FDA Clears Use of Electrosurgical Device in Pediatric Patients

JustRight Surgical, LLC, a pediatric medical device company, has received FDA clearance for specific use of their 3mm vessel sealing system in pediatric surgery.

To achieve the additional clearance from the FDA, JustRight subjected its 3mm vessel sealer through rigorous testing, according to the company. The final data was presented at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) clinical congress in May. 

The sealer was shown to be 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 and was therefore determined to be safe to use in the smallest patients without risk of damaging critical, adjacent structures.

Company achievements have included development a 5mm stapler using the classic titanium wire staple in a clinically accepted “B” shape and the 3mm vessel sealer. Its devices, many of which are five to nine times smaller than previously available, are currently in use for general and thoracic procedures in more than 100 children’s hospitals in the U.S. and Europe.

“Pediatric surgeons have been requesting ‘right-sized’ surgical instruments and technologies for years,” according to Russ Lindemann, president and CEO. “This pediatric indication for use of vessel sealing is the first of its kind.”

All of JustRight Surgical’s products are designed and manufactured in the United States.