News | July 09, 2009

FlatStent EF PFO Closure System Gains CE Mark Clearance

July 9, 2009 – Coherex Medical Inc. today said its Coherex FlatStent EF PFO Closure System has been granted CE mark clearance for use in Europe and other countries to close patent foramen ovales (PFOs), a common heart defect found in approximately 20 percent of the worldwide population.

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, the company said.

The Coherex FlatStent EF is smaller than most PFO closure devices already on the market, and the current devices close PFOs by completely overlapping PFO openings on both sides of the septal wall. The company said its new device has dramatically less mass and less exposed surface area than other PFO closure systems, and it is deployed almost entirely within the PFO tunnel, except for two tiny anchors.

Coherex Medical was granted CE mark clearance for its Coherex FlatStent EF PFO Closure System following successful PFO closure procedures during its COHEREX-EU Study, a clinical trial conducted at sites in Germany, Switzerland, New Zealand and Australia.

A foramen ovale is a tunnel-like opening between the upper chambers of the heart that allows blood to bypass the lungs while a fetus is in the womb. Normally, the foramen ovale closes soon after an infant is born. However, sometimes this opening fails to close naturally after birth. Under certain conditions, a PFO may allow blood to bypass the lungs and shunt directly from the right side of the heart to the left. Since the lungs normally filter all blood flowing through the body, this shunt may allow unfiltered blood clots and other components to travel directly to the brain or other regions of the body.

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