Kensey Nash Receives FDA 510(k) Clearance for New Safe-Cross(R) Vessel Wall Detection ...( EXTON Pa. Feb. 20 /- Kensey Nash ...)

EXTON, Pa., Feb. 20 /PRNewswire-FirstCall/ -- Kensey Nash Corporation (Nasdaq: KNSY) today announced that it has received 510(k) clearance for an important vessel wall detection technology from the U.S. Food and Drug Administration, designed to enhance the guidance provided by 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.

The clearance allows Kensey Nash to incorporate a new interferometer with greater dynamic range into the Safe-Cross console, an important element of the System involved in vessel wall detection. The advanced technology will allow the System to sense the vessel wall farther in advance. Earlier vessel wall detection should provide the physician operator with more options to redirect the wire while crossing a chronic total occlusion.

"We believe this will be a very significant advancement for our Safe-Cross technology," commented Douglas G. Evans, Chief Operating Officer of Kensey Nash Corporation. "While the mechanism of detection is identical to our current Safe-Cross System, the new high dynamic range interferometer should allow a physician to detect the vessel wall sooner, and to have more flexibility to make appropriate adjustments with the direction of the wire. We believe this will be a welcome advancement in the treatment of challenging CTO lesions," he concluded.

Safe-Cross consoles incorporating the new technology will undergo a period of user evaluations prior to broader market introduction. This new technology has also been submitted in a design dossier for CE Mark approval, expected later this year. Separately, K
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