21.08.2019 07:29:02
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DGAP-News: aap receives US-American clearance (FDA) for polyaxial LOQTEQ(R) VA calcaneus system; market launch planned for beginning of 2020
DGAP-News: aap Implantate AG / Key word(s): Product Launch/Market launch aap Implantate AG ("aap") announces that its new LOQTEQ(R) VA calcaneus plates 3.5 have been cleared by the US-American Food and Drug Administration (FDA). The Company plans to launch the LOQTEQ(R) VA calcaneus system at the beginning of 2020 in the United States and in other markets that accept FDA clearances. The system enables flexible treatment of fractures of the heel bone, which is one of the important load-bearing joints of the lower extremity. The LOQTEQ(R) VA calcaneus plates 3.5 belong to the LOQTEQ(R) VA (VA = Variable Angle) product family. These are polyaxial implants that facilitate inserting angle-stable screws at different angles, thereby improving flexibility within the application.
With its new calcaneus system, aap addresses the foot and ankle segment, which with an average annual growth rate of around 9% is one of the fastest growing segments of the trauma market[1] and accounts for almost half of the total extremities market. The treatment of calcaneus or heel bone fractures is very often performed surgically, as these have a high joint involvement rate of 75%. To meet patients' growing demands, a swift and stable treatment is required that enables an early restoration of mobility. The anatomically preformed, angle-stable plates of the LOQTEQ(R) VA systems in conjunction with freely selectable screw angles, user-friendly instruments and a high stability fulfils all the requirements of modern surgery. The LOQTEQ(R) VA calcaneus system 3.5 contains different plates for the treatment of the heel bone in two different sizes and designs, whose low profile height of only 1.6 mm with a type II anodization contributes to the comfort of users and patients. In view of launching the calcaneus plates in the European market, aap is currently preparing the documents for the corresponding conformity assessment procedure for the CE label. With the LOQTEQ(R) VA calcaneus system 3.5 aap takes a further important step on the way to the completion of its portfolio, which will increase the attractiveness for full-service clinics and purchasing groups as well. ----------------------------------------------------------------
21.08.2019 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
Language: | English |
Company: | aap Implantate AG |
Lorenzweg 5 | |
12099 Berlin | |
Germany | |
Phone: | +49 (0) 30 75 01 90 |
Fax: | +49 (0) 30 75 01 91 11 |
E-mail: | info@aap.de |
Internet: | www.aap.de |
ISIN: | DE0005066609 |
WKN: | 506660 |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange |
EQS News ID: | 860567 |
End of News | DGAP News Service |
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860567 21.08.2019
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