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Home » FDA clears Medtronic patient-specific spinal rods

FDA clears Medtronic patient-specific spinal rods

June 3, 2021 By Danielle Kirsh

Medtronic logo updatedMedtronic (NYSE:MDT) today announced its UNiD patient-specific rods for its spinal systems won FDA clearance.

The UNiD rods are made for use with the medtech giant’s CD Horizon Solera Voyager and Infinity OCT spinal systems, which can be used with the Mazor robotic system.

Medtronic designed the rods to be industrially pre-bent before surgery to accurately match an artificial intelligence-driven, pre-operative surgical plan created by the UNiD adaptive spine intelligence (ASI) technology. The rods and ASI technology work to precisely align patients’ spines to reduce the risk of malalignment and associated revision surgeries, according to the company.

“Being able to integrate powerful complementary technologies — AI, robotics and patient-specific implants — is the future of spine surgery and will change spine care for the better by streamlining my workflow and reducing surgical uncertainty,” said Dr. Gregory Poulter, who performed the first surgery in the U.S. using the patient-specific rods.

“I’m not bending rods or increasing OR time with manual execution. Instead, I planned my first case with AI, selected the best hardware for my patient, executed the surgery with Mazor robotic-assisted delivery of the screws and was able to position the rod in 2.5 minutes, resulting in less blood loss and OR time and, most importantly, a predictable and precise alignment for my patient,” Poulter, who is based at OrthoIndy Hospital in Indianapolis, said in a news release.

UNiD ASI offers a planning service powered by AI for physicians to improve clinical outcomes. Surgeons can easily access the technology through a user-friendly UNiD HUB platform. It uses a database of thousands of surgical cases to power algorithms to visualize multiple permutations. AI helps surgeons visualize mechanisms above and below the spine that could occur based on the surgical plan.

“By combining our widely used spinal systems with UNiD rods, Medtronic is putting surgeons on the forefront and revolutionizing spine care as the first company to offer a fully integrated solution with unparalleled technologies — AI-driven surgical planning, personalized spinal implants and robotic-assisted surgical delivery that work together to advance patient care,” said Dan Wolf, VP of Medicrea within the neuroscience portfolio at Medtronic. “The next era of spine care is in personalized care that integrates the most advanced technologies to offer optimal planning, precision and predictability, so surgeons can do more for their patients.”

Filed Under: 510(k), Food & Drug Administration (FDA), Orthopedics, Regulatory/Compliance, Spine, Surgical Robotics Tagged With: Medtronic

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About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

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