By Suzanne Hodsden
St. Jude Medical announced the launch of a U.S. IDE clinical trial of its St. Jude Medical Masters HP Series 15 mm mechanical heart valve in pediatric patients. Participants in the HALO trial will be children for whom currently approved valves are not a feasible treatment and therefore have no other options.
The CDC reports that nearly 40,000 babies born in the U.S. each year will suffer from some form of congenital heart defect, and 25 percent of these defects will be critical enough to require surgery within the first year.
While adults requiring valve replacement have a number of options, children under the age of five in need of surgical intervention to correct a malfunctioning valve have far fewer — so surgeons often resort to using oversized valves that can cause dangerous complications and permanent damage. According to the St. Jude press release, there are currently no mechanical valves smaller than 16 mm in diameter approved by the FDA for use in small children.
“There is a profound need within the medical community for mechanical heart valve dedicated to our tiniest patients who can’t safely be implanted with the current range of valve sizes,” said Kirk Kanter, professor of surgery at the Emory University school of Medicine and surgical director of the Heart Transplant Program at Children’s Healthcare in Atlanta.
Last October, FDA Commissioner Margaret Hamburg gave a keynote address at the Second Annual Pediatric Surgical Innovation Symposium highlighting the particular challenges of pediatric device development.
Pediatric devices, said Hamburg, “require taking into account such factors as unpredictable growth and development, hormonal influences, anatomic and physiologic differences, and activity level. And scaling down an adult-size device for use in children brings potential mechanical challenges as well because thinner or shorter devices could change the product’s compositional properties.”
In the same speech, Hamburg called the Masters Series 15mm mechanical heart valve an achievement of collaboration within the medical community. The device, said Hamburg, was a direct result of a workshop held in January 2010 that generated feedback from manufacturers, clinicians, FDA staff, and academics.
The St. Jude press release stated that the clinical trial will evaluate the device’s safety and efficacy in pediatric cases requiring mitral valve replacement. Up to 40 different sites will collect data for use in an application for FDA approval. Currently, the device is available for clinical use only under the FDA’s “compassionate use” protocols.
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