- Pressemitteilung BoxID 373058
aap Implantate AG Receives FDA 510(k) Clearance for LOQTEQ® Trauma Plating System
First six LOQTEQ® Systems Now Cleared in the U.S. / Company Focused on Commercialization Strategy
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. Given our high confidence in the surgeon and patient benefits of the technology, we are continuing to invest in the product family, with the expected launch of additional six LOQTEQ® systems that will round out the portfolio planned for 2013."
The cleared LOQTEQ® products include six plating systems to address orthopaedic trauma injuries for small and large bone fragments, arms (proximal humerus), and legs (distal femur, proximal lateral and distal medial tibia), providing surgeons with state-of-the-art anatomical plates for a variety of muskuloskeletal regions. The system features a unique threaded screw head design to enable single-step compression and angular stability. It offers defined, adjustable compression from 0 mm to 2 mm, with automatic safe locking after full compression. The first six LOQTEQ® systems are expected to be commercially available in the U.S. in early 2013.
Jörg Schmidt, MD, Chief 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. LOQTEQ® has a perfect anatomical fit to nearly every bone."
Prof. Dr. Gerrit Oedekoven, MD, 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 LOQTEQ® system, manufactured in Germany, is currently marketed internationally in the CE region. Worldwide launch of an additional six LOQTEQ® systems is planned for 2013. For these additional six systems, the completion of the CE-conformity assessment procedures is expected for the first quarter of 2013 and the FDA-clearance latest in the third quarter of 2013. For more information about aap and its trauma portfolio, please visit www.aap.de.
This release contains forward-looking statements based on current experience, estimates and projections of the management board and currently available information. They are not guarantees of future performance. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. Many factors could cause the actual results, performance or achievements of aap to be materially different from those that may be expressed or implied by such statements. These factors include those discussed in aap's public reports. Forward-looking statements therefore speak only as of the date they are made. aap does not assume any obligation to update the forward-looking statements contained in this release or to conform them to future events or developments.
aap Implantate AG
aap is a global medical device company headquartered in Berlin, Germany that develops, manufactures and markets innovative biomaterials and implants that are used in orthopedic procedures. The Company's products, which include a full line of plating systems, cannulated screws and bone cement products, are primarily used in the orthopedic specialty areas of trauma and spine repair. The Company's products are sold through its direct sales force, distribution partners and license agreements with OEM partners. aap's stock is listed in the Prime Standard segment of the Frankfurt Stock Exchange. For more information, please visit www.aap.de, or download the Company's investor relations app from the Apple's App Store or Google Play.
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