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FDA clears two devices to treat vertebral compression fractures

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Ascendx Spine, Inc. announced that it has received FDA 510(k) clearance for both its Ascendx VCF Repair System and its Ascendx Acu-Cut Vertebral Augmentation System to treat vertebral compression fractures. Both products are also approved for marketing in Europe.

According to a press release, these products are designed to achieve reaching the entire vertebral body through minimally invasive single-sided access. The system is designed to enable physicians, spine surgeons and interventional radiologists to place bone cement 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,” Julian M. Mackenzie, CEO of Ascendx Spine, stated in a press release. “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.”