IRVINE, California, January 26, 2012 /PRNewswire/ --
Interventional Spine, Inc. today announced the FDA clearance of its Opticage(TM) Expandable Intervertebral Body Fusion Device.
With the Optiport(TM) Access Instrument, which provides unparalleled percutaneous access to the disc space, the Opticage(TM) Expandable Interbody forms an integral part of Interventional Spine's revolutionary PerX360 System(TM). This is the first and only system in the world capable of providing surgeons 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(TM) has been used internationally on over 20 patients, under local anesthesia, with excellent results.
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(TM). 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.
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."
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."
Interventional Spine(R), 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. Supported by the Company's unique product introduction systems, Interventional Spine's products provide benefits to patients, surgeons and hospitals alike. This system joins their current product offerings; the PERPOS(R) PLS System, the PERPOS(R) Percutaneous Cervical System, and the PDS System(TM).
More information on the Company and its products can be found at: http://www.i-spineinc.com
Interventional Spine, Inc.