The FDA has given a conditional investigational device exemption to Edwards Lifesciences to initiate the TRANSFORM trial, a prospective, multicentre study that will evaluate the Edwards Intuity valve system.
According to a company release, the TRANSFORM trial is the first US clinical trial of a rapid deployment system for surgical aortic valve replacement (AVR) procedures. The Edwards Intuity valve system, which consists of a bovine pericardial heart valve and novel balloon-expandable frame, is designed to facilitate small incision surgery and rapid valve deployment with the goal of enabling faster procedures.
“This new valve platform is designed to provide a number of patient benefits, and we look forward to learning how a smaller incision and more rapid valve implantation may result in reduced operative time and improved patient outcomes,” said Glenn Barnhart*, executive director and chief, Cardiac Surgical Services at Swedish Heart and Vascular Institute in Seattle, Washington, USA.
The TRANSFORM trial will study the safety and effectiveness of the Edwards Intuity valve system in a single arm study that will follow standard heart valve guidance and use historical controls.
“The Edwards Intuity valve system is based on the design of our proven market-leading surgical valves, and includes a novel delivery system designed to enhance control, accuracy and simplicity throughout the implantation,” said Donald E Bobo, Jr, corporate vice president, heart valve therapy. “This innovative platform was developed with key insights from leading surgeons who share our commitment to the continued advancement of therapeutic options for their patients.”
The Edwards Intuity valve system is an investigational device not yet available commercially in the United States.
*Glenn Barnhart provides paid educational consulting services to Edwards for heart valve technologies and training.