Latest Edwards Lifesciences Purchase Boosts TMVI Portfolio

Edwards Lifesciences has bolstered its transcatheter therapy portfolio by acquiring CardiAQ Valve Technologies for $400 million. Edwards will pay $350 million in cash upon closing of the deal, and another $50 million upon completion of a European regulatory milestone. CardiAQ, which has developed an early-stage transcatheter mitral valve implantation (TMVI) system, is considered a solid complement to Edwards’ own TMVI device, Fortis.

“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,” said Michael A. Mussallem, Edwards’ chairman and CEO. “While still early in the development of this therapy, the progress of the team of employees and clinicians working on our Fortis mitral replacement system has reinforced our confidence in a catheter-based approach. We believe the experiences and technologies of Fortis and CardiAQ are complementary and that this combination will enable important advancements for patients.”

Both the Fortis and CardiAQ are catheter-based implants that are less invasive than conventional open-heart surgery for patients suffering from mitral regurgitation (MR). The Fortis device uses a transapical approach, while the CardiAQ can be implanted using either a transapical or transfemoral approach. The CardiAQ device is a self-conforming, self-anchoring technology for nonsurgical, transfemoral-transseptal, percutaneous TMVI.

CardiAQ has received a U.S. Food and Drug Administration investigational device exemption approval to conduct an early feasibility study of up to 20 patients, and also plans to initiate a CE mark study in Europe, according to the statement.

“CardiAQ currently offers the only transvessel implantation approach to treating MR. While several organizations have focused on a transapical approach to replace the mitral valve, we are the only company to have realized transfemoral-transseptal human implants,” Rob Michiels, CEO of CardiAQ Valve Technologies, said in a previous news release.

Last year, Irvine, Calif,-based Edwards successfully implanted Fortis transcatheter mitral valve devices in the first three human subjects. In May, however, it voluntarily halted the study after blood clots were observed to have developed in some of the 20 patients who received the device so far. The company said in its recent statement that it is working closely with global clinical investigators in revising some study protocols to be able to re-start enrollment.

Given the uncertainty with Fortis, Edwards likely will make “the CardiAQ platform to be the primary TMVI platform moving forward,” Northland Capital Markets’ Suraj Kalia told Barron’s. Acquiring CardiAQ’s TMVI technology also is a good addition to Edwards’ transcatheter aortic valve replacement business—which is anchored by its Sapien valves—helping to cement the company’s status as a pioneer and a leader in heart valve replacement technologies.