With any new technology, particularly in medicine, some anxiety comes along with the excitement. No matter how promising a new drug or procedure is, people – particularly those looking at taking the drug or undergoing the procedure – rightly feel some apprehension. Will it work as well as they say it’s going to work? What about side effects? Even with the stringent testing required for FDA approval, many people understandably want real-world proof of the effects of anything new in the medical world.
Back pain sufferers considering spinal implants can begin feeling a lot more confident about the patient-specific implants developed by MEDICREA. The company, which uses 3D printing to fabricate many of their medical implants, announced earlier this year that they had received FDA approval for the world’s first patient-specific cervical rod, UNiD. The device carried the promise of dramatic change in spinal alignment surgeries by replacing traditional one-size-fits-all rods with implants designed to perfectly aligned the the individual patient’s spine.
Previously, surgeons inserting spinal rods would have to manually bend them during surgery to approximate the alignment of the patient’s spine, a tricky process and one that often results in less-than-perfect alignment and painful complications. Research has shown that nearly 1 in 10 patients who have undergone spinal fusion surgeries with traditionally manufactured rods later experience symptomatic rod fracture, requiring additional surgeries.
In contrast, the UNiD spinal rods have shown themselves to be overwhelmingly successful thus far – so much so that MEDICREA is offering a lifetime warranty on the implants, the first company to do so.
“Because of the overwhelmingly positive results obtained in all of the 950 plus UNiD patient-specific cases performed to date and our confidence in the science behind UNi™ technology, MEDICREA is taking the extra step to warranty each patient-specific implanted construct for the duration of the patient’s life,” said Denys Sournac, MEDICREA President and CEO. “This is a true testament to our belief that, by offering surgical planning services with a patient-specific device, MEDICREA is eliminating the inherent risks and associated costs to the healthcare system that are created by manually bending a rod during surgery.
“While we know scientifically that sagittal alignment is linked to patient outcomes, our experience with UNiD has shown that applying the correct alignment to the rod, using proprietary digital analysis organization that we have developed, may also be directly linked to a reduction in surgical complications such as mechanical failures and revision rate – something that was previously only theorized.”
Not only can patients feel reassured by the “overwhelmingly positive results” of UNiD so far, they can also rest easy knowing that even in the unlikely case that their implants do fail, they can have them repaired at no cost. With the costs of surgeries to repair failed spinal implants currently totaling around $80,000, that’s not an insignificant concern.
The lifetime warranty is offered, according to MEDICREA, as an affiliated benefit of the UNiD Lab Premier Service, which includes real-time support from a team of biomechanical engineers supporting all pre-operative planning as well as post-operative analytical services. The warranty, which applies to all UNiD Thoracolumbar Rods, UNiD Cervical Rods and associated components and services, will be effective beginning November 1 in the United States, and will be extended to all countries using the technology.
MEDICREA’s announcement coincides with the start of the North American Spine Society (NASS) Annual Meeting, which runs from October 26 to 29 in Boston. MEDICREA will host a “Solution Showcase” on October 27 at 12:30 PM, where they will present the early results of their UNiD technology, as well as their other spinal solutions. The company is also in the process of launching a full 3D printing factory at their main location in Lyon, so we expect to see a lot more exciting technology coming from them in the near future. For more information about the UNiD process, read here. Discuss in the MEDICREA forum at 3DPB.com.