Tucson Medical Center Implants First Patient with Novel Investigational Device
MINNEAPOLIS, Feb. 26, 2024 /PRNewswire/ — Minnesota based Laplace Interventional announced the successful completion of its first-in-human (FIH) procedure with its Laplace Transcatheter Tricuspid Valve Replacement (TTVR) system by Dr. Thomas Waggoner and Dr. George Makdisi from US Heart and Vascular Institute at Tucson Medical Center (TMC). In addition, Dr. Pradeep Yadav from Piedmont Heart Institute, Atlanta was also present during the case as a clinical proctor. The procedure was conducted under an Early Feasibility Study (EFS) clinical protocol approved by the U.S. FDA intended to understand the safety and technical feasibility of the Laplace TTVR System. The patient was discharged from the hospital and is recovering.
Laplace Interventional’s device is intended to replace the leaky native tricuspid valve to reduce or eliminate Tricuspid Regurgitation (TR). Laplace Interventional’s TTVR system is designed for procedural simplicity and is delivered through the patient’s vasculature without requiring a high risk open-heart surgery.
“TMC is focused on providing leading-edge cardiac care to our patients by bringing advanced minimally-invasive technologies to our patients. 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 tricuspid regurgitation. 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.” commented Dr. Waggoner.
“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.” commented Dr. Yadav.
“In Tucson Medical Center’s 80th year serving Southern Arizona, we’re incredibly proud of partnerships like this, that allow us to pursue innovation for our patients,” said Mimi Coomler, CEO of Tucson Medical Center. “Continued research and the pursuit of new medical technology allows us to continue our mission of providing exceptional health care with compassion.”
Laplace Interventional Founder and CEO, Ramji Iyer, PhD said ” On behalf of the Laplace team, I would like to congratulate Dr. Waggoner, Dr. Makdisi and the entire team at TMC, especially the TMC Cardiovascular Research team, on this incredible achievement and sincerely thank them for their dedication towards outstanding patient care. I am also very thankful to Dr. Yadav for his participation in the procedure as a clinical proctor. The successful completion of the FIH procedure in the US EFS study marks a significant milestone for Laplace’s technology and in understanding its potential to benefit a significant number of patients with tricuspid regurgitation.”
Caution: Laplace Interventional’s TTVR System is approved for investigational use in the United States and limited by Federal (or United States) law to investigational use only.
Note: Laplace Interventional’s TTVR System is intended to be used for reduction of TR in adults who have severe or more symptomatic TR despite medical therapy and who have been determined to be appropriate for transcatheter tricuspid valve replacement.
For more information, contact:
Laplace Interventional, Inc.
[email protected]
SOURCE Laplace Interventional
