Healthcare Industry News: ASPIRE study
News Release - November 14, 2006
Kensey Nash Announces Commencement of Carotid Pivotal Trial for TriActiv ProGuard SystemEXTON, Pa., Nov. 14 (HSMN NewsFeed) -- Kensey Nash Corporation (Nasdaq: KNSY ) today announced that it has commenced enrollment of a 300 to 400 patient pivotal study for its TriActiv ProGuard Embolic Protection System in carotid stenting procedures. If successful, the PROGUARD trial will support a 510(k) submission, currently anticipated in early 2008 following the expected completion of enrollment.
Gary S. Roubin, M.D., Ph.D., Chairman, Department of Interventional Cardiology,Lenox Hill Hospital, New York, NY and Rajesh Dave, M.D., Chairman, Endovascular Medicine, PinnacleHealth Heart and Vascular Institute, Harrisburg, PA will serve as co-principal investigators for the study, which will take place at up to 35 U.S. sites and 5 European sites.
"Practitioners continue to need better solutions to prevent debris from reaching the brain during carotid stenting," commented Dr. Roubin. "We believe that the TriActiv ProGuard(TM) System offers some significant benefits, and so we are looking forward to studying this device in a large comprehensive study. I have been impressed with the ease of use and short occlusion times of Kensey Nash's balloon protection system. These attributes of the device are compelling," he added.
Earlier this year, Kensey Nash completed a pilot trial to study the safety of the TriActiv® ProGuard(TM) device in carotid patients at 5 sites in the U.S. and Europe. The data showed no incidence of major strokes or death in the 50 patient study. That data is supporting a CE Mark application, currently pending, which would allow use of the device during carotid stenting procedures in Europe.
Dr. Dave, who performed the first U.S. cases of the PROGUARD trial, added his comments. "As carotid stenting continues to be adopted, the effectiveness of embolic protection systems to prevent major adverse events (MAE) is paramount. The data from the TriActiv ProGuard(TM) pilot trial suggests that balloon protection in combination with the gentle flushing and automated extraction is a promising solution," he concluded.
The TriActiv ProGuard System is the Company's newest version of the TriActiv System product line, which incorporates Local Flush and eXtraction (LFX) technology designed for use in branched arteries, such as those of the carotid blood vessels. The TriActiv ProGuard System incorporates three features designed to reduce the incidence of embolic stroke during carotid stenting procedures - a balloon protection guidewire, a flush catheter, and an automated extraction system to remove debris. The system has been studied and can be used in combination with any approved stent in the marketplace.
Carotid artery disease is an additional target indication for the TriActiv product offering that includes TriActiv FX and the new investigational TriActiv ProGuard Systems. Each year, there are over 200,000 surgical endarterectomies performed worldwide to treat carotid artery disease. It is also known that a significantly larger number of patients are affected by the disease, with many going untreated due to the invasiveness of a surgical procedure. With the advent of carotid stenting in combination with embolic protection devices continuing to show promising results, the Company believes that carotid stenting will become the standard of care for the treatment of carotid artery disease.
The TriActiv FX System is currently indicated to prevent heart attacks during the treatment of saphenous vein grafts (SVGs) in patients who previously received coronary bypass surgery, but now have blockages in the grafts. The Company recently released data from the ASPIRE study registry which showed a low 3.2% major adverse cardiac event (MACE) rate in SVG patients, the lowest MACE rate among all multi-center studies of embolic protection in this patient subset. The TriActiv ProGuard has CE Mark and is being sold in Europe for a saphenous vein graft indication.
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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