Kensey Nash Receives FDA 510(k) Clearance for New Safe-Cross(R) Vessel Wall Detection ...(ensey Nash has additionalimprovements un...)

Date:2/20/2008

ensey Nash has additional improvements underway for the Safe-Cross product line, which will require separate regulatory clearances. Kensey Nash is now finalizing a completely new user interface, designed to simplify the presentation of information important to the physician user. The new user interface, as well as other minor software enhancements, are planned to be introduced in Kensey Nash's fiscal 2009 year.

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 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.

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