St. Jude Medical (NYSE:STJ) said today that it’s launching a clinical trial of a smaller heart valve implant for the underserved pediatric market.
The Halo U.S. investigation device exemption trial will study St. Jude’s Master HP valve, at 15mm the world’s smallest pediatric mechanical heart valve, according to a press release. It’s designed as a replacement for failing mitral valves in children with no other options, St. Jude said.
"There’s a profound need within the medical community for a mechanical heart valve dedicated to our tiniest patients who can’t safely be implanted with the current range of valve sizes," Dr. Kirk Kanter, of Atlanta’s Emory University School of Medicine, said in prepared remarks. "This small valve represents a big step forward in helping cardiovascular surgeons provide our patients the optimal level of care."
St. Jude said the Halo trial is slated to enroll patients at up to 40 U.S. sites ahead of a bid for FDA approval for the Master HD valve, which is available here only under an "emergency or compassionate use" exemption.
“The Masters Series 15mm mechanical heart valve was developed based on feedback we received from physicians and the FDA’s Office of Pediatric Therapeutics, who have expressed the need for a more suitable mechanical heart valve to offer pediatric patients for which there are simply no other options," added Dr. Mark Carlson, vice president of global clinical affairs and chief medical officer. "As a market leader in pediatric cardiology solutions, St. Jude Medical has the capability to develop devices that fill critical needs, and we will continue to look for more opportunities to create solutions for some of the biggest challenges facing pediatric surgeons and cardiologists today."