Early Feasibility PRELUDE Study Begins for Caisson's TMVR System

October 11, 2016—Caisson Interventional, LLC recently announced the commencement of the early feasibility PRELUDE study, which is being conducted under an investigational device exemption (IDE) to provide initial data on the safety and performance of the Caisson transvascular mitral valve replacement (TMVR) system. The fully percutaneous TMVR implant is designed as a functional replacement in a diseased, damaged, or malfunctioning mitral valve.

Mathew R. Williams, MD, and his team from the Heart Valve Center at NYU Langone Medical Center in New York, New York, conducted the first enrollments in the PRELUDE study. The team successfully implanted three patients with the Caisson TMVR system. The US Food and Drug Administration (FDA) approved the IDE for the PRELUDE study under the Early Feasibility Study program for up to 20 patients at 5 centers, advised the company.

The Caisson TMVR system is approved for investigational use in the United States and is limited by federal law to investigational use only.