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FDA clears Tornier’s Simpliciti shoulder repair device

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FDA clears Tornier's Simpliciti shoulder repair device

Tornier (NSDQ:TRNX) today said the FDA cleared its new Simpliciti shoulder repair device for patients whose osteoarthritis or traumatic arthritis resulted in severely painful and/or disabled shoulder joints.

Amsterdam-based Tornier, which is gearing up for a $3.3 billion merger-of-equals with Wright Medical (NSDQ:WMGI), said the safety watchdog based its 510(k) clearance on a 3-year investigational device exemption trial of the Simpliciti device.

"In my practice, a new category of younger, more active patients has emerged. These patients are more demanding and aren’t satisfied with modifying their lifestyle as a result of shoulder pain. The humeral canal-sparing design and revision optionality of the Simpliciti shoulder system allows me to address this patient population that I have been hesitant to treat with traditional implant systems," lead investigator Dr. Sean Churchill said in prepared remarks. "Another benefit of the ultra-short stem design is the absence of a metal implant extending into the distal humeral canal, thereby reducing the risk of a mid-shaft humerus fracture, which can serve to compromise typical total shoulder implants."

"We are very pleased with the results of the Simpliciti clinical study which supported the FDA’s swift clearance of this innovative product. Studies, such as the Simpliciti IDE, serve as a testament to Tornier’s ongoing commitment to responsible science and technological evolution that provides extremity surgeons and their patients with unique solutions to address the debilitating results of osteoarthritis," added Tornier president & CEO Dave Mowry. "Similar to our market-leading Aequalis Ascend Flex shoulder system, we plan to introduce the Simpliciti product through a measured process to ensure education and training paces our product deployment. We believe building long-term success in this new category will take an investment in training and education while allowing the market time to develop."

The Tornier-Wright merger is awaiting the approval of U.S. anti-trust regulators, who last month extended their review of the deal with a formal request for more information.

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