JustRight Surgical® first company to receive FDA clearance for use of device in pediatric patients
LOUISVILLE, Colo., June 29, 2016 /PRNewswire/ -- JustRight Surgical, LLC, the pediatric medical device company, has 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 2016.
The 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 was therefore determined to be safe to use in the smallest patients without risk of damaging critical, adjacent structures. The company’s devices are five to nine times smaller than previously available.
“Pediatric surgeons have been requesting ‘right-sized’ surgical instruments and technologies for years. 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,” said Russ Lindemann, president and CEO of JustRight Surgical. “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 and they are currently in use for general and thoracic procedures in over 100 children’s hospitals in the U.S. and Europe. They are the only company in the world to have developed a 5mm stapler using the classic titanium wire staple in a clinically accepted “B” shape and a 3mm vessel sealer.
Founded in 2010, JustRight Surgical devices were developed under the guidance of domestic and international pediatric surgeons. In addition, this team of medical device professionals has an extensive patent portfolio with a record of developing breakthrough technologies that have transformed surgical procedures. JustRight Surgical exists to serve healthcare providers by developing precisely designed surgical instruments where access is limited and visibility is reduced, facilitating less invasive surgical techniques and ultimately reducing scarring, pain and hospital stay. All of their products are designed and manufactured in the U.S. www.justrightsurgical.com.
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SOURCE JustRight Surgical
