The HALO Trial represents a new opportunity for surgeons seeking a valve replacement for pediatric patients with no alternative approved treatment options
ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the launch of the HALO U.S. IDE Trial. The trial will evaluate the safety and efficacy of the St. Jude Medical Masters HPTM Series 15mm mechanical heart valve, the smallest pediatric mechanical heart valve in the world. The HALO 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.
In the U.S. alone, more than 35,000 babies are born each year with congenital heart defects, some of which will impact valve function to the point they’ll require surgical valve replacement. For many of these patients, mechanical heart valves can effectively mimic natural heart valves, opening and closing with each heart beat and permitting blood flow into the heart. While there are several replacement valves of varying size available for older patients, there are no prosthetic heart valves under 16mm in tissue diameter approved for standard use in newborns, infants and toddlers.
Help employers find you! Check out all the jobs and post your resume.
ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the launch of the HALO U.S. IDE Trial. The trial will evaluate the safety and efficacy of the St. Jude Medical Masters HPTM Series 15mm mechanical heart valve, the smallest pediatric mechanical heart valve in the world. The HALO 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.
In the U.S. alone, more than 35,000 babies are born each year with congenital heart defects, some of which will impact valve function to the point they’ll require surgical valve replacement. For many of these patients, mechanical heart valves can effectively mimic natural heart valves, opening and closing with each heart beat and permitting blood flow into the heart. While there are several replacement valves of varying size available for older patients, there are no prosthetic heart valves under 16mm in tissue diameter approved for standard use in newborns, infants and toddlers.
Help employers find you! Check out all the jobs and post your resume.
