St. Jude Medical received an investigational device exemption (IDE) from the FDA and is launching a U.S. trial of the Masters HP Series 15 mm pediatric heart valve. The device is the smallest mechanical heart valve in the world and will be tested as a last resort option for small children needing a mitral valve replacement.

Since the smallest valves available are 16 mm in diameter, patients with smaller anatomies often receive replacement valves larger than what would be optimally appropriate. Too frequently this leads to misconfigured placement, inappropriate blood flow, tissue damage, and other side effects.

Some details about what led to the development of the new valve:

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. With its legacy of innovation in the field of pediatric cardiology, St. Jude Medical was uniquely positioned to meet 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.

The launch of the HALO IDE stems from a new approach to the design, evaluation and regulatory approval of pediatric heart valves that emerged from an FDA led workshop in 2010 organized in response to the pressing need to develop products for this patient population. In a speech held in October 2014 the St. Jude Medical pediatric heart valve was cited by FDA Commissioner Margaret A. Hamburg, M.D., as an example of what collaboration can achieve when industry, FDA staff, clinicians and academics come together to support pediatric medical device development.

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

source：St. Jude Medical