FDA Approves Vertebral Augmentation System from Ascendx

Ascendx Spine is about to enter the U.S. medical device market.

Just three months after gaining approval in Europe to market two vertebral compression fracture (VCF) treatment products, the Winter Park, Fla.-based firm is preparing a commercialization strategy for its Acu-Cut Vertebral Augmentation System. The product was cleared by the U.S. Food and Drug Administration in late February.

Designed to treat spinal compression fractures, the Acu-Cut device is a uni-pedicular vertebral augmentation system designed to create a cavity for precise cement placement.

A VCF causes a vertebra to collapse and the spinal column above it to assume an abnormal forward curve, resulting in considerable back pain and a “hunchback” appearance. Current treatments for VCFs include vertebroplasty and kyphoplasty—both of which are minimally invasive procedures. In vertebroplasties, doctors use image guidance to inject a cement mixture into the fractured bone through a hollow needle; kyphohplasties, on the other hand feature a balloon that first is inserted into the fractured bone through the hollow needle to create a cavity or space. Cement is then injected into the cavity once the balloon is removed.

Traditional methods of VCF treatment require surgeons to pass next to both sides of the spinal cord in order to reach the entire vertebral body. The Acu-Cut system, however, can achieve such a feat through single-sided access, according to the company.

Shortly before Christmas last year, Ascendx Spine received CE Mark approval for the Acu-Cut system as well as the Ascendx VCF Repair System. The company tapped Paris, France-based distributor Spinaxis to oversee its marketing efforts in the country.

“We are very focused on market penetration throughout Europe of our Ascendx VCF Repair System and the Acu-Cut Vertebral Augmentation System, which are designed for the treatment of spinal fractures by spine surgeons and interventional radiologists,” Julian M. Mackenzie, Ascendx CEO, said when CE Mark approval was announced.