JustRight Surgical gains additional FDA approval

LOUISVILLE — JustRight Surgical LLC in Louisville said Tuesday it has received additional clearance from the FDA for one of its electrosurgical devices, making it the first instrument cleared for use specifically for surgeries involving pediatric patients.

The JustRight Surgical Vessel Sealing System already had FDA approval and is being used in surgeries on adults and children. But questions have been posed on the safety of bulkier tools using high power to create the heat to cauterize tissue in children.

Company spokeswoman Patti Hoag explained that doctors have the choice to use whatever device they want to seal vessels in adults and children, and the FDA approved electrosurgical devices 15 years ago.

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This clearance, she said, says Just Right’s vessel-sealing device is safe to use in extremely tight or small spaces found in teens, children, infants and neonates.  The new, low-power vessel-sealing technology was found to permanently fuse vessels while using significantly less energy.

“This additional clearance will allow us to market the device as being safe for pediatric surgery,” Hoag said.

Russ Lindemann, president and chief executive of JustRight Surgical, said pediatric surgeons have been requesting “right-sized” surgical instruments and technologies for years.

“This validates the truly unique technical advancements made by our development team. … We are the only surgical-device manufacturer to focus solely on pediatrics. Now, surgeons and hospitals are recognizing the value we bring to caring for the smallest of patients.”

JustRight Surgical’s instruments are being used for general and thoracic procedures in more than 100 children’s hospitals in the United States and Europe. JustRight Surgical has the only 5-millimeter stapler using the classic titanium wire staple in a clinically accepted “B” shape along with the 3- millimeter vessel sealer.