Ascendx Spine has announced it has received FDA clearance for a vertebral compression fractures repair system, according to a news release.
The Ascendx VCF repair system is designed to allow physicians to place a single bolus of bone cement in the center of the vertebra with the balloon still inflated.
The company previously received FDA clearance for its Ascendx Acu-Cut vertebral augmentation system.
"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, in the 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."
Ascendx Spine is headquartered in Winter Park, Fla.
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