“VenTouch OUS Feasibility Study”
This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR.
Device - VenTouch System
The VenTouchâ„¢ System consists of a delivery tool with a pre-loaded implant (VenTouch device) and accessories, which include a sizing tool, PEMS, chamber positioning tool, and accessories kit with luer fitting, tubing clamp, and titanium plug. The VenTouch device is offered in 6 sizes, with 4 different sized inflatable chambers available. Please refer to the VenTouch Instructions for Use for and system details. The VenTouch device consists of three (3) inflatable silicone chambers attached to t ...read more on ClinicalTrials.org
Evaluation of The Minimally Invasive VenTouchâ„¢ System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study