Picard Medical 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 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. 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.
Picard Medical, Inc. is a holding company that owns a 100% interest in SynCardia Systems, LLC (SynCardia). SynCardia is a medical technology company that manufactures and sells the only United States Food and Drug Administration (FDA) and Health Canada-approved implantable total artificial heart (SynCardia TAH). The SynCardia TAH is a biventricular replacement device that consists of the SynCardia TAH implant, an external pneumatic driver that delivers precisely calibrated pulses of air to drive the implant, and drivelines that connect the driver to the implant. The SynCardia TAH implant is a system that consists of two independent artificial ventricles which are powered by an external pneumatic driver. Each artificial ventricle is made of a semi-rigid polyurethane housing and a rigid polyurethane base, with a four-layer flexible polyurethane diaphragm separating the blood chamber from the air chamber.
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Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.