New Sizes of Interventional Spine’s Opticage™ Interbody Fusion System Get FDA Nod

Californian spinal implant maker Interventional Spine, Inc. has seen eleven additional sizes of its Opticage™ Expandable Interbody Fusion Device cleared by the U.S.FDA. The company says these new sizes will allow surgeons to match an Expandable Opticage to more than 80% of their patients requiring Lumbar Fusion surgery.

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 and MIS techniques. Supported by the Company’s unique product introduction systems, Interventional Spine’s products provide benefits to patients, surgeons and hospitals alike.

The Opticage Expandable Interbody Fusion Device features a continuously adjustable height within a working range of 9mm to 14mm. Since market release in mid-2012, there have been close to 1,000 implants of the Opticage™ worldwide, with exceptional clinical results. The device has benefitted patients in the United States, Spain, the United Kingdom, Italy, Brazil, Mexico and Chile.

Company comments

Mr. Walter A. Cuevas, Chief Executive Officer of Interventional Spine said: “With this milestone, Interventional Spine continues the practice of partnering with top surgeons around the world in providing the best solutions for patients. These new sizes expand the application of Interventional Spine’s technology to significantly more patients and increase the market penetration of the Opticage. In addition, due to its unique expansion properties, the Opticage Expandable Interbody Fusion Device provides an excellent alternative to surgeons performing lumbar interbody fusions, whether via percutaneous or MIS procedures. In fact, in combination with Interventional Spines’ PerX360 technology, the Opticage gives the surgeon the capability of performing a lumbar interbody fusion via a 12mm incision while protecting the surrounding nerves, which is unique in the world.”

Source: Interventional Spine, Inc., PR Newswire

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