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.
With limited availability of valves that can suitably match the anatomy of children under the age of five, some surgeons are forced to implant larger valves in their smallest patients, which may lead to suboptimal placement that can disrupt hemodynamics, damage to surrounding tissue and an elevated risk of side effects such as poor blood pressure and potential heart blockage.
“There’s a profound need within the medical community for a mechanical heart valve dedicated to our tiniest patients who can’t safely be implanted with the current range of valve sizes,” said Dr. Kirk R. Kanter, professor of surgery at the Emory University School of Medicine and cardiothoracic surgeon and surgical director of the Heart Transplant Program at Children's Healthcare of Atlanta. “This small valve represents a big step forward in helping cardiovascular surgeons provide our patients the optimal level of care.”
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.
“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,” said Dr. Mark Carlson, vice president of global clinical affairs and chief medical officer at St. Jude Medical. “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.”
St. Jude Medical is a market leader in designing and developing electrophysiology and interventional cardiology solutions for pediatric patients worldwide. The company currently offers low voltage and high voltage pacemakers, ablation catheters and occluders to treat congenital heart defects for the pediatric population. In addition, St. Jude Medical is the most experienced mechanical valve company in the world, with more than 2 million valves implanted to date.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2014. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.