Higher Survival Rate Shown In Patient Group Receiving Minimally Invasive Surgery For Spinal Fractures Than In Group Treated Non-Surgically

Medtronic, Inc. announced yesterday the results of a retrospective claims-based data analysis suggesting that a patient group of those over 65 in the U.S. whose spinal fractures were treated with minimally invasive surgery had a higher survival rate up to four years after treatment than a patient group that did not have surgery. The evaluation is pending U.S. Food and Drug Administration (FDA) review of the claims.


The data further suggested that of the patient group treated with one of the two minimally invasive surgical procedures available, a sub-group treated with balloon kyphoplasty had higher survival rate up to four years after treatment than a sub-group that was treated with vertebroplasty. During the evaluation period, Kyphon® Balloon
Kyphoplasty was the only balloon kyphoplasty treatment for spinal fractures cleared by the FDA in the U.S.


This first longitudinal, population-based comparison of mortality risk between operated and non-operated patient groups with spinal fractures and between balloon kyphoplasty and vertebroplasty patient sub-groups was published online recently in The Journal of Bone and Mineral Research.i


In the evaluation, researchers looked at data from the U.S. Medicare dataset including a population of 1 million patients that suffered vertebral compression fractures from 2005 through 2008. After inclusion criteria were applied, a population of 858,978 spinal fracture patients was analyzed. The population included 119,253 or 13.9% treated with balloon kyphoplasty, 63,693 or 7.4% treated with vertebroplasty and the remaining treated only with non-surgical care such as pain medication, bed rest, physiotherapy or bracing.


While an estimated 1.4 millionii debilitating and painful spinal fractures are suffered annually worldwide, prior to this evaluation the association between surgical treatment for these painful fractures and survivorship was unknown.


The evaluation was jointly carried out by Exponent, Inc., a scientific and engineering consulting firm and Medtronic, the balloon kyphoplasty market leader with over 900,000 spinal fractures worldwide treated with Kyphon Balloon Kyphoplasty.


Among the findings of the evaluation at up to four years follow-up were:



The patient group whose spinal fractures were treated surgically with either balloon kyphoplasty or vertebroplasty had a statistically significant higher adjusted survival rate of 60.8% compared to 50.0% for the patient group
undergoing conservative or non-surgical care (p

The improved survivor rate of the group treated with minimally invasive surgery was confirmed by an analysis of a sub-group of these patients who were alive one year after their initial diagnosis of a spinal fracture. This group was 18% less likely to die by the end of the study than those in the non-surgical group (p