Laplace Interventional completes Trans-Jugular US Early Feasibility Study and adds Trans-Femoral approach

Laplace announces two major achievements: successful completion of patient enrollment in its US Early Feasibility Study (EFS)on its Trans-jugular (TJ) system and successful treatment of first two patients with their Trans-femoral (TF) delivery system.

PLYMOUTH, Minn., Oct. 24, 2025 /PRNewswire/ -- Minnesota based Laplace Interventional, a medical device company developing a transcatheter tricuspid valvereplacement (TTVR) system, announced today that it has successfully completed enrollment in its US Early Feasibility Study (EFS) on its Trans-jugular (TJ) system. To date, 41 patients have been enrolled in its TJ feasibility study with 37 patients in the US, 2 in Canada and 2 in Republic of Georgia. The feasibility study results will be presented by Dr. Kashish Goel, Interventional Cardiologist from Vanderbilt University Medical Center, Nashville, TN, USA on behalf of all study investigators at Transcatheter Cardiovascular Therapeutics (TCT) conference on 26thOctober, 2025 at 2pm (Pacific Time)under the title "The Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System: EFS Update"

Laplace also announced its successful addition of trans-femoral (TF) delivery system, which continues to use the same valve prosthesis, to its clinical feasibility study. Two patients were successfully treated using the TF approach by Irakli Gogorishvili, MD, and Gvantsa Dughashvili, MD at Healthycore in Tbilisi, Republic of Georgia, with support from structural heart experts from the United States, Kashish Goel, MD and Lucy Safi, DO.

Laplace Interventional's device aims to offer an improvement to the quality of life to patients worldwide diagnosed with Tricuspid Regurgitation (TR). Laplace Interventional is developing a prosthetic valve that is delivered through a minimally invasive procedure, either through a vein in neck or groin thereby reducing future complications in patients as compared to other valve replacement interventions.

"Our experience with the Laplace valve using the TJ approach has been extremely positive in the US EFS with multiple patients having more than a year of follow up. Laplace's novel design allows for us to treat a wide range of patient anatomies including some that may not be feasible with other TTVR devices. The successful completion of the first 2 TF cases broadens the capability of the device to treat even more patients, according to the physician's preference for access," said Dr. Goel.

Laplace Interventional Founder and CEO, Ramji Iyer, PhD said, "The completion of US EFS using the TJ approach as well as successful completion of 2 first-in-human (FIH) TF cases are both significant achievements for Laplace. I would like to thank all our clinical investigators and their clinical teams for their commitment to outstanding patient care. I would like to congratulate Dr. Goel, Dr. Safi, Dr. Gogorishvili, and Dr. Dugashvilifor successfully completing the first 2 TF cases with excellent results. We look forward to sharing our clinical experience and future plans using the Laplace TTVR system at TCT next week."

Caution: Laplace Interventional's device is in its development phase and is NOT approved or cleared by the FDA or any other regulatory body in any region of the world.

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SOURCE Laplace Interventional, Inc.