St. Jude Medical starts U.S. trial of new pediatric heart valve

GLOBAL medical device company St. Jude Medical Inc. (NYSE:STJ) has launched the HALO U.S. IDE Trial to assess the safety and efficacy of the St. Jude Medical Masters HPTM Series 15mm mechanical heart valve, the smallest pediatric mechanical heart valve in the world currently available only under “emergency or compassionate use” protocols.

 

The HALO Trial of the Masters HP Series 15mm mechanical heart valve, pictured in comparison to an adult-sized mechanical heart valve, represents a new opportunity for surgeons seeking a valve replacement for pediatric patients with no alternative approved treatment options 

 

The HALO trial will enroll pediatric patients in need of mitral valve replacement but cannot be implanted with the current range of approved valves due to additional risks and have no alternative approved treatment options. It will cover patients from up to 40 sites nationwide. The data collected will be used to support FDA approval of the Masters Series 15mm mechanical heart valve.

 

Some surgeons are forced to implant larger valves in pediatric patients because of the limited availability of valves that match the anatomy of children under the age of five. In addition to suboptimal placement that can disrupt hemodynamics, this can cause damage to surrounding tissue and other side effects such as poor blood pressure and potential heart blockage.

 

According to Dr. Kirk R. Kanter, professor of surgery at the Emory University School of Medicine and cardiothoracic surgeon and surgical director of the Heart Transplant Program at Children's Healthcare of Atlanta, “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. This small valve represents a big step forward in helping cardiovascular surgeons provide our patients the optimal level of care.”

 

Dr. Mark Carlson, vice president of global clinical affairs and chief medical officer at St. Jude Medical, said that the Masters Series 15mm mechanical heart valve was developed based on feedback from physicians. The FDA’s Office of Pediatric Therapeutics also provided feedback and expressed the need for a more suitable mechanical heart valve to offer pediatric patients for which there are simply no other options. 

 

“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,” Dr. Carlson added.