Boston Scientific (NYSE:BSX) CEO Mike Mahoney told an audience at the J.P. Morgan Healthcare conference today that the medtech maker is still bullish about the prospects for its Vessix renal denervation platform for treating high blood pressure, despite the surprising news last week that Medtronic‘s (NYSE:MDT) U.S. trial failed to meet its efficacy endpoint.
Mahoney stressed that the Vessix platform, which Boston Scientific acquired for $425 million last October, is a generation removed from Medtronic’s Symplicity device, which met its safety goal but failed to prove effective in the Symplicity HTN-3 trial.
Medtronic’s highly anticipated SYMPLICITY HTN-3 clinical trial, the 1st of its kind to analyze renal denervation in a blinded, sham-controlled manner, failed to meet endpoints for efficacy in treating patients with drug-resistant hypertension. Yesterday Medtronic CEO Omar Ishrak told MassDevice.com that more analysis of the data is on tap before a decision is made on renal denervation for resistant hypertension.
Mahoney hewed to a similar line.
"It’s important to know that Vessix is a 2nd-generation, balloon-expandable, multi-point renal denervation platform. We also believe that Vessix is highly differentiated from a competitor’s product that recently announced missing its efficacy endpoint in a U.S. trial," he said today in San Francisco. "We are excited about the Vessix platform, potentially still in hypertension, but also perhaps in other diseases. We continue to evaluate other segments where we could take that Vessix platform. We think we acquired it at a very good price and it’s a great capability. The clinical data that we have in Europe are very good. We think there are a number of differentiated features with our Vessix platform versus the competitor who failed on their efficacy trial – the fact that it’s a balloon-expandable device, it has a multi-point capability where the electrodes will turn on and turn off if they’re out of position. So we think there are ease-of-use benefits, there’s clearly a speed benefit, so we think it’s a better platform."
Echoing comments made here yesterday by Daniel Starks, CEO of arch-rival St. Jude Medical (NYSE:STJ), the 3rd major player in the renal denervation space, Mahoney cautioned that it’s too early to make any decisions based on the outcome of the Symplicity trial.
"The data’s been very good, but the news that came out a week or so ago was a surprise to the industry, so we’re going to make sure we take our time and really evaluate the clinical results of that trial and use that information as a basis for our next steps, to determine what the best clinical strategy is," he noted. "We’re ready to take [Vessix] to trial in the U.S. – we want to learn from that [Symplicity] data and design the trial in a proper way, based on the information that comes out of that [Symplicity trial]."
Dr. Keith Dawkins, Boston Scientific’s chief medical officer, said the company has 12-month data for Vessix compiled from both 24-hour ambulatory blood pressure readings and from measurements taken in doctors’ offices.
"It’s important to re-emphasize that we’re very positive about this space. We have good data with Vessix, now out to 12 months, and that’s both ambulatory – 24-hour – blood pressure and office blood pressure," Dawkins said. "We have an agreed protocol with the FDA now and we will, if necessary, make changes to that protocol as the results from the Symplicity trial come in."
"I think we’re just in the very early stages of figuring out how to best help patients with a renal denervation procedure, but there’s nothing in [Medtronic’s] announcement that dissuades us from continuing to pursue this," he said. "This was unexpected for us, to have a negative result from Medtronic’s trial, and it’s too soon for us to know what to make of that," Starks said. "It really raises far more questions than it provided answers."