4C Medical Plans First Early Feasibility Study For An Implantable In Japan
4C Medical plans to conduct both an early feasibility study and the pivotal trial for its mitral regurgitation treatment device simultaneously in Japan, the US and Canada. The company says the study is the first early feasibility study in Japan for an implantable device.
You may also be interested in...
Starts & Stops: CardioFocus Studies HeartLight X3 In Persistent AF; IntraLink Spine Launches Trial Of Low-Back Device In Australia
Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from March 4 through March 17, including trial announcements from CardioFocus, Innovative Cardiovascular Solutions, IntraLink-Spine, Geneveve, Acutus, and Stereotaxis.
US firm 4C Medical Technologies is developing a unique solution to mitral regurgitation that sits outside the valve and takes advantage of the native valve's remaining function while preventing mitral regurgitation. The Minnesota-based start-up is currently funded by angel investors and "friends and family," but expects to raise a $15m Series B round in early 2018.
FDA released final guidance on granting investigational device exemptions for early feasibility medical device clinical studies Oct. 1. It grants manufacturers additional flexibility to change the clinical protocol in early feasibility trials, which are often conducted as the device’s design is still being finalized.