VertiFlex Commercially Releases Superion, A Percutaneously Delivered Interspinous Spacer

San Clemente, CA - VertiFlex Inc., a privately-held medical device company, has announced the commercial release of the Superion Interspinous Spacer to countries outside the USA. The Superion implant is placed percutaneously between the spinous processes without the need to cut paraspinal muscles. It is primarily designed to offer relief from neurogenic intermittent claudication and leg pain commonly associated with spinal stenosis. The company received a CE mark for Superion in 2007 and has been clinically testing the device at several centers outside the U.S. for the last several months. The product is currently not approved for use in the U.S.

The Superion Interspinous Spacer fundamentally changes the treatment paradigm for lumbar spinal stenosis and other indications of benefit by offering a less invasive surgical alternative. Unlike all other interspinous spacers currently on the market, the Superion surgical technique does not require damage or harm to any of the anatomical elements. A small incision is made posteriorly to the midline and the implant is delivered through a small cannula. The entire surgery is performed under local anesthesia and the average surgery time has been 25 minutes or less.

Dr. Reuven Gepstein, Director of the National Unit of Spine Institute, Israel, said, "I have implanted 15 Superions to date and am very impressed with the early results. I have documented substantially reduced pain scores in my patients and have had no associated complications to report." Dr. Gepstein went on to say, "The benefit of not cutting any muscle or ligament during implantation should result in higher efficacy and lower complication rates for patients. The Superion procedure is easily performed under local anesthesia, which enables me to treat patients that are not candidates for general anesthesia."

"We are excited to be releasing such a strong product offering to markets outside the U.S. Patients are clearly benefiting from interspinous spacer devices and we can now offer a product that is truly superior in both efficacy and safety to the current offerings," said VertiFlex CEO Keegan Harper.

VertiFlex is in the process of initiating a U.S. IDE trial for the Superion and anticipates starting the trial in quarter one of 2008.

SOURCE: VertiFlex Inc.