Boston Scientific resumes sales of cardiac defibrillators
Boston Scientific has resumed U.S. distribution of two models of cardiac defibrillators that account for virtually all of its domestic defibrillator sales.
The company pulled the heart rhythm management products from the market in March, after disclosing it had failed to seek agency approval for two manufacturing changes.
The Food and Drug Administration then conducted a 30-day review of documents Boston Scientific filed and cleared the changes in a decision on Thursday.
Tim Nelson, a senior health care analyst at FAF Advisors, said the FDA handled the issue faster than he expected. He said that helps reinforce Boston Scientific's message that it was just dealing with a paperwork snafu, and it reflects well on management's seriousness about safety.
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"They moved expeditiously and conservatively," Nelson said. "They probably didn't need to do the drastic actions they did in terms of pulling all their products off the market and stopping their sale, but they did it anyway."
Nelson estimates Boston Scientific lost between $110 and $150 million in sales due to the issue and possibly 3-4 percent of its market share, but it will be hard to assess the exact damage, given other factors.
"The competitors have much stronger new product flows than Boston Scientific does, and Boston Scientific is also running out of steam with their replacement business," he said.
Nelson said a big chunk of Boston Scientific's sales came from replacing products whose batteries had worn out, but that's tapering off.