August 2013

FDA clears Empi Phoenix stimulator

The Empi Phoenix, a neuromuscular electrical stimulator designed to supplement physical therapy before or after surgery for total knee replacement or anterior cruciate ligament repair, has received 510(k) clearance from the Food and Drug Administration, according to a July statement from manufacturer DJO Global, headquartered in Vista, CA.

The stimulator helps address disuse atrophy before and after surgery and offers treatments to manage pain and reduce swelling.

In a paper published in March in Orthopedics, investigators found the device produced equivalent results to conventional physical therapy with regard to strength and function measures.

Researchers randomized 70 patients after total knee arthroplasty to a postsurgical program of range of motion and strengthening exercise supervised by a therapist or to an unsupervised home program of similar exercises plus electrical stimulation.

Function and strength tests demonstrated noninferiority of the device plus home exercise program at six weeks and six months postoperatively.

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