Medicrea​ ​Receives​ ​FDA​ ​Clearance​ ​for​ ​3D-Printed​ ​Titanium​ ​Interbody​ ​Devices​

The Medicrea ® Group, pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ Adaptive Spine Intelligence™ (ASI) technology, announced today the Company has received Food and Drug Administration (FDA) clearance for its IB3D™ range of 3D-printed Titanium interbody devices and the introduction of AdapTEK™, its surgeon-adaptive technology.
a year ago

Lyon and New York, November 22, 2017

The Medicrea ® Group, pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ Adaptive Spine Intelligence™ (ASI) technology, announced today the Company has received Food and Drug Administration (FDA) clearance for its IB3D™ range of 3D-printed Titanium interbody devices and the introduction of AdapTEK™, its surgeon-adaptive technology.

AdapTEK™ allows a surgeon to create a range of interbody devices to their individual specifications that are then produced by Medicrea with complete in-house additive manufacturing capabilities and total control of the internal process without any of the limitations associated with subcontracting external suppliers. The technology leverages a surgeon’s clinical insight to design implants with a range of different footprints, lordotic angles, heights, lateral windows and endplate surface structure, including the proprietary HexaLOCK™ structure designed to enhance bone-implant interaction during the fusion process.

Photo: 3D-Printed​ ​Titanium​ ​Interbody​ ​Devices (credit: Medicrea®)

Denys Sournac, President and Chief Executive Officer, stated, “With the FDA clearance of our 3D-printed Titanium interbodies, we are able to approach a large segment of the spine market, where we were not previously present, with an adaptive range of implants delivered according to the clinical preferences and practices of individual spine surgeons. Our AdapTEK™ technology draws on the Company’s core competency to develop full-service solutions for spine surgery and aligns with the cage planning function of our proprietary UNiD™ HUB surgery planning software. This initial FDA clearance will support future strategic IB3D™ FDA clearances, which we will use to enhance our patient-specific UNiD™ ASI platform with the view of combining advanced cage planning capabilities with additive manufacturing to generate personalized interbody devices based on scientific data and precise MRI measurements at each level to select the right implant from thousands of available options.”

Medicrea’s scientific expertise is now complemented by its knowledge of the additive manufacturing process with the most technical aspects, notably the product master file, fully controlled and managed by the company's engineers, unlike competitors in the field. This key differentiation allows the Company to respond quickly and effectively to surgeons while closely controlling inventory levels. AdapTEK™ demonstrates Medicrea's ability to distinguish itself from traditional implant providers by providing a broad range of data-driven solutions and services generated by Adaptive Spine Intelligence™ to improve the outcomes and efficiencies in spine surgery.

Source: Medicrea

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