Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance and breakthrough device designation for its LigaPASS 2.0.
According to a news release, LigaPass is the first and only FDA-cleared device with an indication for ligament augmentation in spine surgery.
The company designed the LigaPASS 2.0 ligament augmentation system due to its positive impact on proximal junctional kyphosis (PJK), a common post-operative complication with adult spinal deformity surgery that can lead to the development of the more severe form, proximal junctional failure (PJF).
“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,” UCSF Medical Center director of spinal tumor and spinal deformity surgery Dr. Christopher Ames said in the release. “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.”
Medtronic said a study of 242 adult spinal deformity cases found that patients treated with ligament augmentation had significantly lower PJK and PJF complication rates. After one year, the reoperation rate for adult spinal deformity patients treated with ligament augmentation was just 3.3% compared to 15.6% in those not treated with ligament augmentation.
The LigaPASS 2.0 system can be paired with the UNiD adaptive spine intelligence (ASI) platform for leveraging data science and artificial intelligence (AI) to help surgeons plan, execute and analyze procedures. The system connectors and bands for the LigaPass 2.0 system can also be used in conjunction with the 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,” Medtronic VP and GM for Intelligent Data Solutions Dan Wolf said.