Boston Scientific Corp. (BSX:US) won’t begin a study of its hypertension treatment until it can analyze a failed effort by Medtronic Inc. (MDT:US) and review its approach with U.S. regulators, Chief Executive Officer Michael Mahoney said.
While Boston Scientific has Food and Drug Administration backing to start a pivotal trial of its Vessix technology, the company is waiting to see whether the failure of Medtronic’s product in a study last week stemmed from the device or the clinical trial design, or whether the entire approach is invalid.
The results of the study may shed light on patient safety and effectiveness of the approach called renal denervation, which lowers blood pressure by damaging the nerves that help fuel it, Mahoney said. Trials demanded by U.S. regulators to approve innovative devices are complex and costly, and the Natick, Massachusetts-based device maker wants to make sure it is done correctly, he said. The study was expected to start by July, though the timing is no longer clear, he said.
“We want to wait and see and learn more about the Medtronic trial results before we have broad discussion with the FDA about what the trial design should be,” Mahoney said in an interview at the JPMorgan Chase & Co. health-care conference in San Francisco. “We want to consider the facts of that miss. We would be crazy not to take a pause and learn about the findings of that trial and adjust our plans accordingly.”
Boston Scientific’s Vessix already is available in Europe, and analysts expect it to help drive the device maker back to growth after posting losses (BSX:US) for six of the past seven years. The company has expanded its range of products during the past three years to ease a dependence on sluggish demand and crimped prices for devices to regulate heart rhythm and stents to prop open clogged arteries.
“The good news is that our pipeline and our portfolio are much more diversified than in the past,” Chief Financial Officer Daniel Brennan said in an interview. “As you look at it, some products will do better, some will do not as well. We’re not reliant on that one product that has to do well or we won’t grow.’
The Watchman device to close the left atrial appendage in the heart, an extraneous area where blood clots form and can lead to strokes, is expected to get approval by the second quarter, Mahoney said. No competitors are close to the market, which he said may grow to $500 million a year.
Boston Scientific is back on the market with its S-ICD defibrillator, which can restore electrical activity in the heart without connecting wires directly to it. The wires, called leads, have failed in traditional defibrillators, raising safety questions. The company essentially stopped selling (BSX:US) the S-ICD in the second and third quarter because of manufacturing problems.
Sales resumed at the end of the fourth quarter, Mahoney said. The market, with no rivals on the horizon, will increase to about $750 million by 2017, he said.
Boston Scientific gained 1.6 percent to $13.55 at the close in New York. The company has more than doubled (BSX:US) since Dec. 16, 2011 when it hit a low of $5.14.
Since July 2011, Boston Scientific has repurchased 14 percent of its shares outstanding.
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