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Orthopedicians
can now recommend a new Implant System for
patients with transfemoral or
above-the-knee amputation.
The first-ever US marketed, prosthesis Implant System was recently approved by the FDA on 18th December 2020 for transfemoral or above-the-knee amputees and who have or are expected to have issues with rehabilitation, or cannot use the standard socket prosthesis.
FDA's director of the Center for Devices and Radiological Health's Office of Orthopedic Devices stated that, “The use of prostheses can be beneficial in individuals who have lost a leg because of trauma or malignancy to recuperate movement and resume their routine work with ease.”
The use of standard leg prosthesis is often associated with ill-fitted socket prosthesis or even scarring, repeated skin infections, pain, or variations in the shape of the residual limb thereby obstructing its usage as a prosthesis with a socket. But this invasive novel implant provides suitable fitting as it is anchored and joined into the patient's residual thigh bone to an external prosthetic limb.
Since 2015, this prosthesis Implant was placed under the humanitarian device exemption proposed to benefit patients in the management of a disease affecting not more than 8,000 people per year in the US. Hence, this approval has expanded its usage in the total patient population.
Using the Questionnaire for Persons with a Transfemoral Amputation, the FDA assessed the safety and efficacy in a clinical study of 65 individuals with this Implant System. It portrayed a good average improvement in the prosthetic use score on a 100-point scale for different years against the standard socket prosthesis as shown in the following table:
Mechanical
complications, infection, pain, injury and loosening of the fixture were some
of the reported adverse events. The patients should
discuss the advantages and risks of all prosthetic options with the concerning
physicians.
FDA
FDA Approves Prosthetic Implant for Above-the-Knee Amputations
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