
National marketing has begun for the FDA-approved SAMBA Screw System a minimally invasive solution for the treatment of SI-Joint dysfunction, by Medical Designs LLC. Invented by Dr. Wilson Asfora, the SAMBA Screw System received clearance in August 2012 from the Food and Drug Administration (FDA) for sacroiliac joint fixation.
The SAMBA Screw System features:
- Technologically advanced hollow titanium bone screw with radial slots, which promote fusion by allowing osteogenic and osteoconductive material to flow into the SI-Joint.
- Custom instrument set permits guided placement of multiple SAMBA Screws across the SI-Joint in a time optimized minimally invasive procedure resulting in immediate SI joint stabilization with expeditious and comfortable post-operative course.
- SI-Joint fusion is enhanced by a unique precision-engineered applicator tool, which enables delivery through the SAMBA Screw pressurized insertion of demineralized bone, bone substitutes, or osteogenic material into the SI-Joint.
The inventor of the SAMBA Screw System, Dr. Asfora comments, “We have completed thirty SAMBA Screw procedures here in Sioux Falls, and the results have been outstanding. Our design team has optimized the surgical protocol to have fewer steps compared to other techniques. The result is less time in the OR and faster patient recovery.”
The cannulated design of the SAMBA Screw, with sharp bone cutting threads, is based on the Medical Designs Asfora Bullet Cage, a lumbar fusion device that has been implanted in hundreds of patients.
“We have achieved a remarkable 98% fusion rate with the Bullet Cage stand alone for one or two lumbar levels,” Asfora adds. “We expect a similar rate of success with the SAMBA Screw.”
According to a study by the Center for Spinal Stenosis and Neurologic Care, low back pain affects more than 90% of adults at some point and is the most common reason besides colds for primary care visits. Research conducted by the Department of Orthopedic Surgery at the University of Minnesota showed that up to 30% of patients presenting with low back pain had sacroiliac joint problems.
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