Picard Medical to Begin Rollout of FDA-Cleared Accessory for its SynCardia Total Artificial Heart
TUCSON, Ariz., Jan. 06, 2026 (GLOBE NEWSWIRE) -- 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.
"Patient safety and quality of life are central to everything we do," said Steve Langford, Senior Clinical Specialist at SynCardia Systems. "This enhancement reflects our ongoing commitment to practical improvements that support confidence and ease of use for both patients and clinicians."
All SynCardia sales and clinical staff have completed the required training in advance of the rollout. SynCardia will work directly with hospital and clinical teams to provide training materials, implementation guidance, and support for existing patients as appropriate.
About Picard Medical, Inc.
Picard Medical, Inc. is the parent company of SynCardia Systems, LLC ("SynCardia"), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart ("STAH"), an implantable system that assumes the full functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the SynCardia Total Artificial Heart is the most widely used and extensively studied artificial heart in the world. For more information, please visit https://www.syncardia.com.
References
1Cold Products Company, a part of Dover (NYSE: DOV) and a leading manufacturer of connection technologies used in liquid cooling of electronics.
Forward-Looking Statements
This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company's expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.
Contact:
Investors
Eric Ribner
Managing Director
LifeSci Advisors LLC
[email protected]
Picard Medical, Inc./SynCardia Systems, LLC
[email protected]
General/Media
Brittany Lanza
[email protected]
