The first six LOQTEQ Systems, manufactured by aap implantate AG in Germany, have received 510(k) clearance from the U.S. Food and Drug Administration (FDA). LOQTEQ is an anatomic orthopedic trauma plating system that, according to company officials, enables locking and compression with a single hole, enhancing ease of use for surgeons and improved operating room efficiency.
Innovative Trauma System Cleared by FDA
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Biense Visser, chief executive officer of aap Implantate AG, said, “With the first series of LOQTEQ products cleared in the U.S., we are positioned to execute our commercial strategy for this significant market for our trauma business. LOQTEQ has been well-received by the medical community in Europe, and we anticipate similarly strong adoption in the U.S. as the system is made available.”
The cleared LOQTEQ products address orthopedic trauma injuries for small and large bone fragments, arms (proximal humerus), and legs (distal femur, proximal lateral and distal medial tibia), providing surgeons withstate-of-the-art anatomical plates for a variety of musculoskeletal regions. The system features a threaded screw head design to enable single-step compression, angular stability and defined, adjustable compression from 0 mm to 2 mm, with automatic safe locking after full compression.
The company plans to launch six additional LOQTEQ systems in 2013. Jörg Schmidt, M.D., dhief of the Department of Orthopaedics, Trauma, Hand and Reconstructive Surgery at Asklepios Klinik Weissenfels in Weissenfels, Germany, said, “The LOQTEQ Compression Technology offers a great benefit especially in elderly patients with osteoporotic bones. The possibility of a secure fixation and compression is a huge gain in the compression osteosyntheses.”
Gerrit Oedekoven, M.D., chief of Trauma & Orthopaedics at St. Elisabeth Hospital, a teaching hospital of the Technical University Munich, in Straubing, Germany, said, “The LOQTEQ system is a combination of technological advanced anatomical plates and familiar AO operation techniques. The plates fit perfectly each time. The instrumentation is easy to understand and very functional.”
The system is currently marketed internationally in the CE region. The company plans a worldwide launch of an additional six LOQTEQ systems in 2013. Company officials expect the completion of the CE-conformity assessment procedures to take place in the first quarter of 2013 with the FDA-clearance coming later in the third quarter of 2013.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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