EQS Group-Ad-hoc: Medacta Group SA / Key word(s): Regulatory Approval
Medacta Receives FDA Clearance for MyShoulder Placement Guides
17-Dec-2019 / 19:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 KR
The issuer is solely responsible for the content of this announcement.
*Press Release*
*Medacta Receives FDA Clearance for MyShoulder Placement Guides*
_CASTEL SAN PIETRO_, 17 December 2019 -Medacta announced today it has
received clearance from the U.S. Food and Drug Administration (FDA) for its
MyShoulder Placement Guides for shoulder arthroplasty, following approval
from the Japanese Ministry of Health, Labour and Welfare (MHLW) earlier this
year. These patient-matched, 3D-printed solutions work in conjunction with
the Medacta Shoulder System and associated instrumentation to help the
surgeon create an accurate and reproducible implant placement specific to
each patient's individual anatomy.
The MyShoulder system is the first patient-specific offering in the United
States to provide both humeral and glenoid guides, in order to facilitate
execution of the surgical plan. Detailed patient modeling, via computed
tomography (CT) imaging, supports precise reconstruction of patient bone
morphology for a patient-matched fit that helps surgeons improve accuracy
both in preoperative planning and surgery.
"Working with the MyShoulder Placement Guides enables me to play a key role
in the surgical process from start to finish. Access to pre-operative
planning and the support of a dedicated technician are key aspects of the
platform and ensure the resulting guides are optimized for each procedure
and patient," said Matthew D. Saltzman, M.D., Associate Professor of
Orthopaedic Surgery at the Northwestern Memorial Hospital in Chicago,
Illinois. "This level of collaboration associated with the system, alongside
Medacta's robust suite of implants and instruments, creates a thorough
solution that's easy to implement in the OR."
MyShoulder is in line with Medacta's broader focus on personalized surgical
approaches, an area of orthopedics the company has advanced through its
sophisticated "MySolutions" technology. In addition to MyShoulder,
MySolutions also includes Medacta's MyKnee, MyHip and MySpine platforms,
which have resulted in standard-of-care breakthroughs for joint replacement
and spine surgery.
"Medacta is dedicated to empowering surgeons through technology. Our goal is
to provide solutions that encourage surgeon input at all stages of the
surgical process while providing patient-specific designs and insights to
support them," said Francesco Siccardi, Chief Executive Officer of Medacta
International. "We've received incredibly positive feedback from surgeons
using our patient-matched solutions in joint and spine and are thrilled to
bring this level of precision and collaboration to U.S. surgeons practicing
shoulder arthroplasty as well."
The MyShoulder Placement Guides will also be added to the educational
offering of Medacta's Shoulder Learning Centers in the United States
organized by the prestigious M.O.R.E. Institute. For more information on
MyShoulder and Medacta's shoulder arthroplasty solutions, visit
www.medacta.com/EN/myshoulder [1].
*Contact*
Medacta Group SA
Corrado Farsetta, CFO
Phone: +41 91 696 60 60
investor.relations@medacta.ch
*About Medacta*
Medacta is an international company specializing in the design and
production of innovative orthopaedic products and the development of
accompanying surgical techniques for joint replacement, spine surgery, and
sports medicine. Established in 1999 in Switzerland, Medacta's products and
surgical techniques are characterized by innovation. Medacta is a pioneer in
developing new offerings on the basis of minimally invasive surgical
techniques, in particular its Anterior Minimally Invasive Surgery ('AMIS')
technique for hip replacements. Medacta has leveraged its orthopaedic
expertise and comprehensive understanding of the human body to develop the
sophisticated 'MySolutions' technology, which offers surgeons highly
personalized pre-operative planning and implant placement methodologies by
creating advanced personalized kinematic models and 3D planning tools for
use in hip, knee, shoulder and spine procedures.
End of ad hoc announcement
Language: English
Company: Medacta Group SA
Strada Regina
6874 Castel San Pietro
Switzerland
Phone: +41 91 696 6060
E-mail: info@medacta.ch, investor.relations@medacta.ch
Internet: www.medacta.com
ISIN: CH0468525222
Listed: SIX Swiss Exchange
EQS News ID: 938581
End of Announcement EQS Group News Service
938581 17-Dec-2019 CET/CEST
1: https://link.cockpit.eqs.com/cgi-bin/fncls.ssp?fn=redirect&url=d219cd026f20015fcdf0299e7b86d583&application_id=938581&site_id=vwd&application_name=news
(END) Dow Jones Newswires
December 17, 2019 13:00 ET (18:00 GMT)
