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August 29, 2006 August 29 - September 4 August 29th: Biowave Corporation Announces 510(k) Clearance of Its DEEPWAVE(R) Percutaneous Neuromodulation Pain Therapy System Biowave Corporation announces that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its DEEPWAVE® Percutaneous Neuromodulation Pain Therapy system. The DEEPWAVE® system uses a patented percutaneous electrode array (PEA) to facilitate delivery of electronic signals through the skin and into deep tissue encompassing the pain site, thereby blocking the transmission of chronic, acute or post-operative musculoskeletal pain. The PEA is a single-use disposable device comprised of 1014 microneedles in a 2.5-inch diameter patch that is applied to the patient for a 30-minute treatment. PEAs are comfortable for the patient and feel similar to placing sandpaper or Velcro on the skin. Treatment using the DEEPWAVE® system may replace traditional first courses of action such as prescribing opiates, NSAIDs and physical therapy and is used prior to more invasive courses of action including injection therapies and surgery. Biowave will distribute its DEEPWAVE® professional device first to specialty physicians, including pain management specialists, spine surgeons and sports medicine surgeons for treating patients with chronic, acute or post-operative pain conditions. The HOMEWAVE(TM) system, which uses the same neuromodulation technology but employs non-invasive electrodes rather than the PEA, will be prescribed for home use by these physicians following 4 - 6 successful DEEPWAVE® treatments in the office, clinic or hospital. Biowave has completed multiple clinical studies, including blinded randomized controlled trials, which have shown that a single 20 - 30 minute treatment immediately provides patients with a 75% average reduction in pain and a significant increase in range of motion which lasts for up to 24 hours. Biowave products provide results similar to implantable neuromodulation devices without the risk and at a fraction of the cost. Biowave Corporation is a neuromodulation pain therapy company whose major goal is to help physicians and surgeons manage their patients' pain and reduce or eliminate the use of opiates, NSAIDs and their associated side effects. August 30th: Atrium Medical Corporation Receives FDA Approval for the iVENA(TM) Vascular Patch Atrium Medical Corporation announced today that it has received U.S. FDA 510K marketing clearance for a new vascular implant device called the iVENA(TM) Vascular Patch. Indicated for use in the surgical repair and closure of the vascular system, Atrium's latest implant technology is an extremely thin, reinforced biomaterial that suggests unsurpassed surgical installation convenience, reduced blood loss and handling efficiency. The iVENA(TM) Vascular Patch provides today's discriminating vascular surgeon with an easy-to-use alternative to conventional implantable vascular repair materials. This new product utilizes a proprietary composite film lamination process that is also used in Atrium's most advanced vascular graft products called FLIXENE(TM). The all new iVENA Vascular Patch offers physicians an extremely thin and flexible composite material that exhibits superior needle hole strength and anastomotic suture line integrity. It will be made in a wide variety of shapes and sizes to accommodate surgical interventions of the vascular system, and it is expected to become commercially available in the first quarter of 2007. Atrium's iVENA(TM) Vascular Patch technology is the latest advance in a series of unique biotechnology innovations, built upon 2 decades of excellence in Cardiovascular implant and biomaterial science. This late breaking med-tech product is also part of the company's evolving drug eluting and coating developments, currently in preclinical research. Atrium Medical Corporation of Hudson, New Hampshire, celebrating 25 years of US based healthcare innovation manufactures over two million sterile medical devices each year which are distributed worldwide. Atrium's vast expertise in developing medical device technologies for the treatment of cardiovascular disease has brought a number of breakthrough advances in several diversified healthcare markets including interventional cardiology, chest trauma care and thoracic drainage, vascular surgery, hernia and soft tissue repair. August 31st: World's Largest Drug-Eluting Stent Registry Reaches Halfway Point in Enrollment Boston Scientific Corporation announced today that enrollment has exceeded 13,000 patients in the TAXUS OLYMPIA registry, designed to evaluate the safety and performance of the Company's second-generation drug-eluting coronary stent (DES), TAXUS® Liberte(TM)(1), in a real-world setting. OLYMPIA is the world's largest DES registry and plans to enroll up to 27,000 patients treated for complex coronary lesions, at more than 500 centers worldwide. The multi-center, prospective, observational OLYMPIA registry will evaluate a variety of safety and performance measures, including the rate of repeat procedures (target lesion revascularization, or TLR), major adverse cardiac events such as heart attack (myocardial infarction) and death, and in-stent thrombosis. Additionally, sub-analyses on complex patient groups such as diabetics, patients with multi-vessel disease, in-stent re-blockages (restenosis) or a prior history of heart attack will be performed. The OLYMPIA registry is enrolling patients in multiple phases, corresponding to the commercial introduction of the TAXUS Liberte stent system in different regions of the world. The initial, transitional phase enrolled 529 patients from a limited number of international markets in which TAXUS Liberte is already commercially available. The six-month results from Phase I were presented at the SOLACI 2006 Congress in Porto Alegre , Brazil and showed a low overall TAXUS-related major cardiac event rate of 2.3 percent. Additional data will be presented at the European Society of Cardiology/World Congress of Cardiology 2006 in Barcelona, Spain. The TAXUS Liberte coronary stent system is the second generation to Boston Scientific's market-leading paclitaxel-eluting coronary stent system, TAXUS® Express2(TM). The Liberte stent features the Veriflex(TM) stent design, a highly flexible cell geometry with thin struts and uniform cell distribution. This new platform has been designed for uniform drug delivery and to offer improved deliverability and conformability in challenging anatomy. TAXUS Liberte is pending PMA approval and is not available for sale in the U.S. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.
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