Smith & Nephew Wednesday announced the U.S. launch of its Polarstem cementless stem for total hip replacement in the U.S.
The Class II device received FDA 510(k) clearance in October for the treatment of advanced degeneration of the hip joint from degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, failure of previous hip surgery, osteoarthritis, patients at risk of hip dislocation and femoral neck fracture or proximal fracture to the hip joint.
According to the British devicemaker, Polarstem’s design features make it optimal for muscle-sparing approaches by surgeons performing direct anterior approaches to total hip replacement. The proximal portion of the stem is wider, reducing the likelihood of movement too far down into the bone, while the distal portion is shorter with a narrower tip, making it easier to implant via a smaller incision, Smith & Nephew said. The stem’s advanced surface texture contains titanium plasma and a layer of hydroxyapatite.
The company’s VERILAST technology, which combines Oxinium-oxidized zirconium for the femoral head with a cross-linked polyethylene cup liner for the acetabulum, showed 67 percent less wear than cobalt chrome and XLPE in lab testing. Based on mid-term follow-up data, Polarstem’s survivorship was 99.5 percent at 5.6 years.
“When you add the wear-reducing advantages of our proprietary VERILAST technology, the final construct truly becomes an optimal hip replacement option,” said Gaurav Agarwal, president of orthopaedic reconstruction for Smith & Nephew’s Advanced Surgical Devices Division.
Polarstem is already available in the EU and Australia. — Lena Freund
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