Can The Man Who Built A Better Heart Valve Do It Again?

Sanuel A. Villafana is a bit of a departure from your usual medical entrepreneur. Forget lab coats or advanced degrees. Villafana, who prefers flashy suits and cuff links shaped like heart valves, earned his top diploma from Cardinal Hayes High School in the South Bronx. Ask about the diamond ring on his right hand, and he'll tell you he designed the setting for the 2.02-carat, investment-grade gem. "You could buy a house with this diamond," he adds. His Rolls-Royce and '47 Cadillac? "We like to have fun," he explains.

But don't let appearances fool you. Villafana, who is known as Manny in the industry, boasts a busy if mixed track record at starting up companies. In 1972, he founded Cardiac Pacemakers Inc., which was sold to Eli Lilly & Co. six years later for $127 million. In 1976, he founded St. Jude Medical Inc. In 1981, after seeing St. Jude's heart valve through four years of clinical trials in Europe, Villafana left under still-disputed circumstances.

Two years later, he co-founded GV Medical Inc., a laser-angioplasty company. In 1987, Villafana left that struggling company, which would lose $7.9 million in 1990, to start Helix Biocore Inc. Helix planned to offer cell-growing services to drug and biotech companies but eventually turned to the heart-valve market when cash grew tight.

'BEAUTIFUL.' This latest venture is a touchy subject with St. Jude CEO Lawrence A. Lehmkuhl, who calls Villafana's efforts at a comeback "nothing but hype." He groups Villafana with "the 30 others trying to develop mechanical valves. We'll be ready for him." As for Villafana's claim that he'll begin implanting heart valves in humans in Europe by the end of the year, Lehmkuhl says: "You can take anything and stick it in humans somewhere in the world."

Lehmkuhl, a former accountant, dismisses Villafana as "a salesman" who left St. Jude because he had misinterpreted Food & Drug Administration rules and implanted more valves in humans than he had permission to. This crisis, Lehmkuhl asserts, nearly led to the company's shutdown. Villafana calls the charge "totally incorrect" and says the board "begged" him to stay.

Whatever the case, Villafana does seem a gifted salesman. At a recent convention of heart surgeons in Washington, he was pitching his new valve to Walter Vancampenhoudt, St. Jude's former distributor in Belgium. After his presentation, complete with a prototype of the valve and photos, Villafana had a believer. "It's beautiful," Vancampenhoudt declares. "There's no doubt about its success."

But the key is what doctors think. "We take manufacturers with a grain of salt," says Carl Backer, a Chicago heart surgeon. "We read the scientific literature and know from our own experience." Ultimately, Villafana's valve will have to meet that difficult test.

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