Coherex Medical, a developer of medical devices, has obtained CE Mark approval for its Coherex WaveCrest left atrial appendage (LAA) occlusion system.
WaveCrest LAA Occluder seals off the LAA opening so that blood clots cannot escape into the blood stream and cause a stroke.
Coherex president and CEO Alex Martin noted the CE-marked Coherex WaveCrest LAA occluder provides substantial benefits for patients with atrial fibrillation 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 added.
The company also entered into an exclusive distribution agreement for the implantable device with Biosense Webster.
As per the exclusive distribution agreement, Biosense Webster and its affiliated company Cordis will promote, train, sell and support the WaveCrest device globally, excluding the US.
Coherex WaveCrest device will be manufactured at Coherex Medical’s Salt Lake City facility.
Coherex is planning to carry out additional clinical trials that are designed to lead to final approval in the US and Japan, and anticipates to have a controlled product launch in Europe.