HHS NEWS

P97-38                       FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE        Sharon Snider:     (301) 827-6242
November 25, 1997            
                             Consumer Inquires  (800) 532-4440

              FDA APPROVES NEW TYPE OF HEART VALVE
     The Food and Drug Administration today approved a new type
of heart valve for adults with defective natural or prosthetic
aortic valves.  
     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.
                              ####