FDA OKs Wenzel Spine’s panaSIa Expandable SI Fusion Implant

Wenzel Spine, a company focused on minimally invasive surgical and analytic solutions for spinal disorders, has earned U.S. Food and Drug Administration (FDA) clearance for its panaSIa expandable sacroiliac (SI) fusion implant.

According to the company, this achievement marks the first FDA clearance for an expandable SI fusion implant. It offers a new, minimally invasive solutions for patients with SI joint dysfunction.

panaSIa is backed by more than 17 years of expandable implant design and manufacturing, the company said. It delivers a solution for a historically underserved population of patients.

Dr. Charley Gordon, a prominent neurosurgeon said that for his patients, the implant distracts the joint space and relieves arthritic pain by separating the joint surfaces.

“Its immediate post-deployment stability also minimizes micro-motion in the joint, which provides immediate fixation and relief all while stabilizing the joint for fusion,” Dr. Gordon told the press.

The system’s expandable architecture lets the implant pierce the ilium and sacrum to stabilize the SI joint and enable post-expansion graft delivery without disengaging the instrumentation. It’s available in two implant sizes so surgeons can tailor procedures to individual anatomy.

panaSIa is available now through a limited commercial launch, with full availability expected in Q4 of this year.

“We are excited to bring this transformative innovation to market,” said William Wilson, CEO of Wenzel Spine. “FDA clearance for the panaSIa SI Fusion System reflects our continued commitment to improving patient outcomes through advanced, expandable technologies that meet the evolving needs of both surgeons and their patients.”

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