Interventional Spine announced FDA clearance of its 80 Lumbar Lordotic Opticage Expandable Intervertebral Body Fusion Device.
This device joins the Interventional Spine family of Opticage™ Expandable Interbody Fusion Devices previously cleared late last year, and also used with the Company’s PerX360 System.
The Lordotic 80 Opticage™ is a lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1.
Lumbar Lordosis is a condition in which the spine in the lower back tends to curve more than what is normal. As a result of the abnormal curvature of the lower back, increased pressure is put on the lower spine resulting in pain for the patient.
The new Lordotic 80 Opticage™ is an option that surgeons may use to help correct the pressure on the lower spine potentially alleviating the pain that patients experience as a result of lordosis. The new Opticage provides options to be implanted via posterior, transforaminal or lateral approach.
In addition, the Lordotic 80 Opticage™ will provide for optimum graft injection through its patented delivery system.
Interventional Spine is currently in the process of assessing other sizes and configurations for its line of Lordotic Expandable Opticages.
Joseph Darling, Interventional Spine’s Chief Operating Officer commented, "Based on existing market trends, Interventional Spine expect the new Lordotic Opticages to be a significant source of revenue for the company. More and more surgeons have been requesting a Lumbar Lordotic expandable cage from us.
"We are very excited with the latest addition of the Lordotic 80 Opticage, as it provides a pathway for Interventional Spine’s vision of becoming a leader in the expandable cage market, and addresses the needs of Surgeons and Patients world-wide."
Interventional Spine, Inc. is a privately held company based in Irvine, California, that designs, develops, and markets patented implantable devices for the spine that can be deployed via both surgical and minimally invasive techniques.
Supported by the Company’s unique product introduction systems, Interventional Spine’s products provide benefits to patients, surgeons, and healthcare facilities alike.