Edwards Lifesciences announced on July 10 that it had agreed to acquire CardiAQ Valve Technologies, the developer of an investigational transcatheter mitral valve replacement system. The purchase price is up to $400 million, including $350 million in cash at closing, according to the announcement.
In a news release, Edwards CEO Michael A. Mussallem said the system is complementary with its Fortis mitral transcatheter heart valve, which is also not FDA-approved. The FDA granted CardiAQ an investigational device exemption to conduct an early feasibility study of up to 20 patients.
In May, Edwards voluntarily paused enrollment in a Fortis clinical trial program after noticing evidence of valve thrombosis. More than 20 patients with symptomatic mitral regurgitation have been treated with the Fortis valve, according to Edwards.
Edwards said that it had worked closely with investigators from the Fortis trial program, recently completed its review and "has reached agreement on protocol revisions to re-start enrollment" in the program.
“While it is still very early in the program, and we anticipated that optimizing this therapy would be challenging, we are continuing to learn which patients may benefit,” Edwards said in a news release on May 19. “We remain committed to and are encouraged by the early experience in transcatheter mitral valve replacement therapy.”