The Medicrea Group, worldwide leader pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, today announced that it has received two unique 510(k) clearances from the U.S. Food and Drug Administration.
The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), worldwide leader pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, today announced that it has received two unique 510(k) clearances from the U.S. Food and Drug Administration (FDA) for its PASS® XS posterior fixation and LigaPASS® XS band connector components designed to address pediatric spinal deformities in small stature patients.
The Company has worked with a team of leading pediatric spinal surgeons
to develop low-profile implants specially tailored for the unique
demands of pediatric deformity surgery. The extra-small ‘XS’ extension
of the PASS® and LigaPASS® technology will enable
surgeons to now effectively treat pediatric patients using around 40%
less implant volume in each surgery and the lowest construct profile
in-situ available on the market, while still offering the same technical
innovations of the PASS LP® and LigaPASS® systems
used on adults and UNiD™ Lab patient-specific, digital surgical planning
and analytical services.
“By adapting our industry-leading PASS® and LigaPASS®
deformity systems for the unique requirements of pediatric deformity
through the ‘XS’ components, Medicrea is continuing to strengthen its
position as a leader in FDA-cleared personalized analytical services and
implant solutions for the treatment of complex spinal conditions,”
stated Denys Sournac, President and CEO.
Medicrea is anticipated to announce the first U.S. surgery with the PASS
XS and LigaPASS XS components in early November.
Medicrea will showcase the advanced corrective capabilities of the
systems and attached personalized UNiD™ services at its booth (#943)
during the world’s largest scientific meeting for spine specialists,
held later this month, organized by the North American Spine Society
(NASS) in Boston from the 26th to the 29th of
October. During this event, the Company is also expected to announce a
major development related to the UNiD™ services and personalized
A Solution Showcase will be held during the meeting in the NASS Theater
on Thursday, October 27, at 12:30pm. The symposium will feature Dr.
Andrew King of New Orleans, LA, and Dr. Themistocles Protopsaltis of New
York, NY. Dr. King will present on Medicrea’s complex spine solutions
for pediatric patients and early results showing improved alignment and
patient outcomes using patient-specific UNiD™ technology. Dr.
Protopsaltis will present on the Company’s complex spine solutions for
cervico-thoracic indications and discuss the early results showing
improved alignment and patient outcomes using patient-specific UNiD™
Cervical Rod technology, of which the Company announced FDA clearance in
The Company has also previously announced that it is expecting the
significant 1,000th UNiD™ surgery milestone within the next
About Medicrea (www.medicrea.com)
Medicrea specializes in the design, manufacture, and distribution of
innovative proprietary technologies devoted exclusively to spinal
surgery. Operating in a $10 billion market, Medicrea operates with 150
employees, including 50 at its Medicrea USA Corp. subsidiary based in
New York City.
Medicrea is the only company to offer personalized value-based
healthcare solutions to the global complex spine market. The Company has
driven innovation in Spine by focusing development on market-disrupting
technologies focused on patient outcomes, including the growing UNiD™
Technology Platform of Patient-Specific Implants and Analytical
Services, which received the first-ever FDA clearance in November 2014
for a personalized spinal treatment modality.
Medicrea has uniquely positioned itself outside of the traditional
implant manufacturer’s role in order to engage with each market player
as a collaborator, offering customized implants to patients,
personalized services to doctors and immediate cost-savings to
providers. By leveraging its proprietary software analysis tools with
big data technologies, Medicrea is well-placed to improve the efficacy
of spinal care efficiency for all stakeholders in this market.