Healthcare Industry News: vascular closure
News Release - February 15, 2006
Kensey Nash Receives CE Mark Approval for New TriActiv(R) ProGuard(TM) Embolic Protection SystemEXTON, Pa., Feb. 15 (HSMN NewsFeed) -- Kensey Nash Corporation (Nasdaq: KNSY ) today announced it has received CE Mark approval for the third generation of its embolic protection technology known as the TriActiv® ProGuard(TM) System. The Company plans to launch the TriActiv® ProGuard(TM) System in Europe for use in saphenous vein graft procedures by the end of the quarter.
The TriActiv® ProGuard(TM) System incorporates several important design enhancements to the TriActiv® System platform. These include Local Flush and eXtraction (LFX(TM)) technology that allows the system to better address branched anatomy and a new, smaller 6F compatible size, which is generally preferred by physicians, particularly in Europe.
"This is a very important product introduction for the European market," commented Joe Kaufmann, President and CEO of Kensey Nash Corporation. "The ProGuard(TM) design allows for greater utility of the system through its ability to be used in branched vessel situations and its highly desirable 6F compatibility. The flexibility of this product to be used in branched anatomy is a fundamental enhancement to the TriActiv® System product line. Kensey Nash will now actively pursue study of the platform's utility in the native coronary and leg and renal peripheral anatomies, as a complement to our ongoing study of the TriActiv® ProGuard(TM) System in the carotid anatomy. We are now significantly closer to our objective of offering our physician customers in Europe a complete line of first class embolic protection products," he concluded.
The TriActiv® ProGuard(TM) 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. In addition to being approved for sale in Europe for a saphenous vein graft indication, the TriActiv® ProGuard(TM) System is also in clinical studies to evaluate its performance in preventing strokes and other adverse events during carotid stenting procedures.
About Kensey Nash Corporation. Kensey Nash Corporation is a leading developer and manufacturer of absorbable biomaterials-based products with applications in the cardiology, orthopaedics, spine, drug and biologics delivery, periodontal/dental, surgical and wound care markets. The Company was 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. The TriActiv® System, a novel embolic protection system, is cleared for sale in the U.S. The TriActiv FX® System, the second generation of the TriActiv® System, is approved for sale in the European Union. Regulatory clearance for the TriActiv FX® is pending in the U.S.
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. Kensey Nash has tried to identify these forward-looking statements by using words such as "believe," "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 successfully market the TriActiv® System 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
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.