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ApiFix marks 50-patient milestone with ApiFix System
Date Published：6/17/2015 01:06:06 PM
The CE-marked treatment for adolescent idiopathic scoliosis is being positioned as an alternative to AIS surgery
MARKING a company milestone, ApiFix Ltd has announced its ApiFix® System has been used to correct scoliosis in 50 adolescents since obtaining approval for marketing in Europe.
The CE-marked ApiFix System from commercial-stage company ApiFix is a non-fusion minimally invasive treatment alternative for Adolescent Idiopathic Scoliosis (AIS). A related clinical study published this year in the peer-reviewed medical journal Scoliosis concluded many drawbacks to the current gold standard of AIS surgery are almost nonexistent with the use of ApiFix. These include considerable blood loss leading to blood transfusions, neurologic deficit including spinal cord lesions, late infections, pseudoarthrosis, limitation of spinal motion also affecting non-fused levels, back pain, and disc degeneration in the non-fused spinal segments.
Scoliosis surgery, the most invasive procedure in spine, requires fusing 10 vertebrae together using 20 screws in an average procedure. This results in significant and permanent loss of spine mobility.
Uri Arnin, CEO, headquartered in Misgav, Israel, acknowledges the clear and urgent need for an alternative to today’s standard for scoliosis correction in adolescents 12 to 18 years old, which is when rapid growth typically occurs.
“In 80 percent of these children, the cause of their scoliosis is ‘idiopathic’, or unknown. While the reduction in spine mobility is certainly a difficult consequence of long spinal fusions, which are the gold standard of treating scoliosis today, other critically important negative consequences include high chance for back pain and additional spine surgery during the first 20 years post-original surgery,” Mr. Arnin said.
Ted Bird, chairman, based in Charleston, S.C., USA, notes the advantages of using the ApiFix system.
“It is approved for sale in Europe. We are currently raising funding in order to fast-forward our sales-and-marketing efforts to launch a device that is designed to be a new standard for correcting scoliosis in adolescents,” Mr. Bird stated.Nike Air Max