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FDA Expands Approval of Replacement Heart Valve

Masters HP™ 15mm rotatable mechanical heart valve
Masters HP™ 15mm rotatable mechanical heart valve (Source: Abbott)

Smallest mechanical valve size approved in the world

Silver Spring, Maryland—(ENEWSPF)—March 8, 2018

By: Rosemary Piser

The Food and Drug Administration (FDA) announced that is has expanded the approval of a heart valve about the size of a dime that can be used to treat heart defects in newborn pediatric patients defects. The Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff will include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.

Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health said, “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.”

“In my practice, I want to be able to provide a treatment option that works for a critically ill child when a larger-sized valve may not be suitable,” said Kirk R. Kanter, M.D., professor of surgery and director of the Heart Transplant Program at Children’s Healthcare in Atlanta at Emory University School of Medicine, which was the top enrolling site for the trial that led to approval of this new treatment option. “The approval of this smaller pediatric mechanical heart valve provides surgeons with a much-needed option for treating these vulnerable, high-risk children.”

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. Previously there have been limited replacement heart valve options available because of the patients’ small size. The Masters Series 15-mm HP valve represents an important treatment option for these patients.

Sadie Rutenberg, now a 3-year-old, was only a few months old when her parents noticed she was breathing fast, stopped gaining weight and was not eating well due to a congenital heart problem.

“When we were told that Sadie would need surgery right away, and was a candidate for a new clinical trial of a heart valve sized for her small body, we were willing to try it to hopefully save her life,” said Lee’or Rutenberg, Sadie’s father. “When the doctor came out of surgery and told us the surgery was a success – as a parent, it’s a moment I’ll never forget. The valve saved Sadie’s life.”

Watch Sadie’s story here:

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 FDA granted approval of the Master Series Heart Valve to St. Jude Medical.

Sources: www.fda.gov and www.abbott.com

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