FDA Clearance for the First Suture-Like Mesh Fixation System for Hernia Repair
Via Surgical Ltd., a leading developer of hernia mesh fixation technologies, today announced that it has received FDA 510(k) clearance to commercialize FasTouch. FasTouch fixation system is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs. The FasTouch delivers uniquely designed suture-like fasteners that mimics traditional sutures by providing a closed and locked fixation loop around the mesh and the tissue. It provides superior fixation strength while minimizing the amount of implanted foreign body.
David Earle, MD, FACS, a member of the Via Surgical Medical Advisory Board and Associate Professor of Surgery, Tufts University School of Medicine, commented: "The FasTouch fixation device has the potential to dramatically reduce the need for full thickness abdominal wall sutures, possibly reducing postoperative pain and recurrence rates. I believe this is what has been missing for all these years."
"With the potential to reduce chronic pain complaints and a reduction in overall related costs, the FasTouch hernia mesh fixation system will help hernia surgeons everywhere to optimize patient outcomes," added Brian P. Jacob, MD, FACS, a member of the Via Surgical Medical Advisory Board and Regional Medical Director at AngelMD, an investment platform connecting physician investors and leading medical startups from all over the world.
Ofek Levin, the Founder and CEO of Via Surgical commented, "We are thrilled to have reached this value-creating milestone with the FDA clearance of FasTouch. Clinical interest in FasTouch is extremely high, surgeons are intrigued by the ability to deliver flexible and consistent suture-like fasteners combined with the ease of delivery of a standard tacking device. I believe the FasTouch will revolutionize the mesh fixation market."