FDA Clears Medacta’s Midline Cortical Pedicle Screw Placement Guide

Medacta International, the family-owned global leader in innovative joint replacement and spinal technologies, announced clearance from the U.S. Food and Drug Administration (FDA) and the addition of MySpine Midline Cortical Pedicle Screw Placement Guide (MySpine MC) to its MySpine portfolio. The first two stateside surgeries utilizing MySpine MC were conducted this month, first by Nima Salari, M.D., of Scottsdale Shea Medical Center in Scottsdale, Ariz., followed by Jeffrey Henn, M.D., of Lee Memorial Hospital in Fort Myers, Fla.
 
MySpine MC enables surgeons to optimize procedures for both outpatient and inpatient settings and foster more rapid patient recovery through an accurate and reliable muscle-sparing approach to posterior lumbar surgery. This new technology guides the screw to a trajectory in the pedicle that evolved from the well-established cortical bone trajectory (CBT). Through accurate CT-based preoperative planning of a more caudomedial entry point than traditional pedicle screw trajectories and a less extreme caudal-cranial angle than CBT, the MySpine MC technique avoids interference with the cranial facet joints and accommodates larger screw diameters and lengths, with four points of cortical bone purchase for enhanced biomechanical fixation.
 
Achieving this improved screw trajectory through a small midline incision with a patient-matched guide can bring speed and reliability to the operating room, while potentially accelerating patient recovery and decreasing the risk of pedicle fractures, facet joint violation and nerve root injury. The intraoperative utilization of 3D-printed guides for pedicle screw placement facilitates accurate replication of pre-surgical planning to achieve the fine-tuned screw trajectory and may further reduce radiation exposure, muscular dissection and operative time.
 
Dr. Salari’s patient, the first to undergo surgery with MySpine MC, had dynamic spondylolisthesis at the L4/L5 level with severe spinal stenosis and neurogenic claudication, complicated by a history of diabetes and cardiovascular disease. “Given my patient’s condition and history,” Dr. Salari said, “I needed a minimally invasive option that would allow for a wide central decompression reinforced by excellent stabilization. We also needed to minimize anesthesia time for the patient, so it needed to be quick. The ability to pre-plan the surgery and work with a product that had been fully customized for the patient proved incredibly valuable. The surgery was fast, the screw placement was accurate, and the fixation was reliable. To top it off, we were able to reduce the need for intra-operative fluoroscopy, limiting the patient’s radiation exposure.”
 
Dr. Henn’s patient, who had severe stenosis and spondylolisthesis, is an athlete who was looking for the least invasive surgical solution. His goal was a relatively rapid return to his training and racing. Regarding the surgery, Dr. Henn said: “My patient’s pathology required decompression and instrumented fusion, historically a significant surgery with a long recovery. Using Medacta’s MySpine technology, prior to the procedure I was able to perform detailed surgical planning based on his specific anatomy. The result was a highly successful surgery, which I was able to perform in minimal time through a small incision. The MySpine guides worked flawlessly and, as a result, the need for intraoperative radiation was minimized, which was better for the patient and for the surgical team. The patient did very well and within one day of surgery, was walking extensively and reported less pain than he had prior to surgery—clearly a benefit of using the MySpine MC minimally invasive technique. I was extremely pleased with the system, and my patient was even more so.”
 
First introduced in 2014, Medacta’s MySpine technology can be customized for each patient’s anatomy and surgeon’s preferences and has been associated with greater accuracy of pedicle screw positioning, compared to freehand and other techniques, as well as reduced radiation, operative time and hospital stay. MySpine MC expands upon those benefits by enabling a biomechanically superior screw trajectory achieved through a minimally invasive approach. Surgeons across Europe, Australia and Asia have utilized MySpine MC and this novel multi-cortical approach in more than 100 spinal surgeries to date. MySpine MC is also supported by the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute, providing continuous educational and developmental support to Medacta surgeons as they work towards discovering new technologies and supporting patients.
 
“Medacta is known for disrupting surgical techniques with technology-backed approaches that are both surgeon- and patient-friendly,” said Francesco Siccardi, Executive Vice President of Medacta International. “Minimally invasive cortical bone fixation makes sense for posterior lumbar surgeries, but the technology to optimize and support it was lacking for many years. MySpine MC provides the answer to that need for the benefit of patients and surgeons alike.”