WaveCrest Left Atrial Appendage (LAA) Occlusion System developed by Coherex Medical recently received CE Mark approval. Coherex Medical is a Salt Lake City, Utah company developing novel solutions for treatment of structural heart diseases.
In patients who have atrial fibrillation, slower blood flow through the atria can result in blood clots forming in the left atrial appendage in 10-20% of cases. LAA occlusion is a treatment strategy to prevent thrombosis in patients suffering from atrial fibrillation. LAA occlusion is used as an alternative for patients who cannot use oral anticoagulants such as warfarin. The Coherex WaveCrest Occluder is an implantable device that seals the LAA pouch so clots cannot escape into the blood stream and potentially cause a stroke.
The WaveCrest system stands out from other occluders by having a flexible design to accommodate a wide range of left atrial appendage anatomies. The implant is built from ePTFE (expanded polytetrafluoroethylene, aka Gore-Tex) that minimizes undesired thrombus formation on the outside of the occluder. The implant has independent anchors to stabilize the it after positioning, and it’s stated to have the most anchoring points of any available LAA occluder and a unique “Distal Injection Port” to assess device stability during the implant procedure.
Coherex President and CEO Alex Martin had the following to say, “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.”
Product page: Coherex WaveCrest…
CE Mark Approval: Coherex Medical announces CE mark for the WaveCrest LAA Occlusion System…