FDA approves closure device for patent ductus arteriosus
Abbott announced that the FDA approved a closure device for the treatment of premature babies with patent ductus arteriosus who are nonresponsive to medical management.
The Amplatzer Piccolo occluder is the first medical device that can be implanted in babies that weigh as little as 2 lb, according to a press release from the company.
“I am certain that this minimally invasive procedure will become the standard of care in the near future,” Shyam K. Sathanandam, MD, FSCAI, medical director of the invasive cardiac imaging and interventional catheterization laboratory at Lebonheur Children's Hospital in Memphis, told Cardiology Today’s Intervention. “It has been over 80 years since the first [patent ductus arteriosus] surgery was performed. We still do not have consensus in how to manage this very common condition found in the premature babies. This therapy is likely to change all that. I am certain that this procedure will become the mainstay therapy for thousands of premature babies.”
The wire mesh device self-expands and is inserted through a small incision in the leg through the aortic or pulmonary artery. Once inserted, it is guided through vessels to the heart, where it seals the opening, according to the press release. The device can be retrieved and redeployed for optimal placement. Due to the minimally invasive procedure, many of the premature babies who are critically ill can be weaned from artificial respirator support shortly after the procedure.
The FDA approval of this device was supported by results of the ADO II AS trial, which evaluated the device in 50 patients with patent ductus arteriosus who were older than 3 days. Efficacy and safety of the device was further supported by 150 more patients under a continued access protocol, according to the press release.
“This newly concluded FDA trial established that this procedure is feasible in children as small as 700 grams in size and is safe to perform,” Sathanandam told Cardiology Today’s Intervention. “Therefore, this minimally invasive procedure is likely to impact the survival and outcomes of nearly 15,000 children born prematurely in the United States each year. This is almost a public health problem for which we now have an elegant cure.”
Disclosure: Sathanandam reports he is a proctor and consultant for Abbott.