Healthcare Industry News: ASPIRE study
News Release - March 7, 2006
Kensey Nash Announces Low 3.2% MACE Rate Achieved Using New TriActiv FX(R) Embolic Protection SystemMajor Adverse Cardiac Events, Heart Attacks, and Procedure Times Substantially Reduced with New System
EXTON, Pa., March 7 (HSMN NewsFeed) -- Kensey Nash Corporation (Nasdaq: KNSY ) today announced that a low major adverse cardiac event (MACE) rate of 3.2% was achieved in its recent ASPIRE study, which studied the effectiveness of the new TriActiv FX® Embolic Protection System to reduce MACE during the treatment of diseased saphenous vein grafts (SVG). Prior to the advent of embolic protection systems, MACE rates in the SVG patient population were routinely 15-20%. The use of embolic protection systems has helped reduce MACE rates to the 7-10% range in most previous studies. Kensey Nash believes that the 3.2% rate is the lowest recorded to date from a sizable multi-center study of the SVG population, and is less than half of the next best data set widely quoted by the cardiology community.
The rate of heart attacks in the ASPIRE study, included as part of the MACE rate, was also a low 2.2%, which is a 67% reduction in the rate seen in the next best embolic protection device's data set. Kensey Nash also noted that procedure times were on average 15 minutes below the control cohort of the other embolic protection systems, suggesting advancements in ease of use with the new device.
ASPIRE (Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) was a multi-center, prospective registry which enrolled over 100 patients, and was designed to support regulatory clearance of the TriActiv FX® System in the U.S. for a saphenous vein graft (SVG) indication. The Company submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the new TriActiv FX® System in January 2006. The complete data set from the ASPIRE study will be highlighted during the upcoming American College of Cardiology (ACC) conference in March 2006 in Atlanta, Georgia.
"Kensey Nash has done a phenomenal job of achieving what very few thought was possible," commented Dr. Chris Metzger, co-Principal Investigator of the ASPIRE study, about the TriActiv FX® System. "To date, virtually all major data sets, generated using the best technologies available, have been in the 7-10% MACE range. With procedure times being substantially reduced due to the product's ease of use, and these extremely compelling results, the TriActiv FX® System offers the physician community an important advancement in embolic protection technology. We are very happy to see this new standard set for the benefit of our patients," he said.
"This is landmark data in the field of embolic protection," stated Joseph W. Kaufmann, President and CEO of Kensey Nash Corporation. "This data has set a new standard supporting our belief that balloon protection provides the most effective means of preventing debris from migrating distally to the microvasculature, thus improving patient outcomes. We are very excited about the promise that the ASPIRE study holds for the future of embolic protection," he concluded.
The Co-Principal Investigators of the ASPIRE study were Drs. Christopher Metzger, Wellmont Holston Valley Medical Center, Kingsport, TN and Joseph Carrozza, Beth Israel Deaconess Medical Center, Boston, MA. Twenty centers participated in the study. The lead enrollers in the Study were Michael Haude, Universitatsklinikum, Essen, Germany; Hubertus Heuer, St. Johannes Hospital, Dortmund, Germany; Nicholaos Xenopoulos, Jewish Hospital, Louisville, KY; Michael Mumma, Sarasota Memorial Hospital, Sarasota, FL; Gary Roubin, Lenox Hill Hospital, New York, NY; and Chris Metzger, Wellmont Holston Valley Medical Center.
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 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. Recently, the Company has created an endovascular division to launch its novel TriActiv® Embolic Protection System, a device designed to prevent debris from traveling downstream from the treatment site during stenting procedures. Kensey Nash is commercializing several versions of the device including TriActiv FX® and TriActiv® ProGuard(TM) Systems and is also planning to launch the ThromCat(TM) Thrombectomy System and QuickCat(TM) Extraction Catheter as new endovascular products. Kensey Nash is also 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 the TriActiv FX®, 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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