Coherex Medical, a US-based medical device maker, has received CE Mark approval for its WaveCrest left atrial appendage (LAA) occlusion system.
The Coherex WaveCrest is the company's latest innovation in left atrial appendage occlusion.
LAA occlusion is a treatment strategy to prevent blood clot formation in patients suffering from atrial fibrillation (AF), the most common cardiac arrhythmia in today's ageing population, affecting nearly six million people in the US alone.
The WaveCrest system is attached to the left atrium, which is recognised as the source of blood clots in approximately 90% of patients who have AF.
The implantable device seals off the LAA opening, preventing the clots from escaping into the blood stream and causing a stroke.
Coherex president and CEO Alex Martin said 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 altogether and would therefore be unprotected from the risk of cardio embolism," Martin said.
"We are extremely proud of the clinical results to date and anticipate quick adoption of the device in the commercial setting."
Coherex recently unveiled the results from the WAVECREST I clinical trial at the Paris Course on Revascularization (PCR).
The company is currently conducting a worldwide clinical trial to study the safety and efficacy of the WaveCrest system.
Coherex expects to have a controlled product launch in Europe and is also planning to conduct additional clinical trials for regulatory approval in the US and Japan.
The company also entered into an exclusive distribution agreement with Biosense Webster for the Coherex WaveCrest system.
Under the terms of the agreement, Biosense Webster will have exclusive worldwide distribution rights, excluding the US, for the CE-marked Coherex WaveCrest device.
Manufactured at Coherex's facility in Salt Lake City, the Coherex WaveCrest device will be promoted and sold by Biosense Webster, along with its affiliated company, Cordis Corporation.
According to GlobalData estimates, the interventional cardiology market, which was valued at $2.54bn in 2012, is expected to grow at a CAGR of2.3% to reach $2.99bn by 2019.