom from ischemic adverse outcomes at 30 days was improved. They also showed that the predominant effect of ReoPro was in reducing ischemia-driven target vessel revascularization or TVR, abrupt vessel closure and subacute thrombosis over the short term. Specific results included: ReoPro treatment was associated with a significant reduction in the composite end point of death, heart attack, ischemia-driven TVR, or disabling stroke at 30 days (4.6 percent vs. 7.0 percent; relative risk, 0.65; 95 percent CI, 0.46 to 0.93; p=0.01; relative reduction 34 percent.) ReoPro treatment, when combined with PCI, also significantly reduced subacute thrombosis, or clotting of the vessel leading to vessel closure. At 30 days the incidence was 1.5 percent for the control group vs. 0.4 percent for the ReoPro-treated group; relative risk, 0.26; 95 percent CI, 0.09 to 0.78; p=0.01. Rates of the composite endpoints at 12 months did not differ significantly (18.4 percent for control group vs. 16.9 percent for ReoPro-treated group; relative risk, 0.92; 95 percent CI, 0.76 to 1.10; p=0.29.) The CADILLAC trial was a randomized, open-label multi-center study involving 2,082 patients that examined the efficacy and safety of ReoPro in primary PCI for acute heart attacks. As a prespecified secondary analysis of the trial, researchers compared early and late outcomes by ReoPro assignment among patients randomized in an open-label, 2-by-2 factorial-design trial of primary stenting versus angioplasty and ReoPro treatment (1,052 patients) versus no ReoPro treatment (1,030 patients). Nanobac Pharmaceuticals Announces New Research Study Evaluating Nanobacterial Endotoxin in Patients Undergoing Coronary Angioplasty Nanobac Pharmaceuticals, Inc., announces approval of their Percutaneous Coronary Intervention (PCI) angioplasty research protocol by the Western Independent Review Board (WIRB(R), Seattle, WA). The Multi-Center PCI Study will be coordinated by the NanobacLabs Research Institute (Tampa, FL), the research subsidiary of Nanobac Pharmaceuticals, Inc., and will involve cardiologists at the University of Florida at Jacksonville, and Miami Heart Center. The PCI study is being conducted to evaluate the presence of nanobacterial endotoxin, antigen and antibodies in patients undergoing cardiac catheterization and coronary artery angioplasty intervention. It is Nanobac’s theory that the calcification in coronary artery plaque is actually calcified Nanobacterial infection within the plaque. Nanobacteria have been isolated and cultured from atherosclerotic plaque and have the unique capacity to cause calcification and inflammation in tissues. Nanobac researchers want to answer: Does the coronary angioplasty balloon smash calcified Nanobacteria dwelling in coronary plaque? Does angioplasty cause a release of Nanobacterial endotoxin leading to inflammation and swelling in the operated coronary artery? By testing blood samples for Nanobacteria before, during and after PCI angioplasty, Nanobac hopes to answer these questions. If the Nanobac theory is correct, nanobiotic® treatment before coronary intervention procedures may be able to decrease the incidence of restenosis (early closure) of coronary arteries after PCI angioplasty and/or coronary stent placement. The study will encompass 200 patients and is designed to conclude in several months. TopSpin Medical Announces the Initiation of First-In-Man Clinical Trial of Intravascular MRI Catheter for the Coronary Arteries TopSpin Medical Inc. announced the initiation of its First In Man clinical trial: TOP IMAGE: CORONARY, at two sites in Germany; The Universitatskliniken des Saarlandes in Homburg (Saarland) with Dr. Benno Hennen and the Herzzemtrum in Siegburg with Professor Eberhard Grube. TopSpin Medical has developed a technology for a miniature, portable imaging probe containing all the magnetic field sources to perform local MRI with no external magnets. The primary application developed by TopSpin is high-resolution imaging of coronary artery walls during cardiac catheterization by a single-use, IntraVascular MRI (IVMRI) catheter. The IVMRI catheter is intended to be used for the detection of unstable lesions in high-risk patients by giving interventional cardiologists a tool for identification of lipid laden regions of the vascular wall(a). The IVMRI catheter is designed to be free of motion artefacts problems related to cardiac MRI, since there is no relative motion between the catheter and the artery. Following the first clinical cases, Dr. Hennen commented, For years we have known that MRI is probably the best imaging modality for characterization of lesion composition. However, it was just unrealistic to have to send every patient for an MRI procedure. We now just put the miniature IVMRI catheter into the patient and get an image on the spot. Erez Golan, President & CEO of TopSpin Medical, noted, We have plans to test several MRI contrast agents to see whether the IVMRI catheter has the potential to identify regions of inflammation.(a) (a) Caution: TopSpin IVMRI system is not available for sale in the US. Currently conducting clinical trials to evaluate safety and efficacy. Onset Medical Receives FDA Go-Ahead For Cardiovascular Access Device Onset Medical Corp. announced that the Food and Drug Administration (FDA) has granted it clearance to begin marketing the company’s Pathway Percutaneous Access device in the U.S. for cardiovascular applications. The initial clinical application for the Pathway device is to provide easier and quicker access to perform percutaneous cardiovascular procedures with less trauma and damage to the vasculature and surrounding body tissues. There are approximately 2 million percutaneous cardiovascular procedures annually in the United States. The Pathway device is a new and different approach to percutaneous access technology. Thus far, early in vivo studies have shown that the Pathway Access Technology can allow the physician to achieve access to the vasculature quicker, easier and with less trauma to the body than with conventional non-surgical access approaches. Onset will now perform a comparative clinical trial to prove the clinical superiority of the Pathway Access Technology versus current, conventional access technology offered by a number of large medical technology firms.

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