LOUISVILLE, COLORADO, May 10, 2021 (GLOBE NEWSWIRE) -- Bolder Surgical today announced expanded indication to the FDA 510(k) clearance for the CoolSeal™ Trinity 5 mm Laparoscopic Vessel Sealer, Divider, and Dissector to include surgical procedures for pediatric patients including infants, children, and adolescents.
CoolSeal Trinity is part of the Bolder Surgical’s vessel sealing portfolio of products designed for pediatric and adult surgery. The larger vessel sealing capacity and cutting functionality of CoolSeal Trinity complements the 3 mm CoolSeal Mini, providing pediatric surgeons with unprecedented device choices to streamline workflow and support patient outcomes.
Both CoolSeal Trinity and CoolSeal Mini are designed for minimally invasive surgery which is less traumatic to the body and generally reduces length of hospital stay, scarring and incidence of infection.
Mathias Bruzoni, MD, of the Lucile Packard Children’s Hospital at Stanford said, “after using the Bolder Surgical 3 mm vessel sealer for many years, I’ve started using CoolSeal Trinity. I appreciate the dissection capability, the precision, and the speed. I really want it for most cases that involve vessel sealing and dissection.”
According to Bolder Surgical President and CEO Robert Kline, “With this new indication for Trinity, Bolder is proud to see the expansion of its advanced technologies to better serve the full range of pediatric patients. It is another step in our vision to create surgical innovations that benefit all patients including adults.”
About Bolder Surgical
Bolder Surgical was founded with the mission to elevate surgical expectations. Leveraging an expertise in energy delivery and precision surgical devices, the company delivers solutions to give surgeons options they’ve never had, optimizing workflow while allowing for minimal surgical impact on every patient. Bolder Surgical has reinvented vessel sealing with CoolSeal continuing the company’s legacy of innovation. Bolder Surgical was the first and only company to acquire FDA clearance for a 3 mm pediatric vessel sealer, and its mechanical stapler is the only 5 mm stapler on the market. Manufactured in the US, Bolder Surgical’s products have been adopted at hundreds of hospitals throughout the world.