Exactech, a company specializing in the development and production of innovative implants, instrumentation, and smart technologies for joint replacement surgery, has announced the 510(k) clearance for its Activit-E™ polyethylene for the Vantage® Total Ankle System. This announcement follows the recent clearance of Activit-E for the Truliant® Knee System, which was revealed last month.

Activit-E is a next-generation highly crosslinked polyethylene with vitamin E antioxidant stabilization. It offers improved wear performance and higher fracture toughness compared to other highly crosslinked vitamin E polyethylenes. This is particularly significant when designing implants for an active patient population.

The unique manufacturing process of Activit-E involves peroxide crosslinking and the addition of vitamin E, which provides the material with strength, flexibility, toughness, and oxidative stability. This technology ensures that patients can benefit from highly crosslinked polyethylene even in situations where there is an anticipated shortage of gamma radiation for crosslinking.

Matt Hamilton, Director of Engineering, Foot and Ankle at Exactech, expressed excitement about incorporating Activit-E into their ankle portfolio, stating, "This advanced material gives us the best-wear performance we've tested combined with higher fracture toughness than other highly crosslinked vitamin E polyethylenes. Both are important factors when designing implants for a very active patient population."

Devan Carter, Foot and Ankle Marketing Director at Exactech, highlighted the optimized balance of material strength and toughness offered by Activit-E, emphasizing its potential to help patients return to their desired activities. Carter said, "We look forward to seeing how Activit-E, coupled with our data-driven total ankle system, can help patients nationwide get back to the activities they love."

Activit-E was developed by a team led by Dr. Orhun Muratoglu, the director of the Harris Orthopaedic Laboratory at Massachusetts General Hospital in Boston, and Dr. Ebru Oral, director of Biomaterials Research. This team invented the first-generation highly crosslinked polyethylene and pioneered Vitamin E stabilization in highly crosslinked polyethylenes used in clinical practice worldwide.

A pilot launch for Activit-E is anticipated in the first quarter of 2024, and attendees at the American Orthopaedic Foot and Ankle Society (AOFAS) Annual Meeting can get an exclusive look at this new technology at Exactech's booth (#301).

 

Source: businesswire.com

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