Recent studies published in the New England Journal of Medicine suggest that the benefits patients derive from vertebroplasty is merely a placebo effect, although some spine interventionalists have criticised the design of these studies.
Against the backdrop of this raging debate, Medtronic has just launched the KYPHON Express System in Europe. This is a set of devices for the KYPHON balloon kyphoplasty procedure to treat vertebral compression fractures.
At the recent CIRSE 2009 conference, Lisbon, Portugal, some interventionalists asid they seem to prefer the kyphoplasty procedure which has the potential of providing added safety and a more consistent filling of the vertebral body with bone cement. Others have criticised the design of the studies in the NEJM in relation to their inclusion and exclusion criteria and population size, amongst other things.
Medtronic has said that newly introduced Kyphoplast Express System has tools, which are smaller than what is currently available for balloon kyphoplasty.
A company release says, according to a recently published study in The Lancet, patients whose VCFs are treated with balloon kyphoplasty experience significant improvement in quality of life, back function and back pain compared to patients receiving non-surgical management (including pain medication, bed rest, physiotherapy and back bracing) alone.
The Express System measures only 3.3mm in diameter, more than 20% smaller than devices currently available in Europe for the balloon kyphoplasty procedure. The smaller size may offer advantages in the treatment of smaller patients, such as petite women, and allows treatment of fractures in the upper thoracic area of the spine. Some 10-15 percent of VCFs are upper thoracic fractures2, which, until now, had some treatment limitations due to size availability of the balloon kyphoplasty devices.
Hendrik Fransen, from the Radiology Department of the AZ Sint Lucas hospital in Gent, Belgium said, “The KYPHON Express System will help us to make balloon kyphoplasty available to more patients. The KYPHON Express System was developed by Medtronic in direct response to physician requests for smaller-sized devices. This is good news, as we will now be able to perform this procedure more widely, which may improve the lives of more patients.”