Smallest available heart valve receives FDA approval

Kirk R. Kanter

The FDA announced the approval of a heart valve designed for pediatric patients has been expanded to include a size small enough to be used in newborn patients.

The approval of the valve (Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff, Abbott) now includes a 15-mm size, and that size of the device is now the smallest mechanical heart valve approved in the world, according to a press release from the agency.

The valve can be implanted in the aortic or mitral position.

“Valve problems in children are not uncommon. Our goal is to repair the valve and usually we're very successful, but on rare occasions, despite our efforts, we can't fix the valve and we have to replace it," Kirk R. Kanter, MD, professor of surgery, division of cardiothoracic surgery, department of surgery at Emory University School of Medicine, told Cardiology Today. "Most of the valves out there are made for adults because they have more valve problems than children, so this valve is very small. For the first time, there is a valve that we can put in a small child less than a year or even just a few months old, where in the past, we've struggled to find a valve that would fit.”

The valve first garnered FDA approval for use in patients with a diseased, damaged or malfunctioning aortic or mitral valve in 1995. The device is also approved as a replacement for previously implanted aortic or mitral prosthetic heart valves.

“I think it's important to recognize that every pediatric heart surgeon at all costs tries to avoid replacing a valve in young children and infants, but there is the occasional patient for whom this valve is the only FDA-approved solution, and therefore it's great to have it available," Kanter said in an interview. "Hopefully, I'll never have to use it again, but the reality is that I will and I'll be grateful to have it for that child."– by Dave Quaile

Disclosure: Kanter reports no relevant financial disclosures.