Le Lézard
Classified in: Health
Subject: TRI

Laplace Interventional Inc. Announces Successful First in Human Procedure in Early Feasibility Study of its Transcatheter Tricuspid Valve Replacement Device


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


These press releases may also interest you

at 13:00
Mallinckrodt plc, a global specialty pharmacy company, today announced that submissions for its 2024 Extracorporeal Immunomodulation Award (EIA) will open on 13 April 2024 during the 50th Annual Meeting of...

13 avr 2024
Experts from NYU Langone's Department of Neurology present their latest clinical findings and research discoveries at the American Academy of Neurology (AAN) 2024 Annual Meeting, April 13 to 18, in Denver....

13 avr 2024
MyAdvisor, a holistic wellness technology company, has been awarded the 2023-2024 Platinum Level Bell Seal...

13 avr 2024
Biohaven's first-in-class Molecular Degrader of Extracellular Proteins (MoDEtm) technology targeting IgG removal, BHV-1300, was selected for an oral presentation at AAN highlighting its novel mechanism of action and the latest preclinical data...

13 avr 2024
On Apr. 11, 2024, VITAL HealthCare, one of the 5 core business divisions of the VITAL Group, marked a stunning debut at the 89th China International Medical Equipment Fair (CMEF) in Shanghai. Drawing on the Group's core competence in R&D and its...

12 avr 2024
The report titled "STD Testing Market by Type (Blood Tests, Lumbar Puncture, Swab Tests), Product Type (Instruments, Reagents & Kits), Test Settings, Indication, End-user - Global Forecast 2024-2030" is now available on 360iResearch.com's offering,...



News published on and distributed by: