World’s Smallest Mechanical Heart Valve — Made In Minnesota — Approved By FDA

By Mary Divine
Pioneer Press, St. Paul, Minn.

WWR Article Summary (tl;dr) Teresa Tollefson is helping build the world’s smallest pediatric mechanical heart valve for children with heart defects.

Pioneer Press, St. Paul, Minn.

In a laboratory near Interstate 35E and Minnesota 36, Abbott Laboratories employee Teresa Tollefson peers through a microscope, dips a Q-tip in Isopropyl alcohol and gently swabs a ring the size of a dime.

First, she turns the microscope to its 7X setting. If she sees any anomalies in the pyrolytic carbon ring, she’ll bump up to 30X “for closer inspection,” she said.

Tollefson is helping build the world’s smallest pediatric mechanical heart valve for children with heart defects.

Recently approved by the U.S. Food and Drug Administration, the valve is the first deemed suitable for newborns and young infants.

It is the smallest mechanical heart valve available commercially in the world.

“It’s very gratifying, knowing that it’s a baby valve, and it could ultimately save a child’s life,” said
Tollefson, who has worked at the former St. Jude Medical manufacturing facility in Little Canada for 21 years.

“They are going to potentially have a full healthy life, and this device is going to give them that.”

The work is labor-intensive. Each 15-millimeter valve takes about two weeks to produce. Some of the parts must be hand-sewn into place.

SURGEONS’ REQUESTS
Officials at St. Jude Medical, which was acquired by Illinois-based Abbott in 2017, began making the miniature valves in 2012 at the urging of pediatric cardiac surgeons.

“We kept getting requests” ‘Boy, we could really use one of these for the smallest of the smallest children,’ so we’re taking our technology and applying it for infants,” said Rick Olson, divisional vice president of product development for Abbott’s structural heart business. “Before this, there was nothing available to them.”

Related News

Leave a Reply

Your email address will not be published. Required fields are marked *