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Picard Medical To Begin To Incorporate Additional Design Component Of FDA-Cleared Accessory, CPC1 "Connector Covers", Into SynCardia Total Artificial Heart Design

Benzinga·01/06/2026 13:05:59
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Picard Medical, Inc. (NYSE:PMI) ("Picard" or the "Company"), parent company of SynCardia Systems, LLC, maker of the world's first total artificial heart approved by both the U.S. Food and Drug Administration (FDA) and Health Canada today announced that it would begin to incorporate an additional design component of an FDA-cleared accessory, CPC1 "Connector Covers", into its SynCardia Total Artificial Heart (STAH) design that is intended to provide comfort during daily activities while reinforcing system safety and reliability.

Specifically, the CPC Connector Covers will offer an extra layer of protection over the metal release buttons that are found on the STAH CPC connectors which externally connect SynCardia Drivers to the two pneumatic drive cannulas of the STAH ventricles. The rollout is expected to be incorporated into standard clinical practice for patients in the U.S. beginning January 15, 2026.