First Bileaflet Valve: St. Jude Medical Inc. Start-Up

Abstract

Early in 1979, St. Jude Medical visited our facility at General Atomic to discuss a patent, Possis Z., US 4,078,268 Heart Valve Prosthesis, to be manufactured from titanium metal and coated with carbon. After a short discussion, they realized it would not be possible. Instead, I praised the bileaflet design and suggested General Atomic might help them on a redesign but only with a strict “hold harmless” agreement and further advised that General Atomic’s carbon technology was patented, confidential, and proprietary. The final understanding was General Atomic would undertake the task at no cost, provided should the project achieve its objective, St. Jude would purchase the carbon components from General Atomic’s Medical Products Division. Although St. Jude Medical persisted in pursuing a license, we proceeded on an OEM basis using validated processes and protocols to provide components to be assembled by St. Jude Medical. It was agreed further that St. Jude could view the processing under a strict confidentiality agreement.