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Ascendx Spine Receives FDA 510(k) Clearance for Its Ascendx VCF Repair System


12/19/2012 8:42:35 AM

December 19, 2012 -- Ascendx Spine™, Inc., (www.ascendxspine.com) has received FDA 510(k) clearance for its Ascendx VCF Repair System. Previously, the Company has received FDA clearance for its Ascendx Acu-Cut Vertebral Augmentation System. Both products, which are used to treat vertebral compression fractures (VCF), are also approved for marketing in Europe.

A vertebral compression fracture forces a vertebra to collapse, and the spinal column above it to assume an abnormal forward curve, resulting in considerable back pain and a hunchbacked appearance. Current standard procedures for treating VCFs are ‘vertebroplasty’ and ‘kyphoplasty.’ While traditional technologies require passing next to both sides of the spinal cord to reach the entire vertebral body, the Ascendx products are designed to achieve this through minimally invasive single-sided access.

The Ascendx VCF Repair System is designed to enable the physicians, including spine surgeons and interventional radiologists, to place a single bolus of bone cement (PMMA) in the center of the vertebra with the balloon still inflated.

“We are extremely pleased that both of our products, the Ascendx VCF Repair System and the Ascendx Acu-Cut Vertebral Augmentation System, are now FDA-cleared and CE-marked,” said Julian M. Mackenzie, CEO of Ascendx Spine™. “We look forward to commencing the commercialization of both products in the United States and Europe via a hybrid strategy of select spine distributors and a direct sales force.”

About Ascendx Spine™

Based in Winter Park, Florida, Ascendx Spine™, Inc., is a medical device company focused on the development and commercialization of innovative orthopedic devices for the spine and trauma markets.



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