Boston Scientific (NYSE:BSX) is delayed the timeline for a clinical trial of its Spectra WaveWriter spinal cord stimulation device by nine months, chief medical officer Dr. Ian Meredith said yesterday, hard on the heels of a court decision involving SCS rival Nevro Corp. (NYSE:NVRO).
Judge Vince Chhabria of the U.S. District Court for Northern California, who ruled earlier this month that any claims in the patents describing a non-paresthesia-producing therapy effect are indefinite, decided this week that six claims in three of the Nevro patents are eligible, but also ruled that Boston’s spinal cord stimulation devices do not infringe those claims (Boston doesn’t have a competing high-frequency SCS device on the U.S. market).
Nevro claimed that the decision “would effectively preclude Boston Scientific from commercially providing high frequency SCS therapy between 1.5 kHz and 100 kHz in the United States.” Asked about that during a conference call discussing Boston’s second-quarter results yesterday, Meredith said that frequency is only one of several factors that affect SCS therapy.
“The primary goal of the Accelerate trial is to look at the impact of frequency on pain relief, where we now know that frequency is only one element. The pulse amplitude and other factors are also very important, and you know that we have both the Whisper and Proco studies, which have basically demonstrated that choosing between frequencies results in better outcomes. That’s the Whisper study, and the Proco study was within subject comparison of multiple frequencies, showing that you could in fact actually get as good pain relief with 1,000 hertz versus 10,000 hertz and using significantly less energy and battery life to do that. So I think we’re changing our view on what spinal cord stimulation patterns and frequencies need to be to cover both amplitude and waveform,” Meredith said, according to a Seeking Alpha transcript.
Meredith said the company shifted the estimated primary completion date for the Accelerate study from July 2018 to March 2019, meaning final results would be out between April and November next year.
“This nine-month delay ensures that we can collect sufficient data on the Spectra WaveWriter system,” he said.