The FDA is evaluating reports about a rare but serious problem--known as longitudinal stent deformation--associated with Boston Scientific's ($BSX) Promus Element heart stents and is requiring the company to caution doctors about it.
Boston Sci isn't the only company facing this problem, as Reuters notes. Rivals Medtronic ($MDT) and Abbott Labs ($ABT) have also seen this problem, but it seems to happen most with Boston Sci's offering.
Promus Element features very thin struts that make the device more flexible and help physicians to implant it in narrow or difficult-to-reach vessels. But this attribute could make the product more vulnerable to becoming stretched or compressed while being placed.
"Stents have a lot of different properties, which vary from one to another," Gregg Stone, director of cardiovascular research at New York Presbyterian Hospital/Columbia University Medical Center, said in a conference call, as quoted by Bloomberg. "Some stents will be more prone to this complication than others. The question is to understand how frequent it is, when does it occur, how to prevent it and how to manage it."
As Reuters notes, any problems with the Promus Element could spell trouble for Boston Sci, as the device is the basis for future generations of heart stents. There were 136 longitudinal stent deformation events per 829,372 units sold worldwide as of Oct. 31, Boston Sci said.
The FDA gave its blessing to the Promus Element system last month. At the time, the company said the transition to the Promus Element showed its commitment to shifting to internally manufactured everolimus-eluting stents in the U.S.
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