AUDUBON, Pa. (October 20, 2011) – Globus Medical, Inc., the largest privately held spinal implant manufacturer in the world, today announced its support of a major initiative of the Society for Minimally Invasive Spine Surgery (SMISS) to create the first ever prospective registry evaluating the effect of minimally invasive spine surgery on patient outcomes.
Globus has agreed to fund the establishment of the SMISS Data Registry for the Treatment of Degenerative Lumbar Spondylolisthesis, Degenerative Disc Disease, Spinal Stenosis, and Degenerative Scoliosis. The registry will capture prospective clinical data from 10 to 15 clinical sites throughout the country, up to 250 patients, utilizing an electronic data capture program which will allow for “patient portals” to facilitate data collection from anywhere an internet connection is available. Patients will be followed for a minimum of 24 months looking at Health Related Quality of Life (HRQOL) and Quality Adjusted Life Years (QALY) outcomes, the rate and incidence of peri-operative and post-operative adverse events, radiographic correction and fusion rates as well as cost of treatment with the MIS approach.
Dave Demski, President and Chief Operating Officer of Globus Medical, commented: “We have, as a company, historically supported the advancement of minimally invasive spine procedures with novel products such as our MARS™ 3V retractor system and our Caliber™ expandable TLIF cage, combined with a very unique progressive surgeon educational program featuring the Skin-2-Skin® programs. This commitment makes this support of SMISS, the pre-eminent minimally invasive society, a logical step for Globus.”
Choll Kim, M.D., PhD, Executive Director of SMISS noted: “Many surgical procedures have evolved to utilize minimally invasive approaches to treat a myriad of conditions, and for some, such as endoscopic ACL repair, the minimally invasive approach is the standard of care. The absence of prospective data on minimally invasive spine procedures leaves advocacy based on expert opinion and we believe that this multicenter effort will change that. SMISS is pleased to count Globus Medical as a supporter of this initiative and minimally invasive surgery overall”.
The registry will be formally announced in conjunction with the annual meeting of SMISS to be held October 21st – 23rd in Las Vegas, NV.