Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.
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. Today’s approval expands the range of valve sizes available, providing smaller patients 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 percent and the probability of not experiencing a valve-related adverse event was 66.8 percent. 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 FDA granted approval of the Master Series Heart Valve to St. Jude Medical. – Source TradeTheNews.com
News: ABT FDA expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects - Source TradeTheNews.com
Time: Tuesday, March 06, 2018 13:58
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ABT - Abbott Laboratories
Sector: Healthcare - Industry: Medical Devices
Abbott Laboratories is a health care company that manufactures medical devices, blood glucose monitoring kits, nutritional healthcare products, diagnostic products and equipment, and branded generic drugs.