US-based medical device firm St. Jude Medical has launched HALO US IDE Trial, which will assess the safety and efficacy of its 15mm mechanical heart valve.
St. Jude Medical Masters HP Series 15mm mechanical heart valve is said to be the smallest pediatric mechanical heart valve in the world.
St. Jude Medical global clinical affairs vice-president and chief medical officer Dr Mark Carlson said: "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.
"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."
According to the company, the trial 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 trial will include the enrolment of patients at up to 40 sites across the US.
Data collected from all trial sites is being used to support FDA approval of the 15mm mechanical heart valve, which is currently available only under "emergency or compassionate use" protocols.
Image: St. Jude Medical Masters HP Series 15mm mechanical heart valve pictured in comparison to an adult-sized mechanical heart valve. Photo: courtesy of Business Wire.