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| The Medical Masters HP Series 15 mm mechanical heart valve (left) compared to an adult-sized heart valve--Courtesy of St. Jude Medical |
St. Jude Medical ($STJ) is starting a trial for a device that it hopes will be the smallest FDA-approved pediatric mechanical heart valve. The device is only 15 mm in diameter; that's roughly equivalent to the length of a staple.
The U.S. Congress helped to encourage pediatric medical devices with the passage of a related law in 2007; and the FDA held a workshop in 2010 on the need to develop products for this patient population. St. Jude said the notion of conducting a pivotal trial for this pediatric heart valve, the Masters HPTM Series 15mm mechanical heart valve, came out of that FDA workshop.
This pediatric valve is currently available for emergency or compassionate use in the U.S. But fully approved treatment options for pediatric patients in need of mitral valve replacement are nonexistent, the company said. Each year in the U.S., 35,000 babies are born with congenital heart defects, some of whom will eventually require surgical valve replacement.
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| Kirk Kanter |
"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, 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, said in a statement. "This small valve represents a big step forward in helping cardiovascular surgeons provide our patients the optimal level of care."
The HALO trial for the heart valve will enroll pediatric patients in need of a mitral valve replacement at 40 U.S. sites; it's intended to support FDA approval. These patients could not be implanted with the current range of approved valve sizes without inducing risks such as suboptimal placement that can disrupt hemodynamics and damage to surrounding tissue that can lead to poor blood pressure and potential heart blockage.
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| Mark Carlson |
"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," Dr. Mark Carlson, VP of global clinical affairs and CMO at St. Jude, said in a statement.
- here is the release