EXTON, Pa., Oct. 14 /PRNewswire-FirstCall/ -- Kensey Nash Corporation today announced that it has completed development on a next generation version of the Safe-Cross(R) RF CTO System. The Safe-Cross System combines a forward-looking guidance system and radio frequency (RF) energy to safely cross and recanalize chronic total occlusions in the coronary and peripheral arteries. This next generation device features an enhanced user-friendly interface, providing the physician with a new visual display of the data transmitted from the Safe-Cross guidewire in the vessel. This enhancement, combined with the improved optical system that had received 510(k) clearance in February 2008, will provide physicians with a superior product when navigating the Safe-Cross guidewire during the treatment of chronic occlusions of the arteries. Completion of the development process meets the criteria established for the first milestone payment to Kensey Nash of $1 million under the Company's research and development agreement with The Spectranetics Corporation .
"We are pleased to announce the achievement of the first milestone and to provide Spectranetics with this next generation device," commented Joseph W. Kaufmann, Chief Executive Officer of Kensey Nash Corporation. "The improved optics and user friendly enhancements of the new Safe-Cross System should help physicians to more effectively treat patients with chronic total occlusions."
The Safe-Cross(R) RF CTO System
The Safe-Cross System is designed to safely cross CTOs using Optical Coherence Reflectometry (OCR) technology as guidance and Radio Frequency (RF) as an energy source to penetrate the difficult lesions. The Safe-Cross(R) System is the only commercialized product that combines forward guidance with a crossing mechanism in a familiar guidewire configuration. The Safe-Cross System is designed to give the interventionalist real-time feedback as to the proximity of the crossing wire to the arterial wall plus the capability to use RF power on the tip of the wire to assist in penetrating hardened material within the artery, thus facilitating safe and successful passage and placement of therapeutic devices for recanalization in native coronary and peripheral arteries.
This guidance technology is based on optical coherence reflectometry, with near infrared light being transmitted and received through a small optical fiber incorporated into the guidewire. This near infrared signal is analyzed through an interferometer to resolve the reflections by distance, a process analogous to that of ultrasound, but with light rather than acoustic waves. If the vessel wall is detected, RF energy cannot be released and the operator is visually warned of the guidewire's proximity to the wall. The operator can then redirect the guidewire to remain in the lumen and continue its progress through the occlusion. The Safe-Cross System only allows RF energy to be released when the guidewire is directed safely within the lumen of the vessel.
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 orthopaedic fields of sports medicine, spine, and extremities, as well as the cardiovascular fields of vascular closure, thrombus (blood clots) removal, and the treatment of chronic total vascular occlusions. 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 developed and commercialized a series of innovative endovascular products and recently completed the sale of this product line to The Spectranetics Corporation. In conjunction with the sale transaction, the Company will continue to manufacture and develop these products for Spectranetics for a period of time. 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 for Forward-Looking Statements
This press release contains forward-looking statements that reflect the Company's current expectations about its prospects and opportunities. The Company has tried to identify these forward looking statements by using words such as "expect," "anticipate," "estimate," "plan," "will," "forecast," "believe," or similar expressions, but these words are not the exclusive means for identifying such statements. The Company cautions that a number of risks, uncertainties, and other important factors could cause the Company's actual results to differ materially from those in the forward-looking statements including, without limitation, the Company's success in launching its endovascular products into the marketplace, the Company's dependence on major customers and partners (St. Jude Medical, Arthrex, Orthovita and Spectranetics) and their success in selling Kensey Nash related products in the marketplace, the impact of product recalls and other manufacturing issues, and competition from other technologies, among other important risks. For a more detailed discussion of these and other factors, please see the Company's SEC filings, including the disclosure under "Risk Factors" in those filings. Except as expressly required by the federal securities laws, the Company 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.
