Regenesis Biomedical (Scottsdale. AZ) has received FDA approval for the Provant Therapy System to be used by patients with metallic implants after the US regulatory body reviewed additional scientific data on the topic. The FDA had previously approved the Provant for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue, but had listed the use of the system by patients with metallic implants as a contraindication.
The Provant Therapy System is a non-invasive device that creates an electromagnetic field to reduce pain, swelling, and edema after surgery by controlling inflammation and creating endogenous opioids. The Provant system may be used as an alternative or as an addition to prescribing opioids for pain reduction following a surgical procedure, potentially helping to reduce the healthcare risks associated with opioids.
The device, which needs to be prescribed by a physician, is shipped directly to the patient’s home by Regenesis. To receive treatment, the patient places the applicator directly over the region that is healing from surgery. The dome shaped electromagnetic field reportedly produces no sensation to the patient and creates no discomfort during treatment.
It is recommended that the patient use the device at one surgical location twice a day, at least 8 hours apart, for 30 minutes. It is also recommended to change the applicator covers, which are shipped with the device, after every treatment session. The device is capable of automatically adjusting the dose of the energy pulse based on each patient’s tissue characteristics.
With the FDA removal of the metallic implant contraindication, this pain management therapy may greatly help patients recovering from invasive orthopedic procedures such as total hip replacement surgeries.
Product page: PROVANT THERAPY SYSTEM…
Press release: FDA Clears the Provant Therapy System for Use by Patients with Metallic Implants…