Coherex Medical Inc. announced it has received CE Mark approval for its Coherex WaveCrest LAA Occlusion System.

Atrial fibrillation (AF) is the most common cardiac arrhythmia in today’s aging population, effecting nearly 6 million individuals in the US alone. AF causes the upper chambers of the heart to beat irregularly, slowing the flow of blood through these chambers and increasing the risk for stroke as this slower blood flow can cause clots to form.

Click here to see a video of the device.

The Left Atrial Appendage (LAA) is a pouch like cul-de-sac attached to the left atrium, which is recognized as the source of blood clots in approximately 90% of patients who have AF. Historically, patients who are at increased risk for stroke due to other medical conditions have had to take anticoagulants (blood thinners) to help prevent these clots from forming. These anticoagulant medications have many side effects, and in many patients may not be tolerated over the long term. The WaveCrest LAA Occluder is an implantable device that seals off the LAA opening so clots cannot escape into the blood stream and cause a stroke.

According to Coherex President and CEO Alex Martin, “The Coherex WaveCrest LAA Occluder provides substantial benefits for patients with AF who are at high risk for stroke. The WaveCrest is a one-time treatment option for patients who would otherwise be on a lifetime regimen of anticoagulation therapy or who are contraindicated to anticoagulants all together and would therefore, be unprotected from the risk of cardio embolism.”

Coherex recently presented results from the WAVECREST I clinical trial at the Paris Course on Revascularization (PCR). The company has been conducting a world-wide clinical trial to study the safety and efficacy of the WaveCrest LAA Occlusion System. Added Mr. Martin, “We are extremely proud of the clinical results to date and anticipate quick adoption of the device in the commercial setting.”