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Structural Heart


After receiving reports regarding reduced leaflet motion in some bioprosthetic aortic valves, the FDA announced on Oct. 5 that the agency is working with the American College of Cardiology, the Society of Thoracic Surgeons and device manufacturers to design clinical studies to evaluate the situation.


Recent Headlines

Medtronic agrees to acquire privately-held TMVR device manufacturer

Medtronic agreed to acquire Twelve, a private medical device company that is developing a transcatheter mitral valve replacement (TMVR) device. The $458 million transaction is expected to close in October, according to a Medtronic news release.

Medtronic recalls EnVeo R loading systems

Medtronic recalled 6,912 units of the EnVeo R loading systems after receiving two reports of particulates in packaged kits and six reports of particulates in the loading bath during valve loading as of July 6.

Abbott commits to mitral valve disease treatments with two transactions

With two transactions on July 30, Abbott strengthened its structural heart business and emphasized its focus on treatments for mitral valve disease.

After 2 years, low stroke rates in TAVR patients

Fewer than six percent of patients who underwent transcatheter aortic valve replacement (TAVR) with the CoreValve device had strokes within two years of the procedure, according to a recent study. Researchers mentioned the 5.6 percent overall stroke rate was relatively low considering all patients were high-risk and had symptomatic aortic stenosis.

Moving TAVR forward

We expect the Supreme Court to act, at least once it commits to a case. The FDA, that’s another thing. But the FDA has been on a relative tear this month with nearly back-to-back approvals of two different transcatheter aortic valve replacement (TAVR) systems.

FDA waves in first retrievable, repositionable TAVR device

The FDA approved Medtronic’s CoreValve Evolut R device on June 23, giving physicians in the U.S. who perform transcatheter aortic valve replacement (TAVR) procedures the ability to recapture and reposition a valve during implantation.

FDA clears Sapien 3 for high-risk TAVR patients

The FDA approved the third-generation transcatheter aortic valve replacement (TAVR) device by Edwards Lifesciences, giving the company permission to market the Sapien 3 system as a treatment for high-risk patients with severe aortic stenosis.

TAVR in lower-risk patients looks likely but questions linger

CHICAGO—Transcatheter aortic valve replacement (TAVR) is poised to move in a new direction—down, according to presenters at the Transcatheter Valve Therapies conference in Chicago.

Surgery for degenerative mitral valve disease becoming more safe, effective

An analysis of more than 25 years of data at the Cleveland Clinic found that surgical procedures were more successful than “watchful waiting” for patients with severe degenerative mitral regurgitation.

TAVR’s chance to improve safety

Proponents of transcatheter aortic valve replacement (TAVR) have taken lessons from of others to orchestrate careful rollouts in Europe and the U.S. That cautious attitude could extend to other aspects of TAVR as well.