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VertiFlex®, Inc. Announces First Patient Successfully Treated with the Totalis™ Direct Decompression System

Mon, 03/18/2013 - 12:33pm
The Associated Press

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Mar 18, 2013--VertiFlex®, Inc., a leading innovator of advanced minimally invasive spinal surgery technologies , today announced successful completion of the first Totalis™ Direct Decompression procedure, performed by Dr. Eric Grigsby at the Napa Surgery Center on March 1, 2013.

The Totalis™ Direct Decompression System is a unique set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. The system utilizes VertiFlex ’ proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal conditions such as lumbar stenosis. The procedure involves a small single midline incision and sequential dilation to a working cannula about the size of a dime. Specialty instruments designed for precision and safety are then used to remove the targeted tissue. The procedure provides physicians the ability to remove ligament, bone, and facet capsule material to address both central and lateral recess stenosis. This broad decompression involves minimal collateral tissue disruption and can be performed under local anesthesia. The Totalis™ Direct Decompression System was 510(k) cleared by the FDA in November, 2012.

“We are very pleased with the development of Totalis ™ and the achievement of its successful first surgery,” said Earl R. Fender, President and Chief Executive Officer of VertiFlex, Inc. “The procedure offers the best of both worlds in that it enables spine clinicians the ability to safely perform broad lumbar decompressions in a minimally invasive approach. For patients, it means the likelihood of greater pain relief and faster recovery.” "One of our biggest challenges in treating spinal stenosis is removal of the ligament which causes narrowing of the spinal canal, without further destabilizing the spine,” commented Dr. Grigsby. “The Totalis™ system allows a more thorough resection of the offending ligament than other minimally invasive options, and still leaves the structural elements of the lumbar spine intact. It's a very significant advancement in the treatment of spinal stenosis, and the evolution of minimally invasive spinal surgery overall." About VertiFlex®, Inc. VertiFlex® is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in San Clemente, CA, VertiFlex® has developed a proprietary, minimally invasive interspinous access platform for performing both indirect and direct decompressions of the lumbar spine. These technologies fill the MIS procedural gap in the stenosis treatment continuum between conservative care and traditional spine surgery. This provides new options for interventional spine physicians and less invasive options for traditional spine surgeons to treat patients who would otherwise undergo more invasive surgery. To date, VertiFlex® has compiled the largest, most rigorous, body of device clinical evidence, related to lumbar spinal stenosis.

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