Ascendx Spine has received ISO 13485 Certification and CE mark approval for its Ascendx VCF repair system and its Ascendx Acu-Cut vertebral augmentation system to treat vertebral compression fractures.
Current standard procedures for treating vertebral compression fractures are vertebroplasty and kyphoplasty. While the Ascendx VCF repair system accesses the vertebral body in a similar manner to the traditional therapies, this system enables precise placement of the cement at the site of the fracture while the balloon is still inflated.
The company has a 510(k) submission pending FDA clearance for its Ascendx VCF repair system in 2011. To support this approval a 60-patient, multicentre US clinical trial has been completed.