Global medical devices company, St. Jude Medical ( STJ ), recently launched the HALO U.S. IDE Trial. The trial is essentially aimed at assessing the safety and efficiency of the St. Jude Medical Masters HPTM Series 15mm mechanical heart valve.
According to reports, more than 35,000 babies suffer from congenital heart defects. Many of them thus require mechanical heart valves to perform the function of natural heart valves. These mechanical valves open and close along with each heart beat, permitting sufficient blood flow into the heart of the patient.
While a wide range of replacement valves exist for older patients, there are no prosthetic heart valves currently available, for use in newborns, infants and toddlers.
Since there are limited valves available for children under the age of five, surgeons are often forced to unwillingly insert larger valves. These often lead to tissue damaging and multiple unwanted side effects such as blood pressure problems and potential heart blockage.
The HALO trial will enlist patients at up to 40 sites nationwide, 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 FDA approval of the Masters Series 15mm mechanical heart valve. Notably, the valve is currently accessible only under "emergency or compassionate use" protocols.
We currently await the outcome of the trial by St. Jude Medical, which if positive, will hold interesting long-term prospects for the treatment of heart abnormalities in newborns.
In our opinion, this particular product, once approved, should be a game-changer for St. Jude Medical. The technology will help address heart ailments in a sensitively-aged patient group, catering to specific needs in them that have not been fulfilled to date.
Moreover, the product - once sanctioned - will be a powerful addition to the company's expanding and innovative portfolio, and will subsequently drive significant top-line growth.
Currently, St. Jude has a Zacks Rank #4 (Sell).
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