Anchora Medical, an Israel-based medical device company, announced today that it has received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) to market its Su2ura® Approximation Device, an innovative, automated suturing device used in laparoscopic surgery, for the placement of interrupted or running stitches in soft tissue.
Today, standard laparoscopic suturing during Minimal-Invasive Surgery (MIS) is complex and technically challenging. Surgeons face altered depth perception, two-dimensional vision, a small working field, and use long instruments, where the needle driver is far from the surgeon’s hand, making precision suturing challenging.
The Su2ura® Approximation Device enables a simple, automated single-trigger operation that combines simplicity, strength, and durability of sutures during MIS. By simplifying the suturing procedure, the Su2ura® Approximation Device aims to shorten operation time, lower costs, reduce risks and improve clinical outcomes.
The proprietary, patent protected Su2ura® Approximation Device incorporates tiny stainless-steel smart anchors threaded on a surgical thread to create sutures seamlessly adjusted by the surgeon for precision suturing in small spaces. It is a sterile single-use device operated through a 5 mm laparoscopic port.
The Su2ura® device has been used in human trials, performing laparoscopic procedures and successfully closing primary umbilical hernia defects prior to mesh fixation. The surgeries are being performed in two medical centers.
Anchora’s CEO, Yoni Epstein, commented: “We are proud to receive FDA clearance for our novel Su2ura® Approximation Device which will set a new standard in the way laparoscopic and endoscopic suturing is performed during MIS. The FDA clearance signifies a critical milestone in our development and will enable us to move forward to commercialization.”
Anchora Chairman, Dr. Shimon Eckhouse, added: “Similar to sewing machines becoming a household item, Anchora Medical was founded in 2014 to extend these same ideas to bring automated and simplified suturing to minimally invasive surgery. We are delighted the Su2ura® has received FDA clearance to turn this vision into a reality.”