Based in Irvine of California, CardiAQ is a privately held firm that developed transcatheter mitral valve replacement system.
Edwards Lifesciences chairman and CEO Michael Mussallem said: "We believe the acquisition and integration of CardiAQ will advance our development of a transformational therapy for patients with mitral valve disease who aren’t well-served today."
CardiAQ’s proprietary transcatheter mitral valve (TMV) implant is said to be delivered through multiple delivery systems.
The product features unique anchoring mechanism that engages and utilizes the patient’s native mitral valve anatomy, allowing to fix a new mitral valve within a beating heart without circulatory support and prevents open-heart surgery.
CardiAQ obtained investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for the product to initiate an early feasibility study of up to 20 patients and also intends to conduct a CE mark study in Europe.
Recently, Edwards completed its review and has reached agreement on protocol revisions to re-start enrollment in the Fortis program.
The CardiAQ and Fortis valve systems have not yet received approval for sale in any country.
Image: Edwards Lifesciences to acquire transcatheter mitral valve replacement system developer CardiAQ. Photo: courtesy of PinkBlue/ FreeDigitalPhotos.net.
