A minimum of 15 patients less than or equal to 2 KG (approx. 4.4 pounds)
A minimum of 25 patients greater than 2 KG
Designed to treat PDA—one of the most common of all congenital heart anomalies—the ADO II AS device conforms to the smallest ducts while achieving complete closure from a pulmonary or aortic artery approach. Data collected during the ADO II AS trial across all trial sites will be used to support a pre-market approval submission of the device to FDA. The ADO II AS device is currently approved for use in more than 50 countries outside the United States.
Ad Statistics
Times Displayed: 21862
Times Visited: 433 Stay up to date with the latest training to fix, troubleshoot, and maintain your critical care devices. GE HealthCare offers multiple training formats to empower teams and expand knowledge, saving you time and money
“St. Jude Medical is continuing to build its legacy of innovation in the field of pediatric cardiology, and working to break the barriers to developing new CHD treatments so more children’s health conditions can be properly addressed,” said Dr. Srijoy Mahapatra, vice president of clinical, medical and scientific affairs at St. Jude Medical. “We are passionate about helping kids thrive, along with creating medical solutions that save and improve their lives.”
Building on the Momentum of the HALO IDE Clinical Trial
The other pediatric clinical trial from St. Jude Medical is evaluating the safety and efficacy of the SJM Masters HP Series 15mm mechanical heart valve, the smallest pediatric mechanical heart valve in the world. In the United States 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 cannot be repaired and will require surgical valve replacement. The HALO IDE trial is enrolling 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 HALO IDE trial stems from a new approach to the design, evaluation and regulatory approval of pediatric heart valves that emerged from a FDA-led workshop in 2010 organized in response to the pressing need to develop products for this patient population. During the 2nd Annual Pediatric Surgical Innovation Symposium, former FDA Commissioner Dr. Margaret A. Hamburg cited the St. Jude Medical pediatric heart valve as an example of what collaboration can achieve when industry, FDA staff, clinicians and academics come together to support pediatric medical device development.
About We Heart Kids™ Initiative from St. Jude Medical
At St. Jude Medical, we are inspired by kids living with congenital heart disease and their heroic families who never give up hope. That is one reason we are proud to be a market leader in the research, design and development of electrophysiology and interventional cardiology solutions for pediatric patients worldwide. Through the We Heart Kids initiative, St. Jude Medical partners with patient advocacy groups globally to help provide information and access to high-quality pediatric care in underserved communities. To learn more about our We Heart Kids initiative and our commitment to pediatric cardiology, please visit sjm.com/weheartkids.
