FDA Approves World's Smallest Heart Valve
Orange County, CA - March 7th, 2018 -
Although adult sized heart valves have been FDA approved since 1995, small heart valves were only recently approved by the Food and Drug Administration. The Masters HP 15mm rotatable mechanical heart valve can be used to replace either mitral or aortic valves that are not good candidates for repair procedures. The valve, now also in sizes ranging from 15mm to 27mm, features two pyrolytic carbon leaflets, an 85-degree opening angle that promotes blood flow while reducing turbulence, and a way to rotate the device during implantation to achieve ideal results.
Measuring no larger than a dime, this life-saving device provides a new treatment option to address a growing need. Nearly 1 in 4 children with critical heart defects may require surgery or other life-saving procedures in their first year. The Masters HP 15mm heart valve was created by Illinois based Abbott Laboratories which also sells research-based drugs, medical devices, diagnostics, and nutritional products.
“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 also enrolled the most patients for the clinical trial that led to the 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.”
When the tissues of a heart valve have significant deformities or are too damaged and cannot be repaired to restore proper function, it is sometimes necessary to replace the valve with a mechanical valve. A mechanical heart valve mimics the valve of a healthy heart, opening and closing with each heartbeat, permitting proper blood flow through the heart.
“There’s an urgent need for the smallest babies and children who need a suitable replacement valve in order to survive,” said Michael Dale, vice president of Abbott’s structural heart business. “Abbott’s new mechanical pediatric heart valve is a life-changing technology for the smallest pediatric patients, giving them a better chance at a long, healthy life with a fully functioning heart.”
Abbott’s new Masters HP15mm rotatable mechanical heart valve was primarily approved by the FDA based on the results of a clinical trial which enrolled pediatric patients five years of age or younger who had a diseased, damaged or malfunctioning heart valve. Sadie Rutenberg was the first infant to undergo the treatment in the clinical trial and she is now a healthy 3-year-old. Sadie’s successful surgery and post-op life paved the way for the eventual FDA approval of this life-saving heart valve.
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Ampronix is a renowned authorized master distributor of the medical industry's top brands as well as a world-class manufacturer of innovative technology. Since 1982, Ampronix has been dedicated to meeting the growing needs of the medical community with its extensive product knowledge, outstanding service, and state-of-the-art repair facility. Ampronix prides itself on its ability to offer tailored, one-stop solutions at a faster and more cost-effective rate than other manufacturers. Ampronix is an ISO & ANSI/ESD certified facility. To learn more go here.
FDA Approves World’s Smallest Heart Valve Orange County, CA – March 7th, 2018 – Although adult sized heart valves have been FDA approved since 1995, small heart valves were only recently approved by the Food and Drug Administration. The Masters HP 15mm rotatable mechanical heart valve can be used to replace either mitral or aortic valves that are […]