UPDATED June 12, 2014, with results from an additional trial.
The medical device company said a 15-patient study of the Vercise device showed that shorter pulses may be better in treating Parkinson’s than conventional, wider pulses. And 1-year data from a 2nd, 40-patient study showed a "highly significant and consistent" improvement in motor scores, Boston Scientific said.
Results from the Custom-DBS trial, presented at the International Congress of Parkinson’s Disease & Movement Disorders in Stockholm by primary principal investigator Dr. Jens Volkmann, showed that the shorter pulse widths expands the available range of current to provide therapy without side effects, according to a press release.
"The results are truly exciting because the key to optimal DBS treatment is first to get accurate targeting and then find an electrode with a large therapeutic window, where a patient is getting the best management of PD symptoms with minimal side effects," Volkmann said in prepared remarks. "The shorter pulse width settings with the Vercise System required less electrical energy to achieve optimal therapy, suggesting there may also be energy efficiency advantages to these settings as well."
The trial, a randomized, multi-center, double-blind study, making the trial "1 of the first studies to provide Level I evidence of a clinical advantage to specific deep brain stimulation settings, such as shorter pulse widths," according to the release. Boston Scientific claims the Vercise device as the only commercially available platform that can generate the shorter pulse widths.
"The Custom-DBS study distinguishes the Vercise DBS System from other technologies by its ability to provide better outcomes for patients with this new stimulation approach," neuromodulation president Maulik Nanavaty said in a statement. "Our clinical program demonstrates Boston Scientific’s commitment to advancing therapy for patients through clinical evidence that demonstrates meaningful innovation and compelling results."
Results from Boston Scientific’s Vantage trial, also presented at the Parkinson’s & Movement Disorders conference, showed a 62% improvement in motor function at 12 months, the company said.
"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," neurological principal investigator Dr. Lars Timmermann, who presented the data, said in prepared remarks. "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," Nanavaty added. "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."
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