Food and Drug Administration (FDA) approves a pea-sized device named Amplatzer Piccolo Occluder to be used for the treatment of infants with holes in their hearts on Monday 14 January 2019.
Amplatzer Piccolo Occluder device is one of the smallest complex medical devices to be ever invented. This is the world’s first device that will be used to close holes in the hearts of premature and newborn babies.
Amplatzer Piccolo Occluder can be used in tiny babies weighing as little as 2 pounds (1 kg). This device is implanted in babies using a minimally invasive procedure.
All the babies are born with a small hole in their heart. This hole is a congenital heart defect called patent ductus arteriosus (PDA), which is potentially a life-threatening condition. This hole allows the flow of oxygen-rich blood from the mother to the fetus' body.
For most infants, the hole closes after delivery. But in some premature babies, this hole fails to close. As a result, babies have difficulty in breathing and suffer from many other complications.
A trial was conducted with hundreds of patients, which resulted in the approval of this device. The idea behind Amplatzer Piccolo Occluder is to reduce the risks of life-threatening complications and allow doctors to confidently treat these tiniest patients.
Amplatzer Piccolo Occluder is manufactured by Abbott Laboratories. Abbott is an US-based pharmaceutical company that manufactures health care products and devices.
Michael Dale, vice president of Abbott's structural heart business said, "Piccolo is a critical advancement in the standard of care for the most vulnerable of premature babies who may not be able to undergo surgery to repair their hearts.”
Dale also said that "Our mission is to develop life-changing technology to help people live better lives through improved health. This approval is another important step toward achieving our mission for the patients and physicians we serve."
“The Piccolo is threaded into the heart using a catheter that runs through the femoral vein in the thigh. That avoids a taxing surgery for the undersized patients, who are often on ventilators” said Evan Zahn, principal investigator for the study that led to FDA approval.
Zahn also stated that “We’ve never had anything like this, a device from a major medical manufacturer that was specifically designed with these tiny, really at risk, very fragile babies in mind. They are incredibly frail, fragile and at risk for terrible morbidity and mortality.”
The already existing treatments for PDA involves doctors performing open-heart surgeries to close the holes in the heart. This procedure is harmful to perform on infants and poses many risks.
Hence, there was a requirement for some alternative and safe treatment. According to the company, Amplatzer Piccolo Occluder is one such device which can successfully treat these holes without posing any risks.
Abbott will expand their availability of Amplatzer Piccolo Occluder to medical centers once the required training is provided.
Amplatzer Piccolo Occluder is a step forward in the field of health and science. The company has not yet announced the price for the device. The company claims that Amplatzer Piccolo Occluder will surely change lives for the better for newborns.