FDA approves heart valve designed to grow with children

FDA approves pediatric pulmonary heart valve

The U.S. Food and Drug Administration approved the Autus Size-Adjustable Valve, according to Gulfcoastmedia’s report on an Oct. 1 FDA news release. The device is a surgically implanted pulmonary heart valve designed for pediatric patients.

Gulfcoastmedia described the action as FDA approval of the first heart valve designed to grow with children. The approval places the Autus Size-Adjustable Valve in focus as a pediatric-focused device in the pulmonary heart valve category.

Device details reported by Gulfcoastmedia

The reported device name is the Autus Size-Adjustable Valve. Gulfcoastmedia identified it as a surgically implanted pulmonary heart valve and stated that it is designed for pediatric patients.

The size-adjustable design is central to the FDA event reported by Gulfcoastmedia. The publisher’s headline characterized the valve as designed to grow with children, while its summary identified the device as a pulmonary heart valve for pediatric patients.

Relevance for medical device sales professionals

For medical device sales professionals following cardiovascular technologies, the FDA action is a regulatory milestone involving a surgically implanted device for pediatric patients. The event also concerns a pulmonary heart valve with a size-adjustable design.

• The FDA approved the Autus Size-Adjustable Valve.
• Gulfcoastmedia reported the approval from an Oct. 1 FDA news release.
• The device is a surgically implanted pulmonary heart valve.
• The device is designed for pediatric patients.
• Gulfcoastmedia described it as the first heart valve designed to grow with children.

Account discussions about this FDA event can distinguish the reported device category, surgical implantation, pediatric focus, and size-adjustable design. Gulfcoastmedia’s report attributes the approval and device description to the U.S. Food and Drug Administration’s news release.