Global medical-device company St Jude Medical (
www.sjm.com/corporate.aspx) recently launched the HALO Trial to asses the safety and efficiency of its Masters HPTM-series 15mm mechanical heart valve.
According to reports, more than 35,000 babies per year suffer from congenital heart defects, and many of them require mechanical heart valves to perform the function of natural heart valves; these mechanical valves open and close along with each heart beat, allowing sufficient blood to flow into the patient’s heart.
While a wide range of replacement valves exists for older patients, there are no prosthetic heart valves currently available for use in newborns, infants and toddlers.
Because there are few valves available for children under the age of five, surgeons are often forced to insert larger valves than is ideal; this often leads to tissue damage and unwanted side effects such as blood pressure problems and potential heart blockage.
The HALO Trial will enlist patients — at up to 40 sites nation-wide — who are in dire need of mitral valve replacement and cannot be implanted with valves over 16mm in ‘tissue diameter’. The data collected during the course of the trial will be used to back the application for FDA approval of the Masters 15mm mechanical heart valve.