Thursday June 30, 2016 0 comments
LOUISVILLE -- JustRight Surgical, LLC, a pediatric medical device company, announced it received FDA clearance for specific use of their 3mm JustRight Vessel Sealing System in pediatric surgery.
JustRight Surgical is the first and only company to secure clearance from the FDA for an electrosurgical device to be used specifically for pediatric patients. To achieve the additional clearance from the FDA, JustRight subjected its 3mm vessel sealer through rigorous testing.
The final data was presented at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) clinical congress in May.
The company said its JustRight 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 determined to be safe to use in the smallest patients without risk of damaging critical, adjacent structures.
JustRight said its devices are five to nine times smaller than previously available.
"Pediatric surgeons have been requesting 'right-sized' surgical instruments and technologies for years,” said Russ Lindemann, JustRight president and CEO.
“This pediatric indication for use of vessel sealing is the first of its kind. It further 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."
Demand for JustRight Surgical's instruments has been robust, the company said, and they are currently in use for general and thoracic procedures in more than 100 children's hospitals in the U.S. and Europe.
JustRight said it is the only company in the world to develop a 5mm stapler using the classic titanium wire staple in a clinically accepted "B" shape and a 3mm vessel sealer.