MIS spinal implant company Medical Designs, LLC, has announced the FDA clearance and launch of its SAMBA™ Screw System. Designed by South Dakota neuro/spinal surgeon Dr Wilson Asfora, the SAMBA™ Screw System received FDA 510(k) clearance last August (2012) and is indicated for sacroiliac joint fixation.
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 with up to 30% of patients presenting with low back pain had sacroiliac joint problems.
The SAMBA™ Screw System is a technologically advanced hollow titanium bone screw with radial slots which promote fusion by allowing osteogenic and osteoconductive material to flow into the SI-Joint.
The company says the system’s 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.
Furthermore, it claims SI-Joint fusion is enhanced by a unique, precision-engineered applicator tool which enables pressurized insertion of demineralized bone, bone substitutes, or osteogenic material into the SI-Joint through the SAMBA™ Screw itself.
Medical Designs, LLC intends to distribute the SAMBA™ Screw System through a network of independent reps and distributors.
The inventor of the SAMBA™ Screw System, Dr. Wilson Asfora commented, “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 which 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,” added Dr. Asfora. “We expect a similar rate of success with the SAMBA™ Screw.”
Source: Medical Designs, LLC., Business Wire