U.S. Study of Smallest Pediatric Mechanical Heart Valve Starts

St. Jude Medical, Inc. has launched the HALO U.S. IDE Trial, designed to evaluate the safety and efficacy of the smallest pediatric mechanical heart valve in the world

Background

The St. Jude Medical Masters HPTM Series 15mm mechanical heart valve, lays claim to being the smallest pediatric mechanical heart valve in the world. Why this matters is that in the U.S. alone, more than 35,000 babies are born each year with congenital heart defects, some of which will impact valve function to the point they’ll require surgical valve replacement. While there are several replacement valves of varying size available for older patients, St. Jude says there are no such valves under 16mm in tissue diameter approved for standard use in newborns, infants and toddlers. This leaves surgeons sometimes forced to implant larger valves in their smallest patients, which may lead to suboptimal placement that can disrupt hemodynamics, damage to surrounding tissue and an elevated risk of side effects such as poor blood pressure and potential heart blockage.

In 2007, the U.S. Congress passed the Pediatric Medical Device Safety and Improvement Act to prompt development of medical devices designed and engineered specifically for the pediatric patient population. St. Jude Medical took on the challenge of designing a mechanical heart valve that could provide very young patients a chance of survival until they can be implanted with a larger, permanent valve implant they will carry with them the rest of their life.

So to the HALO IDE study which will enroll pediatric patients in need of mitral valve replacement who cannot be implanted with the current range of approved valves without additional risks and who have no alternative approved treatment options.

The HALO Trial will enroll patients at up to 40 sites nationwide with data collected across all trial sites being used to support FDA approval of the Masters Series 15mm mechanical heart valve, which is currently available only under “emergency or compassionate use” protocols.

Physician comments

“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,” said 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. “This small valve represents a big step forward in helping cardiovascular surgeons provide our patients the optimal level of care.”

Company comments

“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,” said Dr. Mark Carlson, vice president of global clinical affairs and chief medical officer at St. Jude Medical. “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.”

Source: Business Wire

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