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Boston Scientific CEO Michael Mahoney said that the company will not begin a pivotal US study of its Vessix renal denervation system as a treatment for hypertension until it can analyse trial results for Medtronic's similar device and review its approach with the FDA, Bloomberg reported. "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 commented.
Earlier this month, Medtronic announced that its Symplicity renal denervation system did not meet the primary efficacy endpoint of a pivotal US trial for treatment-resistant hypertension. As a result, Medtronic said that it will review the future of its global hypertension clinical trial programme for the system, as well as any impact on access to the device in countries where it is approved. Experts also suggested that the outcome of the trial could hamper the efforts of other companies developing similar technology.
"We would be crazy not to take a pause and learn about the findings of that trial and adjust our plans accordingly," agreed Mahoney. The CEO indicated that because of the complexity and cost of the FDA-required studies, the company wants to be certain that its trial is conducted correctly. Mahoney added that the start date of the study, which was scheduled for July, is currently unclear.
Boston Scientific obtained the Vessix technology as part of its acquisition of Vessix Vascular for as much as $425 million in November 2012. The denervation system was approved by European regulators earlier that year.
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