Medtronic’s LigaPASS 2.0 OK’ed for Ligament Augmentation in Spine Surgery

Medtronic has received U.S. Food and Drug Administration (FDA) clearance and breakthrough status for its LigaPASS 2.0 ligament augmentation system. According to Medtornic, LigaPASS is the first and only FDA-cleared device for ligament augmentation in spine surgery.
 
Proximal junctional kyphosis (PJK) is a frequent post-op complication of adult spinal deformity surgery that causes spinal ligament disruption. It can significantly impact quality of life and severity can vary—some patients develop a more severe form called proximal junctional failure (PJF) and may develop structural and neurological complications.
 
“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,” Christopher Ames, MD, director of spinal tumor and spinal deformity surgery at UCSF Medical Center told the press. “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.”
 
A 242-patient study of adult spinal deformity cases found those treated with ligament augmentation had “significantly lower” PJK and PJF rates. After a year, ligament augmentation patients’ rate of complications was 3.3% compared to 15.6% of those not treated with the technique.
 
LigaPASS 2.0 can be paired with UNiD adaptive spine intelligence to leverage data science and AI to help plan, execute, and analyze spine procedures. LigaPASS 2.0 connectors and bands can also be used in conjunction with Medtronic’s CD Horizon Solera spinal system.
 
“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, Medtronic’s VP and GM of Intelligent Data Solutions.