Thursday, July 9, 2009

Smallest PFO Closure Device Gets EU OK

Filed under: Cardiac Surgery , Cardiology , Radiology

Coherex Medical out of Salt Lake City, Utah won the CE Mark to commercialize the firm's percutaneous endovascular FlatStent EF™ in the European market. The device is designed for closing the Patent Foramen Ovales (PFO).

About the device from Coherex:

The Coherex FlatStent EF device is similar in use and function to self-expanding vascular stents that are widely used around the world by interventional cardiologists. However, the patent-pending Coherex FlatStent EF device combines a planar Nitinol™ structure with a polyurethane substrate in a unique fusion of PFO closure mechanisms designed with the intent to naturally seal PFO tunnels.

According to Coherex President and CEO, Richard J. Linder, the Coherex FlatStent EF is the first device cleared for use to close a PFO from within the PFO tunnel.

“Although there are a handful of older, legacy devices cleared for closing PFOs, these devices are significantly larger than the Coherex FlatStent EF and they close PFOs by completely overlapping PFO openings on both sides of the septal wall,” Linder said. “Conversely, by its very design, the Coherex FlatStent EF represents the next generation approach to PFO closure. The Coherex FlatStent EF has dramatically less mass and less exposed surface area than other PFO closure systems and it is deployed almost entirely within the PFO tunnel (the only exception being two tiny anchors). As a result, the Coherex FlatStent EF uses a body’s natural defenses to enclose its polyurethane foam and Nitinol metal structure and thereby close the PFO opening from within the PFO tunnel. We believe this technology will be much safer for patients during the long term and reduce or eliminate safety concerns that are associated with older technologies."

EASE OF USE

Rapid-exchange functionality to simplify device delivery and maintain wire access throughout the procedure

Deployment similar to a self-expanding vascular stent

Single operator function

ONE DEVICE - THREE CLOSURE MECHANISMS

Lateral force to close tunnel from within

Foreign body response to stimulate endothelialization

Polymer substrate to promote cellular integration

PATIENT SAFETY

Low mass in left atrium to reduce risk of thromboembolism

Placement within tunnel to reduce risk of erosion

Device can be recovered and repositioned any time prior to detachment

Press release: Coherex Medical's Coherex FlatStent EF PFO Closure System Granted CE Mark Clearance for Closing PFOs...

Product page: COHEREX FlatStent EF™ PFO CLOSURE SYSTEM...

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