Healthcare Industry News: vascular closure
News Release - July 12, 2006
Kensey Nash Receives FDA 510(k) Clearance for TriActiv FX(R) Embolic Protection System
EXTON, Pa., July 12 (HSMN NewsFeed) -- Kensey Nash Corporation (Nasdaq: KNSY ) today announced that it has received 510(k) clearance for its next generation TriActiv FX® Embolic Protection System from the U.S. Food and Drug Administration (FDA). The product is expected to be launched shortly.The clearance was based on data collected from the ASPIRE (Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) Study which demonstrated that major adverse cardiac events (MACE) were reduced to 3.2% by using the TriActiv FX® System as an adjunct to stenting in treating saphenous vein grafts. Historically, MACE rates routinely were 15-20% in the same saphenous vein graft population without the use of embolic protection systems and approximately 5-10% in most previous studies using embolic protection systems. Reductions in MACE have been strongly correlated to improved mortality rates for the patient and new Practice Guidelines published by the American College of Cardiology in January 2006 now specifically recommend the use of distal embolic protection devices in patients undergoing treatment of saphenous vein grafts, when technically feasible.
"The ASPIRE Study demonstrated excellent results in three key areas: 30-day MACE (3.2%), in-hospital MACE (2.2%), and procedure time," commented Chris Metzger, MD, Co-Principal Investigator in the ASPIRE Study from Wellmont Holston Valley Hospital. "The compelling clinical results, coupled with the demonstrated ease-of-use of the TriActiv FX® System, should help advance the standard of care for SVG interventions," he said.
"We are confident that our TriActiv FX® System will be viewed as state-of-the-art in the embolic protection market," stated Joseph W. Kaufmann, President and CEO of Kensey Nash Corporation. "This device incorporates many new features that have improved ease-of-use and more importantly, clinical outcomes. Our new rapid exchange system and unique inflation device, combined with the truly compelling data from the ASPIRE Study, will set new standards in embolic protection. We firmly believe our comprehensive approach, which combines flushing and automated extraction with balloon protection, is of paramount importance to achieve the best clinical results. We are looking forward to launching this product as soon as possible," he concluded. The TriActiv FX® Embolic Protection System will be sold through Kensey Nash's direct U.S. endovascular sales force, along with its recently cleared QuickCat(TM), Extraction Catheter and ThromCat(TM) Thrombectomy Catheter System.
The TriActiv FX® System is a protection system designed to prevent material or debris, dislodged during stent procedures, from embolizing downstream and causing adverse coronary events such as a heart attack. This is accomplished with three integrated system features: an embolic protection balloon, and a combined active flush and extraction system to remove the problematic debris from the target vessel. The TriActiv® System is the only distal embolic protection system that actively removes the debris from the vessel by gently flushing the treatment area within the vessel. The TriActiv® ProGuard(TM) System is another version of the System that is currently in clinical studies to evaluate its performance in preventing strokes and other adverse events during carotid stenting procedures. The TriActiv ProGuard device is being commercialized in the European Union for treatment of SVG patients.
The TriActiv FX® System incorporates several important ease-of-use design enhancements to the TriActiv® System platform. These include a new balloon inflator that simplifies catheter exchanges during the procedure, and a new flush catheter design to enhance device usage and reduce procedure time.
About Kensey Nash Corporation. Kensey Nash Corporation is a leading medical technology company providing innovative solutions and technologies for a wide range of medical procedures. The Company provides an extensive range of products into multiple medical markets, primarily in the endovascular, sports medicine and spine markets. Many of the products are based on the Company's significant expertise in the design, development, manufacturing and processing of absorbable biomaterials, which has led to partnerships to commercialize technologies. Kensey Nash has also commercialized a series of innovative embolic protection and thrombectomy products through its own direct endovascular sales force. The Company is known as a pioneer in the field of arterial puncture closure, as the inventor and developer of the Angio-Seal(TM) vascular closure Device, which is licensed to St. Jude Medical, Inc.
Cautionary Note Regarding Forward-Looking Statements. This press release contains forward-looking statements that reflect Kensey Nash's current expectations about its prospects and opportunities, including, without limitation, expectations regarding Kensey Nash's TriActiv® System and its other endovascular products. Kensey Nash has tried to identify these forward-looking statements by using words such as "plans," "believes," "expects," "anticipates," "will," "should" or similar expressions, but these words are not the exclusive means for identifying such statements. Kensey Nash cautions that a number of risks, uncertainties, and other important factors could cause Kensey Nash's actual results, performance or achievements to differ materially from those expressed in, or implied by, these forward-looking statements, including, without limitation, the ability of Kensey Nash to obtain necessary regulatory approvals for other versions of the TriActiv® System and other new endovascular products, the ability of Kensey Nash to successfully market the TriActiv® System and other endovascular products, and competition from other technologies in the embolic protection market. For a more detailed discussion of these and other factors, please see Kensey Nash's filings with the Securities and Exchange Commission. Except as expressly required by the federal securities laws, Kensey Nash undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.
Source: Kensey Nash
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