OCTOBER 15, 2008 -- Kensey Nash Corp. (Exton, PA) says it has completed development on a next generation version of the Safe-Cross RF CTO System, designed to safely cross and recanalize chronic total occlusions (CTOs) in the coronary and peripheral arteries. An enhanced user interface, combined with the improved optical system that received 510(k) clearance in February, promises physicians a superior visual display of the data transmitted from the Safe-Cross guidewire in the vessel during treatment of artery occlusions. Completion of the development meets the criteria established for the first milestone payment to Kensey Nash of $1 million under the company's R&D agreement with Spectranetics Corp., which recently purchased rights to the product from Kensey Nash.
Safe-Cross 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. It is reportedly the only commercial product that combines forward guidance with a crossing mechanism in a familiar guidewire configuration. It promises 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.
With this OCR-based guidance technology, near infrared light is transmitted and received through a small optical fiber incorporated into the guidewire. The 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 allows RF energy to be released only when the guidewire is directed safely within the lumen of the vessel.
The Safe-Cross RF CTO System