Vessel Wall Detection System Approved
The Food and Drug Administration has approved the Safe-Cross System, designed by Kensey Nash Corporation. The system is designed to support vessel wall detection during interventional procedures. The system is indicated for use in treating occlusions in peripheral and coronary arteries. The system has also been submitted to obtain the CE Mark, as described in the press release from the company.
The new system is used in cooperation with the company’s Safe-Cross RF CTO System. The new technology employs radio frequency energy and a forward-looking guidance system to allow safe crossing and recanalization of chronic total occlusions. The company suggests that this new product may modify the standard approach to treat these sorts of occlusions.
With this approval from the FDA, Kensey Nash also introduced a new interferometer that provides a greater dynamic range into the Safe-Cross Console system. That is a key component of the detection of vessel walls. The newly approved technology supports earlier detection of vessel walls, which provides physicians guiding the system with more options for wire redirection during cross of a total occlusion. Before the system is marketed on a broad basis, the company will complete user evaluations.
The new system is virtually identical to that already used with the Safe-Cross System. The difference is that this newly approved system incorporates the high dynamic range interferometer. This provides clinicians with adequate time to adjust the direction of the wire.
At the same time, the company is planning additional improvements to the Safe-Cross product line. Those will require additional approvals from the FDA. One component being developed is a newly designed user interfacer, along with enhancements to the program software.
February 27, 2008 Related topics: Product Approval & Certification, New Technology & Innovation, Surgery, Cardiology, Materials Management