Laplace TTVR System’s EFS Begins With FIH Procedure to Treat Tricuspid Regurgitation

February 26, 2024—Minnesota-based Laplace Interventional announced the completion of its first-in-human (FIH) procedure with the Laplace transcatheter tricuspid valve replacement (TTVR) system.

Laplace Interventional’s TTVR system is intended to be used for reduction of tricuspid regurgitation (TR) in adults who have severe or more symptomatic TR despite medical therapy and who have been determined to be appropriate for TTVR.

The FIH procedure was conducted under an early feasibility study (EFS) clinical protocol approved by the FDA intended to understand the safety and technical feasibility of the Laplace TTVR system.

Thomas Waggoner, DO, and George Makdisi, MD, from US Heart and Vascular Institute at Tucson Medical Center (TMC) performed the procedure. Pradeep Yadav, MD, from Piedmont Heart Institute in Atlanta, Georgia, was also present during the case as a clinical proctor. The patient was discharged from the hospital and is recovering, noted the company.

“TMC is focused on providing leading-edge cardiac care to our patients by bringing advanced minimally invasive technologies to our patients,” commented Dr. Waggoner in the company’s press release. “We are proud to be the first medical center in the world to successfully implant a patient with Laplace Interventional’s cutting-edge new technology to treat TR. Thanks to the FDA’s dedication to the EFS Program, we are able to offer our patients new options for TTVR as early as possible through studies such as this.”

Dr. Yadav added, “The team at Laplace Interventional has developed an incredibly easy-to-use TTVR system. I can see this procedure to be readily learnt by physicians and Laplace’s technology to be routinely adopted across the world potentially improving the lives of several million patients who need a treatment.”

Laplace Interventional’s TTVR system is approved for investigational use in the United States and limited by Federal law to investigational use only, advised the company.