St. Jude Medical Announces 10-Year Clinical Data For Toronto SPV Stentless Tissue Heart Valve.

Business Editors/Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--Oct. 22, 2003

St. Jude Medical, Inc. (NYSE:STJ) today announced 10-year clinical data for its Toronto SPV(R) stentless tissue heart valve as part of a Post Approval Clinical Investigation required by the U.S. Food and Drug Administration (FDA). The heart valve received European CE Marking approval in August 1995, Canadian approval in December 1995, and FDA approval in November 1997.

The study followed 447 patients at six centers in the United States and Canada from July 1991 until October 2002. Key findings included the following:

-- Excellent durability. Ten-year clinical data showed that none

of the patients 65-years-and-older required a valve explant 

due to structural valve deterioration. Across all age groups,

88 percent of the patients did not require a valve explant.

-- Excellent patient valve-related survival rates. Approximately

98 percent of patients were free from valve replacement

related deaths after one year and almost 95 percent after nine

years. Other recent research has shown stentless valves to

have a statistically significant survival advantage over

conventional stented tissue valves.(1,2)

-- Excellent clinical performance. More than 98 percent of the

study's patients were classified as NYHA (New York Heart

Association) Class I or II at their nine-year postoperative

visit. This standard measures the patient's own assessment of

symptoms, as well as clinical benefits they've experienced

from heart valve replacement, with rankings ranging from Class

I (optimal) to Class IV. Prior to valve implant surgery, 55

percent of the patients were in NYHA Class III or IV. The

percentage of patients in NYHA Class I and II combined

remained constant over the course of the follow-up period.

The data also showed, on average, a statistically significant

improvement in left ventricular (LV) mass regression between

the early and late postoperative visits, which was maintained

throughout the 10-year study. LV mass regression is the

reduction in size of the heart's left ventricle, which is

often enlarged due to aortic valve disease or aortic stenosis

(narrowing), making it more difficult for the heart to pump

blood effectively.

-- Excellent hemodynamics. The Toronto SPV(R) valve's hemodynamic 

performance was maintained over the study's 10-year period.

The data showed that patients experienced a statistically

significant decrease in pressure gradients (the force required

to push blood through the valve) in all valve sizes between

the early and late postoperative visits. Patients also

benefited from statistically significant increases in

effective orifice area (EOA - the area of the valve's opening

for blood flow).

The Toronto SPV(R) stentless valve was developed at the University of Toronto and the Toronto General Hospital by Tirone E. David, M.D.

"In developing the Toronto SPV(R) valve, my initial goals were to improve hemodynamic performance and extend durability over conventional stented tissue valves," said Dr. David. "Results from this study show excellent 10-year data for the Toronto SPV(R) valve in both of these areas, bringing important benefits to heart valve patients."

St. Jude Medical also offers the Toronto Root(TM) stentless tissue valve, building on the highly successful design of the Toronto SPV(R) valve. This valve is used in procedures where aortic root disease accompanies valve disease and incorporates the Company's proprietary BiLinx(TM) anticalcification technology, designed to reduce calcification on both the aortic wall tissue and the aortic leaflets. The Toronto Root(TM) valve was launched in Europe in September 2002 and is currently in U.S. Investigational Device Exemption (IDE) trials, as well as Canadian clinical trials.

St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value.

(1) Rao V, et al. A Novel Comparison of Stentless Versus Stented Valves in Small Aortic Root. J Thorac Cardiovasc Surg 1999; 117:431-8.

(2) Del Rizzo DF, et al. Midterm Survival of Stented Versus Stentless Valves: Does Concomitant Coronary Artery Bypass Grafting Impact Survival?. Semin Thorac and Cardiovasc Surg 13 (suppl 1):148-155, 2001