Hogan Lovells guides Integrum AB in FDA approval of prosthetic for above-the-knee amputations
Washington D.C., 18 December 2020 – Global law firm Hogan Lovells provided regulatory and scientific guidance to Swedish medical device company Integrum AB in order to obtain U.S. Food and Drug Administration approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.
The OPRA Implant System is the first implant system marketed in the U.S. for adults who have above-the-knee (transfemoral) amputations and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis.
Some patients, which often include wounded veterans and those with cancer, are unable to use a conventional socket prosthesis because they may not have a long enough residual limb to properly fit, or other prohibitive conditions such as scarring, pain, or skin infections. The OPRA Implant System is instead surgically anchored and integrated into the patient’s remaining thigh bone to allow connection to an external prosthetic limb.
The medical device, which was originally granted approval from FDA under a humanitarian device exemption, has now been moved forward through FDA’s Premarket Approval (PMA) pathway, its most strict device marketing application.
The Hogan Lovells regulatory team was led by partner Jonathan Kahan and included Senior Director Susan Tiedy-Stevenson and Senior Regulatory Affairs Specialist Megana Sankaran.
You can read the FDA press release here.