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First Human Procedure in Early Feasibility Study of Laplace Interventional Inc.'s Transcatheter Tricuspid Valve Replacement Device Proves Successful

Saturday, February 24, 2024

Laplace Interventional, headquartered in Minnesota, has reported the successful execution of its inaugural human procedure involving the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) system. Dr. Thomas Waggoner and Dr. George Makdisi of the US Heart and Vascular Institute at Tucson Medical Center (TMC) led the procedure, with Dr. Pradeep Yadav from the Piedmont Heart Institute, Atlanta, serving as a clinical proctor. This procedure, conducted under an Early Feasibility Study (EFS) clinical protocol sanctioned by the U.S. FDA, aimed to evaluate the safety and technical viability of the Laplace TTVR System. Following the procedure, the patient has been discharged and is currently recuperating.

Laplace Interventional's device is engineered to address issues associated with a malfunctioning tricuspid valve, particularly Tricuspid Regurgitation (TR), by replacing the faulty native valve. The TTVR system is designed for ease of use during procedures and can be delivered through the patient's vasculature, thus obviating the need for high-risk open-heart surgery.

TMC is committed to advancing cardiac care by integrating state-of-the-art minimally-invasive technologies. They proudly stand as the first medical center globally to successfully implement Laplace Interventional's groundbreaking technology for treating tricuspid regurgitation. Dr. Waggoner praised the user-friendly nature of Laplace Interventional's TTVR system, expressing optimism that it could be readily adopted by physicians worldwide, potentially benefiting millions of patients. TMC's dedication to innovation and compassionate healthcare drives their ongoing pursuit of new medical technologies.

Source: prnewswire.com

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