Over 400 spine surgeons were trained in the basic technique at the North American Spine Society (NASS) convention in Austin, TX last month.
"We believe that this milestone is a reasonable predictor that TruFUSE has the potential to achieve broad acceptance as an early stage surgical solution for back pain sufferers," said James Doulgeris, minSURG''s president and CEO.
To support the increase in surgeon users, minSURG has added 21 new domestic regional spine distributors with over 300 additional sales representatives as of today, providing almost complete coverage in the U.S.
"We believe that refinements in the technique and instrumentation provide reliable results with minimum risk and recovery time for patients. That, in conjunction with excellent results from our first study prompted us to release TruFUSE for general distribution in the U.S.," Doulgeris continued.
The TruFUSE minimally invasive back pain alternative uses two small cork- shaped dowels, called allografts, made from human bone, to stop painful spinal facet joints from moving. The dowels are inserted with minimally invasive, minimally destructive techniques between facet joints in the back to stop movement and pain. The TruFUSE technique fills the large void between traditional non-surgical pain management and major surgery.
A retrospective chart review of 81 patients was performed revealing good to excellent pain relief in more than 90% of patients at six weeks postoperatively. Fewer than 5% of patients following up at three months continued to complain of severe pain. The most frequently encountered complication relates to dowel migration, which was observed in 8.6% of patients. Only one of the seven migration cases required revision surgery for recurrence of back pain. There were no serious complications noted.
TruFUSE represents a new surgical option for many back pain sufferers who do not yet qualify for major surgery. It may be used to treat a variety of back problems, including augmentation of other procedures for any location from C2-C3 to L5-S1. Compared to many existing methods, TruFUSE is generally less invasive, less destructive, less complicated, less expensive and subjects the patients to relatively minimal risk.
TruFUSE has been used on select patients since March 2006, and went into limited distribution in August 2006.
For more information on TruFUSE, please visit the Web site at or call (813) 318-0565 ext. 216.
Source: minSURG Corporation