Following a pilot clinical trial that demonstrated positive results for ApiFix’s minimally invasive adolescent idiopathic scoliosis correction system, the company has announced that the system has been awarded the CE mark.
According to a company press release, the correction system minimises risk, pain and scarring for the patients with adolescent idiopathic scoliosis and also speeds recovery. The system, the press release reported, is also associated with shorter, simpler procedure and costs less.
In the ApiFix system, a small implant is attached to the centre of the main spinal curvature using only two screws, resulting a 10cm scar—compared with an over 40cm scar in the standard procedure. After recovering from surgery, which takes only about an hour, the patient undergoes physical therapy treatments, during which the implant is gradually “educating” the spine into a correct position and “remembers” and reinforces each correction made.
The press release stated that prior to the CE mark, ApiFix successfully completed a pilot clinical trial in Europe, during which implants were executed in patients suffering from adolescent idiopathic scoliosis. “The results demonstrate the implant’s safety and success in correcting the curvature,” noted Uri Arnin, chief executive officer, ApiFix. “Within about three months, we achieved an impressive result, while maintaining spinal flexibility.”
From the outset, the company has worked in partnership with Yizhar Floman, a spinal surgeon at Assuta Hospital, Israel. During 2013, ApiFix will begin marketing the product to hospitals in Europe.
Eran Feldhay, Corporate VP, Life Sciences, The Trendlines Group said: “ApiFix has developed an effective, yet simple treatment that provides a revolutionary alternative to complex spinal surgeries that are currently standard practice. The company has sparked a great deal of interest and provides a solution for tens of thousands of young people around the world who suffer from adolescent idiopathic scoliosis.”