St. Jude Medical, FDA Announce New Clinical Trial to Treat Congenital Heart Defects

St. Jude Medical Inc. today announced the launch of the ADO II AS (AMPLATZER Duct Occluder II Additional Sizes) pediatric clinical trial. The U.S. investigational device exemption (IDE) clinical trial will evaluate the safety and effectiveness of the St. Jude Medical AMPLATZER Duct Occluder II AS (ADO II AS), a first-of-its-kind device specifically designed for closure of the small patent ductus arteriosus (PDA). St. Jude Medical now has two ongoing U.S. cardiology IDE clinical trials for pediatric patients. In 2014, the company launched the HALO trial to evaluate the safety and effectiveness of the SJM Masters HP Series 15mm mechanical heart valve, the smallest pediatric mechanical heart valve in the world.
 
Congenital heart disease (CHD) is the most common cause of major congenital anomalies, representing a major global health challenge. Every year CHD affects 1.35 million babies worldwide. Nearly 25 percent of babies with a congenital heart defect require surgery during their first year.
 
“The patients who would be eligible for this study are the tiniest and most fragile we care for—severely premature newborns who in many cases are critically ill from the presence of a patent ductus arteriosus (PDA),” said national investigator Dr. Evan Zahn, director of the Guerin Family Congenital Heart Program in the Cedars-Sinai Heart Institute and Department of Pediatrics at Cedars‐Sinai Medical Center in Los Angeles, Calif. “The AMPLATZER Duct Occluder II AS will provide an experimental option to surgery. Surgery has many risks in this delicate population and a minimally invasive approach is desperately needed for this fairly common and often quiet serious problem.”
 
Despite the large number of babies worldwide born with CHD, many children are treated with adult-sized devices, which may not be optimal for their tiny hearts. St. Jude Medical and the U.S. Food & Drug Administration (FDA) have long recognized the need for solutions and educational resources to support pediatric patients.
 
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. In collaboration with the FDA and top congenital heart disease experts, St. Jude Medical is addressing the unique challenges of developing, evaluating and bringing to market devices intended for pediatric use.
 
With more than 17 years of demonstrated clinical experience, the AMPLATZER family of occluders is the most studied transcatheter cardiac defect closure devices in the marketplace today. Adding to this body of clinical data, specifically for pediatrics, the ADO II AS IDE trial will enroll a maximum of 50 patients at up to 10 sites nationwide. Patients in the trial will fall within two study groups:

• 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.
 
“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.
 
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.
 
Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular.