Wright Medical (NSDQ:WMGI) snagged the FDA’s 510(k) clearance to start marketing a new external fixation device designed to position foot and ankle bones during surgery.
The Tennessee medical device company’s latest regulatory win is for its Salvation external fixation system, a metal exoskeleton made of tensioned thin wires, half pins and metal rings that helps position the foot and lower leg during surgery.
The device is designed to be used on its own or with other Salvation limb salvage products to treat fractures, non-connected bones and also foot/ankle deformities. The whole Salvation product line is indicated to treat a condition known as neuropathic osteoarthropathy or Charcot foot, a deformity involving collapse of the foot stemming from foot or ankle-related nerve damage.
Wright said it plans to begin "limited physician testing" of the device during the 2nd quarter.
President & CEO Robert Palmisano said Wright has "a unique future opportunity to address advanced reconstructive, limb salvage, and Charcot cases with our Salvation product portfolio. Despite the large and growing population at high-risk of peripheral neuropathies, the Charcot market remains underserved in terms of a comprehensive solution. We are looking forward to collecting initial physician testing and market assessment data for our Salvation product portfolio in preparation for a future product launch."
Wright is gearing up for a $3.3 billion “merger of equals" with Tornier (NSDQ:TRNX), as U.S. anti-trust regulators review the deal. Wright announced plans in February to float $400 million worth of senior notes to help cover the cash portion of the buyout.