Blog Tag: Transcatheter Aortic Valve Replacement
Illinois-based Abbott Laboratories recently announced two transactions intended to increase Abbott’s presence in mitral valve replacement therapy and bolster its structural heart portfolio. First, Abbott will acquire Minnesota-based Tendyne Holdings, Inc. for $250 million. Second, Abbott provided capital and secured an option to purchase California-based Cephea Valve Technologies – financial terms were not disclosed.
According to its website, Tendyne is a private medical device company focused on minimally-invasive mitral valve replacement therapies and does not yet have a commercially available product. However, in April, the Minneapolis Heart Institute Foundation reported the first successful U.S. implant of a Tendyne heart valve. Tendyne’s Bioprosthetic Mitral Valve System has approval from the U.S. Food and Drug Administration for a feasibility clinical trial to provide data about the device’s safety and effectiveness. Enrollment in the trial has already begun. Tendyne also plans to begin a clinical trial in Europe to support a CE Mark.
Cephea Valve Technologies is a private company focused on developing a transcatheter mitral valve replacement therapy. Cephea’s valves are at an early stage of development and have not yet begun clinical trials.
Before Abbott announced these transactions, Abbott’s only structural heart product was MitraClip, an endovascularly-delivered device that has been used to treat more than 25,000 people. The Tendyne and Cephea valve technologies, like MitraClip, are designed to be implanted in a beating heart without the need for open heart surgery. John M. Capek, Ph.D., Executive Vice President of Ventures for Abbott stated:
The Tendyne acquisition and our agreement with Cephea broaden our foundation as one of the leaders in treatments for mitral valve disease, with the goal of bringing promising, less invasive valve treatment technologies to people who need them.
The mitral valve is positioned between the left upper and lower chambers in the heart. Some analysts believe that transcatheter mitral valves could address an even larger market than transcatheter aortic heart valves. There may be agreement among industry players: earlier this month, Edwards Lifesciences Corp., which has strong sales growth for its aortic valves, reached a $400 million deal to acquire CardiAQ Valve Technologies, another company focused on developing transcatheter mitral-valve replacement therapies.
FDA Approves Expanded Use of Medtronic’s CoreValve System; Also Receives Regulatory Approval in Japan
This week the U.S. Food and Drug Administration announced its approval of Medtronic’s CoreValve system for “valve-in-valve” (VIV) replacement. According to the FDA press release, this represents the first transcatheter aortic valve replacement device approved for use in replacing a previously implanted artificial valve. The press release explained the need for replacing artificial valves over time:
Some patients whose own aortic valve failed to work properly in the past undergo open-heart surgery to replace the faulty valve with an artificial heart valve. Over time, artificial valves that are made of animal tissue wear out—becoming narrowed, leaky or both—and may need to be replaced again.
The press release notes that prior to this approval, the only option for patients needing to replace an artificial aortic valve was open heart surgery; however, some such patients may not be qualified candidates for open heart surgery. The press release also stated that the CoreValve system can now provide a less invasive alternative for replacing artificial valves, thereby opening the option of subsequent valve replacements to a new category of patients. Medtronic provided data on the CoreValve Expanded Use Study Failed Bioprosthetic Surgical Valve on its website.
According to press releases, the CoreValve system also just received regulatory approval in Japan, in addition to previous regulatory approval in the U.S. and Europe.