ApiFix Says Follow-Up Data Shows System Provides "Substantial Reduction" of Scoliosis.
M2 PHARMA-July 13, 2015-ApiFix Says Follow-Up Data Shows System Provides "Substantial Reduction" of Scoliosis
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US-based medical device maker ApiFix Ltd.'s ApiFix system, which has now been used to correct scoliosis in 50 adolescents since the system was approved for marketing in Europe, continues to demonstrate impressive results at one-to-three years of follow-up with 25 of these patients, the company said on Monday.
ApiFix is a commercial-stage company that has developed the CE-markedApiFix System, a non-fusion minimally invasive treatment alternative for Adolescent Idiopathic Scoliosis.
Scoliosis surgery is the most invasive procedure in spine. The average procedure fuses 10 vertebrae together using 20 screws, resulting in significant and permanent loss of spine mobility.
A clinical study of The ApiFix System led by Prof. Yizhar Floman, M.D. past president of the Israel Spine Society, published this year in the peer-reviewed medical journal Scoliosis concluded that there were many drawbacks to the current gold standard of AIS surgery, which are almost nonexistent with the use of ApiFix.
These drawbacks include the 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.
Almost all of these complications can be avoided by the use of Apifix, the report concluded.
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