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Safe-Cross vessel wall detection technology approved in the US:

This article was originally published in Clinica

Executive Summary

Kensey Nash has received US FDA 510(k) clearance for its vessel wall detection technology. The Safe-Cross RF CTO system combines a guidance system and radiofrequency energy to safely cross and recanalise chronic total occlusions in the coronary and peripheral arteries. The clearance allows Kensey Nash, of Exton, Pennsylvania, to incorporate a new interferometer with greater dynamic range into the Safe-Cross console. This technology will allow the system to sense the vessel wall farther in advance, allowing the operator more time to adjust the direction of the wire. The updated console will undergo a period of user evaluations prior to broader market introduction. Kensey Nash expects to CE mark the new technology later this year.

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