Abbott Proves That Size Does Matter

FDA approved a dime-sized mechanical heart valve from Abbott that is the first device of its kind small enough to treat newborns and infants in urgent need of a mitral or aortic valve replacement.

Abbott churned out an impressive number of new products last year, and our 2017 Medtech Company of the Year doesn't appear to be slowing down any. This week FDA approved Abbott's new pediatric mechanical heart valve, which is the first device of its kind that is small enough to be used in newborns and infants.

Previously, surgeons could only use a range of larger-sized valves to replace a pediatric heart valve, Abbott said, and larger valves are often not suitable given the smaller size of children's hearts. This dime-sized valve provides a new treatment option for the world's tiniest heart patients.

The company noted that congenital heart defects affect nearly 1% (about 40,000) births a year. This new device provides an option for children who have a poorly functioning valve that cannot be repaired, Abbott said.

"In my practice, I want to be able to provide a treatment option that works for a critically ill child when a larger-sized valve may not be suitable," said Kirk Kanter, MD, professor of surgery and director of the Heart Transplant Program at Children's Healthcare in Atlanta at Emory University School of Medicine, which was the top enrolling site for the trial that led to FDA approval of device. "The approval of this smaller pediatric mechanical heart valve provides surgeons with a much-needed option for treating these vulnerable, high-risk children."

Sadie Rutenberg, now 3, was the first infant enrolled in the clinical trial. She was only a few months old when her parents noticed she was breathing fast, stopped gaining weight, and was not eating well due to a congenital heart problem.

"When we were told that Sadie would need surgery right away, and was a candidate for a new clinical trial of a heart valve sized for her small body, we were willing to try it to hopefully save her life," said Lee'or Rutenberg, Sadie's father. "When the doctor came out of surgery and told us the surgery was a success - as a parent, it's a moment I'll never forget. The valve saved Sadie's life."

A mechanical heart valve mimics the valve of a healthy heart, opening and closing with each heartbeat, permitting proper blood flow through the heart.

"There's an urgent need for the smallest babies and children who need a suitable replacement valve in order to survive," said Michael Dale, vice president of Abbott's structural heart business. "Abbott's new mechanical pediatric heart valve is a life-changing technology for the smallest pediatric patients, giving them a better chance at a long, healthy life with a fully functioning heart."

The device is part of the Masters Series line, which now includes seven valves with diameter sizes ranging from 15 to 27mm. Initially approved in 1995, the valves have pyrolytic carbon leaflets and orifice rings, an 85-degree leaflet opening angle to improve flow and reduce turbulence, and a controlled torque rotation mechanism for rotation and intraoperative adjustment. A sewing cuff contains additional suture markers for more accurate placement.

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