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# Expanded Approval for St. Jude Medical Heart Valve
- URL: https://www.fdaweb.com/expanded-approval-for-st-jude-medical-heart-valve/
- Published: 2018-03-06T12:00:00.000Z
- Updated: 2026-09-14T23:27:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140910

FDA has expanded the approval of St. Jude Medical’s Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff to include a 15-mm valve size that is small enough to be used in newborn pediatric patients to treat heart defects. The rotatable, two-leaflet valve is designed for implantation in the aortic or mitral position, an [agency notice](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599676.htm?ref=fdaweb.com) says. It comprises two semi-circular discs that open and close in response to blood pressure changes during the heartbeat, similar to a patient’s own valve, it says. Thedevice was first approved in 1995 for patients with a diseased, damaged or malfunctioning aortic or mitral heart valve. It is also approved for use in replacing previously implanted aortic or mitral prosthetic heart valves.

Expanded approval was based on 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 after one year the probability of survival was 69% and the probability of not experiencing a valve-related adverse event was 67% for those implanted with the device, FDA says.