Endius announced FDA clearance of its 510(k) submission to market expanded capabilities of its single, fully integrated Atavi Atraumatic Spine Fusion System to perform lumbar interbody fusion, using a minimally invasive, endoscopic approach which does not change the traditional open surgical technique. Endius' new MiLIF procedure (Minimally Invasive Lumbar Interbody Fusion) includes the introduction of the Endius MiCOR Precision Bone Allograft and specialized Atavi instrumentation.

MiCOR, machined bone allograft specially designed for endoscopic delivery using the Endius Atavi System, was developed through an exclusive agreement with TissueNet. TissueNet is a leading provider of allograft bone products that are available through a national network of tissue banks accredited by The American Association of Tissue Banks (AATB). The Endius MiCOR line, delivered via the Atavi System, allows surgeons to restore disc height and provide additional spinal column support to treat advanced stages of degenerative spine disease endoscopically -- using one system, one access portal, and without changing the fundamentals of the open surgical technique.

Endius is also announcing expanded capabilities of its Atavi System that include the new Atavi TiTLE top-loading rod fixation system, which enables single- and two-level fusion and fixation; enhanced endoscopic visualization capabilities; and the Atavi endoscopic decompression technique. Surgeons, for the first time, will now be able to treat nearly 80 per cent of all patients requiring lumbar spine fusion with a minimally invasive approach by early 2003 - using this single, integrated surgical system, and one small incision on each side of the spine during the entire procedure.

"This exclusive agreement with TissueNet is significant for the industry, and positions Endius at the forefront of improving surgical outcomes in the minimally invasive treatment of serious spine ailments," said Don Grilli, chairman and CEO, Endius. "Endius' business model enables us to be nimble, and invest in innovative, yet proven, solutions with both short- and long-term market potential. Within recent months, Endius has achieved significant regulatory milestones. This momentum and rapid expansion of our indications can be attributed to Endius' solid industry track record, and the fact that we do not change the fundamentals of the tried and true open fusion procedure."

In this exclusive partnership, Endius and TissueNet worked closely together to design MiCOR for use as a lumbar interbody fusion device for Endius' MiLIF procedure. Specifically developed for endoscopic delivery using Atavi, MiCOR provides one of the main structural components in the interbody disc space.

"Endius is taking minimally invasive spine fusion to a new level and is the most innovative spine surgery company I've seen in the industry," said Alan Novotony, CEO, TissueNet. "Working closely together, we successfully designed and developed a new line of specialty implants that can be delivered using Endius' endoscopic, minimally invasive approach. We feel that providing Endius-trained surgeons with access to our national network of tissue banks is extremely significant -- not only in helping to improve surgical outcomes, but also by decreasing the time and resources typically required to locate, match and acquire allograft tissue from a trusted source for use in the surgical environment."

Atavi combines unique access technology, and sophisticated endoscopic visualization and instrumentation capabilities, to enable surgeons to perform a complete posterolateral lumbar spine fusion -- including preparation of the fusion bed, delivery of bone graft and placement fixation devices - along with the ability to place a spinal implant and perform decompression, endoscopically and through the same access portal -- all with a single, integrated system.