Boston Scientific Announces One-Year Results In The VANTAGE Clinical Study Evaluating The Vercise™ DBS System
Data Presented at the 18th International Congress of Parkinson's Disease and Movement Disorders Demonstrate Highly Significant Improvement in Motor Function for Patients with Parkinson's Disease
Jun 11, 2014
Patients with Parkinson's disease (PD) treated with the Boston Scientific Corporation (NYSE: BSX) Vercise™ Deep Brain Stimulation (DBS) System demonstrated a highly significant and consistent improvement in motor scores, according to the latest one-year data.
VANTAGE is a prospective, multi-center trial evaluating the Vercise DBS System assessing patient outcomes in PD, including effectiveness, safety and health economic data. Forty patients with PD were treated with the Vercise DBS System at six European centers.
Results of the follow-up were presented at the 18th International Congress of Parkinson's Disease and Movement Disorders in Stockholm, Sweden by Prof. Dr. Lars Timmermann, of University Hospital in Koln, Germany.
The VANTAGE study reported a 62 percent improvement in motor function at 12 months post implant, as assessed by the UPDRS III1 scale, when compared to baseline. This result is consistent with the six month interim data presented last year, demonstrating that patients benefitted from therapy over time. In addition, patients reduced medication usage by 58 percent at 12 months compared to their usage prior to the DBS procedure.2
"We are pleased to see not only a highly significant improvement in motor function over the longer term, but also a highly significant improvement in overall quality of life for the VANTAGE study patients3," said Prof. Dr. François Alesch, professor for Stereotactic and Functional Neurosurgery at Medical University, Vienna, Austria and neurosurgical principal investigator of the trial. "I believe these results are rooted in the Vercise DBS System's multiple independent current control technology, which is designed for accurate neural targeting to improve patient outcomes and minimize the side effects of unwanted stimulation."
"We look forward to following these VANTAGE study patients over the next five years, especially since the Vercise DBS System is the only rechargeable DBS platform with a battery life of 25 years," said Prof. Dr. Lars Timmermann, neurological principal investigator of the trial. "With this system, patients will not need to undergo battery replacement surgery every few years and can expect to benefit from their therapy over time."
"We are pleased to see that the one-year VANTAGE study data deliver highly significant results, reinforcing our belief in the clear advantages of our Vercise DBS technology," said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. "We are committed to demonstrating the clinical value of our differentiated innovations with a cadence of clinical data releases including VANTAGE, the CUSTOM-DBS study, and the ongoing Vercise Registry."
DBS is a surgical treatment that can help reduce some PD symptoms. It involves the placement of a device that stimulates specific areas of the brain using electrical signals. DBS is typically used to treat people with advanced PD whose symptoms are no longer controlled by medication. PD is a progressive neurological disorder which affects 6.3 million people worldwide4.
Boston Scientific is an innovation leader in implantable DBS technology. The Vercise DBS System has both CE Mark and TGA (Australia Therapeutic Goods Administration) approval and is available for sale in Europe, Israel, Australia and select countries in Latin America for PD, and has CE Mark approval for intractable primary and secondary dystonia.
In the U.S., the Vercise DBS System is investigational and not available for use or sale. The INTREPID clinical trial began enrollment in the U.S. in mid-2013 to evaluate the safety and effectiveness of the Vercise DBS System for the treatment of Parkinson's disease.
- Unified Parkinson's Disease Rating Scale Part III (UPDRS III)
- Calculated using levodopa equivalents
- Quality of life assessed with the Parkinson's Disease Questionnaire (PDQ-39) Schwab and England and motor diaries
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1 European Parkinson’s Disease Association 2013. https://www.epda.eu.com/en/about-the-epda/ Date accessed 4 December 2013.
2 Parkinson’s Disease Foundation 2012. https://www.pdf.org/en/parkinson_statistics Date accessed 12 November 2013.
3 European Parkinson’s Disease Association 2013. https://www.epda.eu.com/en/about-the-epda/ Date accessed 4 December 2013.
4 Dystonia Europe. Dystonia. https://dystonia-europe.org/about-dystonia/dystonia/ Date accessed 14 November 2013.
5 Epidemiology study of dystonia in Europe (ESDE) Collaborative Group. A prevalence study of primary dystonia in eight European countries. J. Neurology. 2000. 247:787-792.