Ascendx Spine Announces CE Mark Approval, ISO Certification for Orthopedic Products

Ascendx Spine has received ISO 13485 Certification and CE marking approval for its Ascendx VCF Repair System and its Acu-Cut Vertebral Augmentation System to treat vertebral compression fractures.

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In addition to its product approval and certification, Ascendx Spine has expanded its distribution networks into Germany, Austria, Switzerland, Italy, Portugal, Spain and France.

“We are expecting rapid market validation of our Ascendx VCF Repair System and the Acu-Cut Vertebral Augmentation System, both of which are designed for the treatment of spinal fractures,” said Ascendx Spine CEO Julian M. Mackenzie. “Our distribution partners in Europe will soon be able to offer spine surgeons and interventional radiologists a uniquely improved proprietary balloon kyphoplasty method designed to secure effective clinical outcomes for their patients with vertebral compression fractures.”

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