Zavation Medical Products, LLC announces launch of Varisync® ALIF System

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Sep 10, 2024, 10:00 ET

FLOWOOD, Miss., Sept. 10, 2024 /PRNewswire/ -- Zavation Medical Products, LLC ("Zavation"), an innovator in spinal device technology, proudly announces the launch of its latest product—the Varisync^® ALIF System. Engineered to streamline ALIF procedures, the Varisync system offers customization and efficiency with two spacer fixation options: anchors and screws.

Innovative Features:
The Zavation Varisync ALIF System provides unique anchor fixation in fewer operative steps than traditional screw fixation methods and through a less invasive surgical corridor. Its advanced instrumentation allows for the simultaneous deployment of three pre-loaded anchors through a small, protected working corridor no wider than the smallest width Varisync ALIF cage. This innovative anchor fixation method serves as a valuable alternative to traditional screw fixation, particularly in challenging surgical scenarios where screw instrumentation angulation is impeded by patient anatomy, such as when the sacral slope limits access to certain lumbar spine levels.

Clinical Feedback:
Dr. Hanbing Zhou, MD, a fellowship-trained orthopedic spine surgeon practicing at the Bone & Joint Institute at Hartford Hospital in Hartford, CT, utilized the Varisync ALIF System. This inaugural case took place in early August 2024. Dr. Zhou noted, "The Varisync ALIF System significantly reduces procedural complexity with its new anchor-based fixation. Its innovative design and efficient deployment make it a game-changer in ALIF procedures. In addition, the 3D Printed Mimetic Metal technology's porous design provides conduits for osteointegration".

Patented Mimetic Metal^® Technology:
The Zavation Varisync ALIF System incorporates patented Mimetic Metal® cage technology in the F3D-Z Varisync ALIF spacers. This advanced technology is designed to emulate natural bone with a directional lattice architecture and trabecular pores. In-vitro studies have demonstrated that Mimetic Metal significantly increases osteoblast activity compared to machined solid titanium, PEEK, and HA-PEEK. Additionally, in-vivo studies have shown remarkable bony in-growth and on-growth in both cortical and cancellous bone^*.

Versatile Spacers:
The system's spacers come in three standard footprints: 24x30, 26x35, and 28x40, with heights ranging from 11mm to 17mm and angles of 8 and 15 degrees. Taller height and hyperlordotic options (20 and 25 degrees) are also available within the system, catering to a wide range of surgical needs and patient anatomies.

^*Data on file, pre-clinical data may not be representative of clinical results.

Contact Zavation for more information on Zavation's Varisync ALIF System.

Indications for Use: The Zavation Varisync ALIF System is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Zavation Varisync ALIF System is to be filled with autogenous bone graft material. The Zavation Varisync ALIF System spacer and plate assembly are an integrated fusion device intended for standalone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (>20 degrees) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.

About Zavation Medical Products, LLC: Based in Flowood, MS, Zavation designs, engineers, and manufactures a portfolio of spinal hardware and biologics covering key areas including cervical, thoracolumbar, interbody fusion, interventional spine, and minimally invasive surgery. Founded in 2012, Zavation has experienced exceptional growth and created a national network of numerous distributors across the United States. The Company has commercialized over 25 product families since inception. Zavation operates a newly constructed 75,000 square foot vertically integrated facility in Flowood, MS. To learn more information about Zavation and the Company's suite of products, visit www.zavation.com.

SOURCE Zavation Medical Products, LLC.