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Home/Spine/Ascendx Spine Enters EU VCF Market
Spine

Ascendx Spine Enters EU VCF Market

October 8, 2012 1 min read Premium comments

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Ascendx Spine Enters EU VCF Market
Ascendx VCF Repair System Courtesy of Ascendx Spine
Secondary

Ascendx Spine is now in the market with their innovative line of vertebral compression fracture (VCF) repair products. Their system is brand named Ascendx VCF Repair System and Acu-Cut Vertebral Augmentation System. While it is not yet available in the United States the company has begun commercialization in Europe. “We have begun commercial shipments to Europe of our VCF repair which is designed for the treatment of vertebral compression fractures, “said Julian M. Mackenzie, Ascendx Spine CEO in the September 12 press release. The company’s distribution network includes Germany, Austria, Switzerland, Italy, Portugal, Spain, Turkey and France.

“Our distribution partners in Europe are now able to offer spine surgeons and interventional radiologists a uniquely proprietary balloon kyphoplasty method designed to secure effective clinical outcomes for their patients with vertebral compression fractures, ” Mackenzie added.

The company has conducted extensive clinical testing of the Ascendx VCF Repair System. One study, which can be found on the company’s website, was a prospective and multicenter evaluation of 60 subjects treated with the Ascendx System and the Ascendx cement. Patients in the study reported that they’d experienced pain relief and improved function and quality of life. In fact, according to the company, the improvement was significant while complications were minimal.

Ascendx Spine, based in Winter Park, Florida, is a medical device company focused on the development and commercialization of orthopedic devices for the spine and trauma markets. Its initial focus is the treatment of a vertebral compression fracture. A VCF forces a vertebra to collapse and the spinal column above it to assume an abnormal forward curve, resulting in back pain and a hunchbacked appearance.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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