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Medtronic’s Ligament Augmentation Device Receives World-first FDA Approval

One of the global leaders in healthcare technology, Medtronic PLC, has recently received FDA (the US Food and Drug Administration) approval, as well as Breakthrough Device designation regarding its LigaPASS 2.0 tech. The latter is a Ligament Augmentation System, and it is the 1st and so far only FDA-cleared device with is designed for ligament augmentation within the field of spinal surgery.

Ligament augmentation has been the subject of study for use on PKJ proximal junctional kyphosis), which is a common post-op complication of spinal deformity surgery in adults. Though the precise cause in unknown, PJK is assumed to involve the disruption of of spinal ligaments, and can likely affect up to 46% of all patients. It is a condition which can significantly impact the patient’s quality of life, and while its severity can differ from subject to subject, there is a risk that it can mutate into a more severe form, know as PJF (proximal junctional failure). Patients who develop this may end up suffering from neurological and structural complications, leading to the need for further surgery.

“The surgical treatment of adult spinal deformity provides significant clinical benefit to patients but unfortunately many require revision due to early mechanical failure. The most common cause of mechanical failure is proximal junctional kyphosis,” said Christopher Ames, M.D., Director of Spinal Tumor and Spinal DeformitySurgery at UCSF Medical Center in California. “Failure reduction strategies, such as ligament augmentation, are likely to become critical techniques in the treatment of this challenging patient population. In my practice, LigaPASS™ 2.0 helps me meet my goals to reduce revision surgeries with these patients.”

It is also possible to pair the LigaPASS 2.0 system with the UNID ASI (Adaptive Spine Intelligence) platform. UNID’s ASI is improving the standard of care of patient specific spinal surgery by utilising data science and AI aid surgeons in the planning, analysis and execution of their procedures.

“This clearance and Breakthrough Device designation demonstrates our ongoing commitment to innovation in spine surgery and delivering industry-leading solutions that improve care for patients and improve the experience for surgeons,” said Dan Wolf, Vice President and General Manager, Intelligent Data Solutions at Medtronic.

The ligament augmentation technique made possible by LigaPASS offers surgeons the possibility of stabilising between collapsed vertebrae in adult patients with spinal deformities who require constructs which may extend as far as the pelvis. This new procedure is built with the aim of compensating for muscle collapse during open posterior surgery, as well as aiming to decrease junctional stress.



© Medtronic PLC

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