FDA approves Medicrea’s patient-specific UNiD cervical rod

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The US Food and Drug Adminstration (FDA) has approved the UNiD cervical rod for spinal surgery, when secured by their PASS OCT posterior cervical stabilisation system.

Immediately following the FDA clearance, Medicrea expanded their personalised UNiD technology and services to the cervical spine with the first implantation of the UNiD patient-specific cervical rod in New York City, USA.

With this addition, the company announced that UNiD lab personalised spinal alignment services are now available to cover the entire cervical, thoracic and lumbar regions. The UNiD rod is custom-designed for operations in these regions, to scientifically match the rod’s shape with each patient’s unique spinal alignment and the surgeon’s preoperative plan.

Following surgical intervention in the occipito-cervical spine, the shape of the rod directly impacts the fixed position of the head and neck, dramatically changing how the patient looks.

The UNiD cervical rod technology is designed to remove existing surgical barriers by creating two strictly identical single or dual-diameter rods manufactured specifically for the patient and delivered directly to the Operating Room.

 

Following the surgery, Protopsaltis stated, “This pre-contoured patient-specific implant has eliminated the difficulty of manually bending transition rods, saving operating room time and optimising the execution of my operative plan professional collaboration with Medicrea’s UNiD lab.”

UNiD patient-specific cervical rods are available in two alloys (titanium TA6V ELI/cobalt chromium) and in a single-diameter (3.5mm) or dual-diameter options (3.5mm transitioning to either 5.5mm or 6mm). The rods are secured using Medicrea’s PASS (Polyaxial spine system) OCT posterior cervical stabilisation system, which is designed to allow 11mm of gentle reduction capability across all anchorages and medial or lateral rod placement.