Conformis CFMS has received 510(k) clearance from the U.S. Food and Drug Administration for its Actera Hip System.
Actera utilizes an advanced tri-taper femur stem design that facilitates direct anterior approach total hip arthroplasties, and provides an additional stem option to orthopedic surgeons.
The tri-taper design objective is to facilitate a minimally invasive approach similar to direct anterior, with easier access to the femur and consequently less injury to muscles and fewer potential interactions with nerves.
Mark Augusti, Chief Executive Officer and President, stated, “We’re excited to expand Conformis’ hip portfolio with the addition of Actera, to satisfy the rise in surgeon demand for tri-taper stems. Surgeons have demonstrated a significant and growing preference for anterior total hip arthroplasty (THA) surgeries in recent years, and the innovative tri-taper stem is designed for easier placement. Peer-reviewed studies provide an increasing body of evidence that a tri-taper stem supports improved proximal load transfer and lower likelihood of implant loosening.”
Dr. Robert T. Trousdale, Board-certified orthopedic surgeon at the Mayo Clinic in Rochester, commented : “The Actera hip, with its tri-tapered stem, is the natural evolution of the Conformis personalized portfolio. It is well-suited to whichever surgical approach is chosen by the surgeon.”
The company will introduce the Actera hip system under a limited market release in select markets, which is expected to commence in the coming months.
Price Action : Conformis shares are trading around 16 percent higher at $0.31 on Tuesday during after-hours session.
Image and article originally from www.benzinga.com. Read the original article here.