World’s Smallest Mechanical Heart Valve Wins FDA Approval

St. Jude Medical valve aids in treatment of birth defects

The FDA has approved the world’s smallest mechanical heart valve to aid in the treatment of congenital defects in newborns. The 15-mm valve size was added to the existing Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff (St. Jude Medical).

“While larger replacement heart valves have been approved for years, there is an unmet need in young pediatric patients, especially newborns and infants, with congenital valve defects who may be too small to use currently-marketed heart valves,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

Heart valve disease occurs if one or more of the four heart valves, which direct the flow of blood through the heart, fail to function properly. In pediatric patients, a malfunctioning heart valve is often the result of a congenital heart defect at birth. Each year, more than 35,000 babies in the U.S. are born with congenital heart defects, some of which will require heart valve surgery and, potentially, replacement heart valve surgery. However, prior to today’s approval, there have been limited replacement heart valve options available because of the patients’ small size. The Masters Series 15-mm valve represents an important treatment option for these patients.

The Master Series Mechanical Heart Valve is a rotatable, bileaflet (two-leaflet) valve designed for implantation in the aortic or mitral position. The bileaflet design consists of two semicircular discs that open and close in response to blood pressure changes during the heartbeat, similar to a patient’s own valve.

The Masters Series Mechanical Heart Valve was first approved in 1995 for patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. The device is also approved for use in replacing previously implanted aortic or mitral prosthetic heart valves. The new FDA approval expands the range of valve sizes available, providing smaller patients with another treatment option.

The FDA evaluated clinical data from a single-arm study of 20 pediatric patients with serious heart failure ranging in age from 1.5 weeks to 27 months at the time of mitral valve implant. The data showed that one year after the implant procedure, the probability of survival was 69.3% and the probability of not experiencing a valve-related adverse event was 66.8%. Serious valve-related adverse events observed during the study through one-year follow-up included blood clots in the device and bleeding in the brain. Anticoagulation (blood thinning) therapy may be necessary after the procedure, to prevent clotting on the device, which can increase the risk of bleeding.

The Master Series Mechanical Heart Valve should not be used by patients unable to tolerate anticoagulation therapy.

Source: FDA; March 6, 2018.