Boston Scientific is trumpeting new one-year data suggesting that its Vercise™ Deep Brain Stimulation (DBS) System demonstrated a highly significant and consistent improvement in motor scores in patients with Parkinson’s disease (PD).
Background
It’s getting on for two years since we covered the news that Boston’s Vercise DBS system had gained CE mark approval for use in the reduction of symptoms of Parkinson’s disease. Treatment involves the placement of the 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.
In the U.S., the Vercise DBS System is investigational and not available for use or sale.
The newly reported 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 study reported a 62 percent improvement in motor function at 12 months post implant, as assessed by the UPDRS III 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.
Physician comments
“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.”
Company comments
“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.”
Source: Boston Scientific Corporation, PR Newswire
published: June 12, 2014 in: Boston Scientific, Clinical Studies/Trials, Neuro