FDA approves Boston Scientific’s cardiac devices

These devices represent entirely new platforms to treat heart failure and sudden cardiac death and are the result of a multi-year R&D effort to provide physicians enhanced clinical options for their patients. Cognis and Teligen are built on entirely new platforms, including device hardware, software and programming interface.

Both devices are said to offer a redundant hardware system called SafetyCore, which provides lifesaving shock therapy and basic pacing functionality in the unlikely event of a system error.

Poul-Erik Bloch-Thomson, KAS Gentofte Hospital, University of Copenhagen, Denmark, said: “When prescribing a high-energy device, I often had to make trade-offs among device size, battery longevity and features. The Cognis and Teligen devices eliminate those trade-offs without compromising therapy options.”