Wenzel Spine, Inc., a medical technology company focused on minimally invasive surgical and analytic solutions for spinal disorders, announced it has received FDA clearance for its revolutionary expandable sacroiliac (SI) fusion implant, panaSIa. This milestone marks the first ever FDA clearance of an expandable SI fusion implant, offering a novel, minimally invasive solution for patients suffering from sacroiliac joint dysfunction.
“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.”
The panaSIa SI Fusion System represents a strategic expansion of Wenzel Spine’s portfolio of stand-alone expandable devices. Backed by over 17 years of expertise in expandable implant design and manufacturing, panaSIa delivers a unique solution for a historically underserved patient population.
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“For my patients, the implant distracts the joint space and relieves arthritic pain by separating the joint surfaces,” said Dr. Charley Gordon, a prominent neurosurgeon. “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.”
The implant offers a minimally invasive approach for SI joint stabilization, providing rapid recovery, reduced risk of complications, and durable pain relief. panaSIa’s FDA clearance positions Wenzel Spine as a category leader in a fast-growing SI fusion market segment.
Source: Businesswire