An innovative delivery systems company for surgery and robotic procedures, Primequal, has received CE Mark for a new type of surgical applicator.
The Talent IH (inguinal hernia) is a surgical glue applicator that provides a strong mesh fixation during inguinal hernia surgery.
The company claims that because there’s no staples, tackers and stitches in use, the product allows patients to recover quickly.
David Weill, founder and CEO of Primequal, said: “Stitches take time and require training and skills.
“Tackers and staples are known to be painful and can lead to post-operation problems.
“Recently, the FDA announced that they would look into measures to address unacceptable risks with staples based on more than 40,000 accidents registered in seven years.
“Surgical glue is a safe and efficient replacement option, particularly combined with Talent IH.”
What is hernia surgery?
A hernia refers to an internal part of the body poking through a hole or weakening part of the abdominal muscle wall.
The most common type is inguinal hernia, which is a painful swelling or lump that forms in the groin or as an enlarged scrotum.
Mr Weill said: “Hernia repair is number one surgery in the world, with more than 20 million surgeries.
“This statistic led us to choose hernia as the first indication for our new technology.
“Interestingly, this is the same reason surgical glue manufacturers have concentrated their efforts to support the shift from stitches, staples and takers to surgical glue.
“We believe we are at the right place with the right product.”
What makes Talent IH unique?
Until now, the use of surgical glue in hernia surgery has been difficult due to the lack of an efficient applicator.
Primequal claims Talent IH is the world’s first versatile adhesive applicator kit and says it is easy to control due to its use of multiple glues, enabling the surgeon to deliver a precise dose with every click of the device.
The firm also says that it can fix multiple meshes, based on its accumulated skills as well as adapt to any surgical situation.
Mr Weill said: “Gaining CE Mark for Talent IH is a significant accomplishment for Primequal as this application required rigorous regulatory review against very high clinical and safety standards.
“It further demonstrates our ability to deliver innovative surgical products that provide superior benefits to clinicians and patients, particularly at a time when regulatory authorities are highlighting the higher risks and accidents often seen with surgical staplers.”
Addressing the shortcomings of current devices and techniques used as surgical glue for hernia surgery, Mr Weill says the glue used for surgery isn’t the problem, but “the lack of a safe and easy to use applicator for glue is a major issue.”
He added: “Surgical glues have been available for more than 20 years and recent publications have demonstrated their great ability to be used in the replacement of stitches, tackers and staples in many indications.
“Now Talent IH is available as the ‘game changer’ solution that will make a huge difference in accelerating the replacement of the old stitches, tackers and staples in most cases.”
What’s next for Primequal?
Primequal is currently evaluating different options for approval of the technology for additional indications.
One advanced application is to introduce a “game changer for wound closure.”
Mr Weills said: “The applications for our technology are wide, given its cost effective and unique dosing system.
“Included are all surgeries with glues, delivery of drug into tissues and specific organs, such as the brain or bones, but also aesthetic surgery with toxins and fillers, intra-muscular and intra-dermal injections and more.”
