Medicrea Announces 510(k) Submission for FDA Clearance of Proprietary 3D Printed Titanium Spinal Interbody Devices
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 the filing of its 510(k) submission to the U.S. Food and Drug Administration (FDA) for approval of the Company’s 3D printed titanium interbody devices, with compatible UNiD™ Lab personalized surgical planning and analytical services.
Denys SOURNAC, President and CEO, stated, “As the first company in spine to develop the highly technical capabilities and differentiated infrastructure required to support a personalized approach to each individual spinal surgical procedure, Medicrea continues to further advance its leading position in the U.S. market, which is estimated at nearly $6 billion, for our UNiD™ patient-specific technologies. With in-house additive manufacturing capabilities and FDA clearance anticipated before the end of 2017, Medicrea’s platform of 3D printed Titanium devices will enable the Company to provide an even more robust and comprehensive solution for patients and surgeons.”
Rick KIENZLE, Chief Commercial Officer, added, “The associated UNiD™ Lab services enable the surgeon to pre-operatively define the exact 3D printed interbody anatomical specifications matched with a predictive analysis of global spinal alignment parameters, directly linked to clinical results.”
The Company’s deep expertise with digital surgical modeling, combined with the precise inventory control afforded by in-house 3D printing technology, enables Medicrea to personalize the implant selection and alignment requirements for each patient prior to surgery in order to achieve an iterative procedural cycle, thereby increasing surgical efficiency, streamlining inventory requirements and significantly reducing the high number of costly revision surgeries currently experienced in traditional spinal surgery.
Medicrea first introduced its comprehensive, service-based approach to personalized spine with UNiD™ Rod technology, the first patient-specific spinal implant to be FDA-cleared in late 2014, which recently surpassed 1,100 procedures at the end of 2016. With the development of 3D printed Titanium technology and compatible UNiD™ Lab services, Medicrea continues to transform the relationship between healthcare providers and device manufacturers in the spine industry by creating a collaborative interaction that results in reliable, data-driven personalized patient care.
Medicrea specializes in bringing pre-operative digital planning and pre- and post-operative analytical services to the world of complex spine. Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA-approved implant technologies, utilized in over 100k spinal surgeries to date. Operating in a $10 billion marketplace, Medicrea is an SME with 160 employees worldwide, which includes 55 at its USA Corp. subsidiary in NYC. The Company has an ultra-modern manufacturing facility in Lyon, France, housing the development and production of 3D printed Titanium patient-specific implants.
By leveraging its proprietary software analysis tools with big data and deep learning technologies supported by an expansive collection of clinical and scientific data, Medicrea is well placed to streamline the efficiency of spinal care, reducing procedural complications and limiting time spent in the O.R.