CardiAQ Uses Early-Feasibility IDE Paradigm To Bring Trans-Mitral Valve Device To U.S. Clinicians
This article was originally published in The Gray Sheet
Executive Summary
The California startup was able to leverage a new FDA process for early-feasibility device trials to launch a small U.S. study of its transfemoral and transapical transcatheter mitral valve implantation systems.
You may also be interested in...
Edwards Reinforces Transcatheter Mitral Program With CardiAQ Buy
Edwards says that CardiaAQ's mitral valve technology is complementary to its early-stage Fortis program, and that the two development programs will be combined.
FDA Finalizes Guidance On Early-Stage Clinical Trials
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.
Medtronic Transcatheter Pulmonary Valve Study Begins Under Draft FDA Feasibility Study Guidance
In granting IDE approval for a feasibility study of Medtronic’s Native Outflow Tract Transcatheter Pulmonary Valve, FDA followed a pathway laid out in a November 2011 draft guidance intended to streamline requirements for starting up and modifying early feasibility studies.