Custom Spine Announces 510k Clearance of Pathway AVID
PARSIPPANY, N.J., Oct. 22 Custom Spine, a pioneering leader in the development of spine treatment solutions, announced today that Pathway AVID(TM) (articulating vertebral interbody device) has received 510k Clearance from the U.S. Food and Drug Administration (FDA). Pathway AVID is the latest addition to a line of advanced implants and instrumentation offered by Custom Spine.
Pathway AVID consists of three intra-linked spacers made from PEEK-OPTIMAŪ, which are inserted into the disc space using a transforaminal approach. Once inside the disc area, two spacers are sequentially articulated using the customized AVID inserter to create an interbody that follows the natural curvature of the vertebra.
The large footprint of 35 mm long by 20 mm wide in the articulated position provides maximum surface area contact to increase stability and support, while reducing the risk of subsidence. Pathway AVID was designed to compliment Custom Spine's flagship spinal fixation system, ISSYS LP.
"We are excited to bring this unique interbody spacer to the market and believe this device may facilitate a quicker recovery for the patient when compared to traditional TLIF spacers," said Lew Bennett, President of Custom Spine. "The addition of Pathway AVID further demonstrates the company's commitment to developing a full line of spinal products that offer unique benefits to both the patient and surgeon."
Pathway AVID's symmetrical design provides greater load distribution across the vertebral body. This design, combined with a maximum graft surface area both within the implant and posterior to the device, allows for the addition of significant amounts of autogenous bone graft to better promote bone growth.
About Custom Spine
Custom Spine, Inc. is a pioneering leader in the spine market creating the next generation of surgeon-friendly spinal implants and instruments that provide superior performance and patient care. The company was founded by top engineers and industry professionals in partnership with orthopedic and neurological spine surgeons to develop advanced medical solutions. Custom Spine (www.customspine.com) is a privately held company headquartered in Parsippany, New Jersey.
SOURCE Custom Spine
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