Ascendx Spine won FDA clearance for its Ascendx VCF Repair System, a device for treating vertebral compression fractures.
The Ascendx products are designed to reach the entire vertebral body via minimally invasive single-sided access, according to the press release.
"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," CEO Nick Curtis said in prepared remarks. "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.”
Current standard procedures for treating VCFs include vertebroplasty and kyphoplasty, which both require 2 access pathways near the spinal cord to reach the entire vertebral body, according to the press release.
The Ascendx VCF Repair System helps spine surgeons and interventional radiologists access treatment site via a single pathway, implanting a single bolus of bone cement in the center of the vertebra with the balloon still inflated, the company said.
Ascendx Spine last December started European commercialization of its Ascendx VCF repair system and its Acu-Cut vertebral augmentation system after winning CE Mark approval.