aap Implantate AG Receives FDA 510(k) Clearance for LOQTEQ® Trauma Plating System
(Thomson Reuters ONE) -
aap Implantate AG /
aap Implantate AG Receives FDA 510(k) Clearance for LOQTEQ® Trauma Plating
System
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First six LOQTEQ® Systems Now Cleared in the U.S.; Company Focused on
Commercialization Strategy
aap Implantate AG, (XETRA: AAQ.DE), a global medical device company focused on
innovative trauma products and biomaterials for the orthopaedic market,
announced that the first six systems of the LOQTEQ® Trauma Plating family of
products has received 510(k) clearance from the U.S. Food & Drug Administration
(FDA), following clearance of the first LOQTEQ® product in August 2012. LOQTEQ®
is an anatomic orthopaedic trauma plating system that enables locking and
compression with a single hole, enhancing ease of use for surgeons and improving
operating room efficiency.
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 (ISIN DE0005066609)
- Prime Standard/Regulated Market - All German stock markets -
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.
For inquiries please contact:
aap Implantate AG, Marc Heydrich, Investor Relations, Lorenzweg 5, 12099 Berlin,
Germany
Tel.: +49 30 7501 9-134, fax: +49 30 7501 9-290, m.heydrich(at)aap.de
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: aap Implantate AG via Thomson Reuters ONE
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Datum: 10.12.2012 - 11:15 Uhr
Sprache: Deutsch
News-ID 210953
Anzahl Zeichen: 6819
contact information:
Town:
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Kategorie:
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