News | Heart Valve Technology | November 06, 2018

First TriCinch Coil Tricuspid Repair Systems Implanted in U.S.

Early feasibility study will implant transcatheter tricuspid valve repair system in 15 patients at seven U.S. centers

First TriCinch Coil Tricuspid Repair Systems Implanted in U.S.

November 6, 2018 — 4Tech Inc. initiated its U.S. Early Feasibility Study of the TriCinich Coil System following U.S. Food and Drug Administration (FDA) approval, with the first two implantations at Piedmont Heart Hospital in Atlanta. The implantations were conducted by  Christopher Meduri, M.D., Vivek Rajagopal, M.D., and Mani Vannan, M.D. The study will evaluate the TriCinch Coil System in 15 patients across seven centers in the U.S.

“We are pleased to be the first center in the U.S. to implant the TriCinch Coil System,” said Meduri. “Both procedures went smoothly, and the device was easy to implant. Having a technology like the TriCinch Coil System in our structural heart toolkit allows us to treat a wide range of patients suffering from tricuspid regurgitation, who are at high risk for open heart surgery, in a safe and simple manner.”

The 4Tech TriCinch Coil System is a percutaneous direct annuloplasty device designed to reduce tricuspid regurgitation by means of tricuspid valve (TV) remodeling via a nitinol coil anchor that is tensioned by a nitinol stent in the inferior vena cava (IVC).

The device is being evaluated worldwide with a CE-Trial that has enrollment in both Australia and Europe.

Tricuspid regurgitation is a common condition that is age-related and difficult-to-manage, in which blood “backflows” into the right atrium. Today’s standard of care for TR is medical management. Surgical intervention is high-risk, with an in-hospital mortality for isolated TR as high as 37 percent1. Patients with TR and related complications result in substantial healthcare spending due to frequent rehospitalizations. Furthermore, TR leads to chronic renal failure and the need for end-stage dialysis. The combination of these negative outcomes results in a significant unmet need for a minimally invasive solution for TR.

For more information: www.4techtricuspid.com

Reference

1. Fender E.A., et al. Heart 2017;0:1–9. doi:10.1136/heartjnl-2017-311586

 

Related Content

LivaNova Receives FDA Clearance for Memo 4D Semi-Rigid Mitral Annuloplasty Ring
Technology | Annuloplasty Rings | June 15, 2018
LivaNova PLC announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Memo 4D semi-rigid...
Second Micro Interventional Devices Annuloplasty System Successfully Implanted
News | Annuloplasty Rings | October 30, 2017
Micro Interventional Devices Inc. (MID) recently announced the second successful implantation of its MIA (Minimally...
HAART 300 Aortic Annuloplasty Device Sees U.S. Pilot Launch, First Commercial Use
News | Annuloplasty Rings | July 05, 2017
July 5, 2017 — BioStable Science & Engineering Inc.
TITAN II Trial, Carillon Mitral Contour System, Cardiac Dimensions, Open Heart journal, functional mitral regurgitation, FMR
News | Annuloplasty Rings | July 20, 2016
New data from the TITAN II trial confirm the safety and efficacy of the Carillon Mitral Contour System in the treatment...
Mitralign Percutaneous Annuloplasty System, MPAS, CE Mark approval
News | Annuloplasty Rings | April 27, 2016
Mitralign Inc. announced its Mitralign Percutaneous Annuloplasty System (MPAS) has received CE mark approval from its...
Carillon mitral contour system, Cardiac Dimensions, functional mitral regurgitation, FMR, University Hospital Liepzig study
News | Annuloplasty Rings | February 24, 2016
A single-center study noted that treatment with Cardiac Dimensions’ Carillon Mitral Contour System resulted in...
Carillon mitral contour system, cost-effective, optimal medical treatment, OMT, TITAN, functional mitral regurgitation, FMR

Carillon mitral contour system image courtesy of Cardiac Dimensions Inc.

News | Annuloplasty Rings | September 10, 2015
The Carillon mitral contour system is projected to be a cost-effective treatment option when compared to a typical...
Overlay Init