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Date: November 25, 1997
FOR IMMEDIATE RELEASE 
Contact: FOOD AND DRUG ADMINISTRATION, Sharon Snider:(301)827­6242
Broadcast Media:(301)827­3434, Consumer Inquires  (800) 532­4440

FDA Approves New Type of Heart Valve

The device is a porcine tissue valve manufactured by St. Jude Medical, Inc., of Minneapolis, Minn. The valve employs new technology that eliminates the use of a stent, unlike other tissue valves previously approved by the FDA.

Heart valve stents are metal or plastic frames that hold the valve in the proper position. The new stentless Toronto SPV Valve is entirely supported by the patient's aorta.

"Since there is no stent apparatus to occupy valuable space, doctors can implant larger heart valves in patients, which should improve blood flow," said FDA Lead Deputy Commissioner Michael A. Friedman, M.D. "Stentless tissue valves more closely resemble the natural heart valve. They offer patients who need aortic valve replacement another important option for treatment."

Until now, people needing heart valve replacement surgery could receive allografts (human valves harvested from cadavers), mechanical valves, or stented porcine or bovine tissue valves.

While allografts generally last longer than other tissue valves, they are in short supply.

Approval of the new stentless tissue valve was based on a review of safety and effectiveness data submitted by the manufacturer and on the recommendation of the Circulatory System Devices Panel of FDA's Medical Devices Advisory Committee, which met in September to review the valve.

St. Jude Medical conducted a five year clinical study in which the valve was implanted in approximately 600 patients age 33 to 93 at hospitals in the United States, Canada, and the United Kingdom. Seventy five percent of the patients were 60 and older. Patients were followed an average of two years, with some followed up to five years. The study showed that the new valve was safe and provided good blood flow.

FDA is requiring the company to conduct a post marketing study to assess the long term safety and effectiveness of the device.