FDA Clears First Spine Device for Ligament Augmentation

Medtronic plc, has received U.S. FDA 510(k) clearance and Breakthrough Device designation for its novel LigaPASS™ 2.0 Ligament Augmentation System. LigaPASS™ is the first and only FDA cleared device with indication for ligament augmentation in spine surgery.

Background

Proximal junctional kyphosis (PJK) is a frequent post-operative complication of adult spinal deformity surgery. While the exact cause is unknown, PJK is thought to involve disruption of spinal ligaments. It and can reportedly affect up to 46% of patients and can significantly impact a patient’s quality of life. The severity of PJK can vary, and some patients may develop a more severe form of the condition called proximal junctional failure (PJF). Patients who develop PJF may develop structural and neurological complications, which increases the need for revision surgery.

Medtronic’s LigaPASS™ ligament augmentation technique provides surgeons the ability to stabilize between vertebrae that are collapsed or are at risk of collapsing in adult spinal deformity patients requiring constructs that may extend from T1 to the pelvis. This innovative surgical procedure aims to compensate for muscle collapse during open posterior surgery and decrease junctional stress at the UIV and adjacent levels through a band lacing technique using LigaPASS™ 2.0 system implants. The LigaPASS™ 2.0 system medial connector is designed to provide additional support to the junction between the instrumented and adjacent non-instrumented levels.

A study of 242 adult spinal deformity cases found patients treated with ligament augmentation had significantly lower PJK and PJF complication rate as follows:

  • After one year, the reoperation rate for adult spinal deformity patients treated with ligament augmentation was just 3.3% compared to 15.6% of not treated with ligament augmentation.

The ligament augmentation technique aims to reduce the reoperation rate for PJF and its associated costs, which can be more than $50,000 per procedure.

The LigaPASS™ 2.0 system can also be paired with the UNiD™ Adaptive Spine Intelligence (ASI) platform. UNiD™ ASI is transforming the standard of care for patient-specific spine surgery by leveraging data science and artificial intelligence to help surgeons plan, execute and analyze their procedures. LigaPASS™ 2.0 system connectors and bands may also be used in conjunction with the CD Horizon™ Solera™ spinal system.

Clinician comments

“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 deformity surgery 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.”

Company comments

“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.

Source: Medtronic, Inc.

Share your thoughts

Your email address will not be published.