Medtronic Obtains FDA Clearance for Patient-Specific UNiD Rods for Use with Horizon Solera Voyager and Infinity OCT Spinal CD Systems

Medtronic plc (NYSE: MDT), the world leader in medical technology, today announced US Food and Drug Administration (FDA) clearance for patient-specific UNiD ™ rods for use with Medtronic CD Horizon ™ Solera ™ Voyager ™ and Infinity ™ OCT spinal systems, expanding the utility of the company’s UNiD ™ Adaptive Spine Intelligence (ASI) technology. UNiD rods are designed for each patient and industrially pre-bent prior to surgery to precisely match an artificial intelligence (AI) -based preoperative surgical plan, which is created with UNiD ™ ASI technology to precisely align the spine spine of patients 1, 2, reduce the risk of misalignment and associated revision surgeries. 3 UNiD Rods are used to treat scoliosis, trauma, tumors and complex degenerative conditions in adults and adolescents with idiopathic scoliosis.

Spine surgery is one of the most complex procedures in health care due to the large number of different parameters that must be taken into consideration. In conventional spine surgery, surgeons manually bend the spinal rods in the operating room, and there can be great variability in the results. With the compatibility of UNiD rods and Medtronic spinal systems, surgeons are able to customize rods, as well as select Medtronic interbody devices and other materials best suited to unique anatomy and alignment needs. sagittal of their patient. Additionally, surgeons can use advanced navigation and robotics, such as the Mazor ™ robotic guidance system, with minimally invasive patient-specific rods to make procedures more precise and efficient and improve surgical outcomes.

The first surgery combining the Horizon Solera Voyager CD minimally invasive spinal system with patient-specific UNiD rods in combination with the Mazor platform was performed by Dr. Gregory Poulter , OrthoIndy Hospital, Indianapolis, Indiana.

“Being able to integrate powerful complementary technologies – AI, robotics, and patient-specific implants – is the future of spine surgery and will improve spine care by streamlining my workflow and reducing the burden on my spine. surgical uncertainty, ”said Dr. Poulter. “I don’t bend the rods or increase the operating time with manual execution. Instead, I planned my first case with AI, selected the best material for my patient, performed the surgery with Mazor robot-assisted delivery of the screws, and was able to position the rod in 2.5 minutes. , which resulted in less blood loss and operating time, and most importantly, predictable and precise alignment for my patient.

Spine surgery is evolving and becoming more and more personalized. It is no longer driven solely by metal implants and instruments, but by advanced AI-assisted imaging, navigation, robotics and preoperative planning. UNiD ™ Adaptive Spine Intelligence provides AI-powered planning service, intraoperative execution, and insightful analyzes of surgical outcomes with the ultimate goal of improving clinical outcomes. This revolutionary solution is easily accessible to any surgeon via a user-friendly UNiD ™ HUB platform.

“By combining our widely used spinal systems with UNiD rods, Medtronic is putting surgeons at the forefront and revolutionizing spine care as the first company to offer a fully integrated solution with unmatched technologies – surgical planning based on AI, personalized spinal implants and robot-assisted surgery delivery that work together to advance patient care, ”said Dan wolf , Vice President of Medicrea, within the Cranial & Spinal Technologies division, which is part of the Medtronic neuroscience portfolio. “The next era of spine care is one of personalized care that integrates the most advanced technologies to deliver optimal planning, precision and predictability, so surgeons can do more for their patients. ”

About the UNiD ™ ASI platform
The UNiD ASI platform uses a database of thousands of surgical cases to feed algorithms that visualize multiple permutations, allowing surgeons to better understand the alignment of their patients before surgery, to customize a surgical plan with biomedical engineers Highly skilled UNiD ™ LAB and use a patient-specific rod industrially bent into the optimal plane to help ensure that surgery goals are met. AI helps visualize the mechanisms above and below the spine that will most likely occur depending on the surgical plan to improve clinical and surgical workflow, increase reproducibility, and improve surgical results.

About the Horizon ™ Solera ™ Voyager ™ and Infinity ™ OCT CD Spine Systems
These systems help ensure the immobilization and stabilization of segments of the spine. The systems consist of a variety of screws and other implant components that can be rigidly locked in a variety of configurations, with each construction custom-designed for the patient’s unique anatomy and alignment needs. sagittal.

About Medtronic
Medtronic plc ( www.medtronic.com ), headquartered at Dublin, Ireland , is one of the world’s largest medical technology, services and solutions companies – relieving pain, restoring health and extending the lives of millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on working with stakeholders around the world to advance healthcare, together.

Any forward-looking statement is subject to risks and uncertainties such as those described in Medtronic’s periodic reports filed with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

¹ Cameron Barton BA, Andriy Noshchenko PhD, Vikas patel MARYLAND, Christophe Kleck MARYLAND, Burger Evalina MARYLAND. Early experience and initial results with patient-specific spine rods for adult spine deformity (ASD). Orthopedics. 2016; 39 (2): 79-86.
² Kuris, Eren et al. “Analysis of radiographic parameters reveals differences in results when comparing patient-specific short-stem constructions to conventional stems in lumbar fusions for degenerative diseases.” International Meeting on Advanced Spine Technologies. 2020.
³ Rothenfluh DA, Mueller DA, et al. The mismatch of pelvic lumbar lordosis incidence predisposes to adjacent segment disease after lumbar spinal fusion. Eur Spine J (2015) 24: 1251-1258

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SOURCE Medtronic plc