Lyon, France & New York – The Medicrea Group, worldwide leader pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, has received two unique 510(k) clearances from the U.S. Food and Drug Administration (FDA) for its PASSXS posterior fixation and LigaPASSXS 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 LPand 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.
About Medicrea
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.
Source: Medicrea