Medtronic has received FDA 510(k) clearance and breakthrough device designation for its LigaPass 2.0 ligament augmentation system.
LigaPass was developed by Medicrea, which Medtronic acquired in late 2020. It is the only device the FDA has cleared for ligament augmentation in spine surgery, the company said in a June 17 news release.
Ligament augmentation has been studied for its effect on proximal junctional kyphosis, a common complication after adult spinal deformity surgery, according to Medtronic. Patients with the condition could develop structural and neurological complications, which increases the need for revision surgery.
"Failure reduction strategies, such as ligament augmentation, are likely to become critical techniques in the treatment of this challenging patient population," said Christopher Ames, MD, director of spinal tumor and spinal deformity surgery at UCSF Medical Center in San Francisco. "LigaPass 2.0 helps me meet my goals to reduce revision surgeries with these patients."
The LigaPASS 2.0 system can be integrated with the UNiD Adaptive Spine Intelligence portfolio, which leverages artificial intelligence, predictive modeling and patient-specific implants in spine surgery, according to the release.