Boston Scientific Corp on Friday said the US Food and Drug Administration is looking into reports of one death and six injuries linked to the use of its treatment for acid-reflux disease.
The review comes on the heels of a major recall in recent weeks of its popular Taxus device to treat clogged heart arteries after that device was linked to several deaths and injuries.
Boston Scientific, whose shares were down nearly 2 percent on Friday, said the FDA is looking into its Enteryx device, an injectable treatment for acid reflux, after the death of an elderly woman last month, three weeks after treatment.
The agency will try to determine whether the death was linked to the device or to physician technique.
"We've reported this to the FDA and we're working co-operatively with them," said Paul Donovan, a Boston Scientific spokesman.
The Enteryx treatment - which the company had identified as one of its top products in terms of sales growth potential - involves the injection of a plastic substance into the esophagus to help protect patients from acid backing up from the stomach.
Late last month, the company issued an alert to doctors about the product and is updating the product label.
In the case of the patient who died, some of the polymer had been injected into the woman's aorta, which ruptured, causing her to bleed to death.
Glenn Novarro, an analyst with Banc of America Securities, characterised the latest FDA probe as a "nonevent."
"While certainly this negative headline comes at an inopportune time with the company dealing with Taxus-related concerns from the FDA, the Enteryx issue is not manufacturing-related and investors should not be concerned that this has broader implications for the company," Novarro wrote in a research note.
Shares of Boston Scientific were down 51 cents or 1.5 percent at $32.78 on the New York Stock Exchange on Friday morning, off an earlier low at $32.53.
They have shed almost a quarter of their value since July 1, the day before the company announced for the first time its recall of its coronary stent system, Taxus.
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