FDA Clearance For Opticage Expandable Intervertebral Body Fusion Device

“This approval provides Interventional Spine with a unique technology, capable of transforming how lumbar spine fusion is performed. In turn, our patients will experience less pain, shorter hospital stays and better outcomes overall.”

Abstract

Interventional Spine, Inc. has announced the FDA clearance of its Opticage™ Expandable Intervertebral Body Fusion Device.

Background

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 percutaneous techniques.

The Opticage™ Expandable Interbody forms an integral part of Interventional Spine’s revolutionary PerX360 System™ in combination with Interventional’s Optiport™ Access Instrument, which provides unparalleled percutaneous access to the disc space. According to the company this is the first and only system in the world capable of providing surgeons with the ability to perform a complete percutaneous lumbar interbody fusion via two 15mm incisions for the treatment of lumbar discogenic pain.

To date, the PerX360 System™ has been used internationally on over 20 patients, under local anesthesia, with excellent results.

Clinician comments 

Dr. David L. Greenwald, Flagler Brain and Spine Institute in St. Augustine, Florida, commented: “This is a significant milestone in the progression of making lumbar spinal fusion surgeries less invasive to patients. No other company has the cadre of technologies that allow surgeons to perform a full lumbar fusion via two 15mm incisions. To my knowledge, no other interbody fusion cage in the market has the expansion capabilities of the Opticage™. Because of this characteristic, the channel for insertion is reduced and will help minimize tissue trauma and decrease the patient overall recovery times. This is the future of spinal surgery,” concluded Dr. Greenwald.

Dr. Cully White, Neurosurgery and Spine, S.C., in Milwaukee, Wisconsin, commented: “This approval provides Interventional Spine with a unique technology, capable of transforming how lumbar spine fusion is performed. In turn, our patients will experience less pain, shorter hospital stays and better outcomes overall.”

Company comments 

Mr. Walter A. Cuevas, Chief Executive Officer of Interventional Spine said: “This is a major milestone for the company and gives recognition to the countless hours our team, working together with Dr. Rudolf Morgenstern in Barcelona, spent in perfecting this innovative technology. We now look forward to partnering with surgeons in the United States to make this technology available to them in a manner that will benefit their patients.”

Source: Interventional Spine Inc