March 19, 2019

Boston Scientific artery device caught up in FDA review

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Boston Scientific is headquartered in Marlborough.

The U.S. Food & Drug Administration is conducting a review of balloons and stents using a common chemotherapy drug after a trial found the devices, including one made by Boston Scientific, could actually be harmful.

In January, the FDA wrote healthcare providers about a recent meta-analysis of randomized trial published in December in the Journal of the American Heart Association (JAHA) suggesting a possible increased mortality rate after two years in patients with peripheral arterial disease who used a paclitaxel-coated balloon or paclitaxel-eluting stent.

Boston Scientific was one of 11 companies mentioned in that analysis.

Those devices work to open the obstructed artery in the legs, and paclitaxel is released to prevent scar tissue from forming in the blood vessel.

On Friday, FDA said it is convening an advisory committee to review the results of that randomized trial. The agency recommended doctors continue monitoring patients who have been treated with the devices.

The JAHA analysis mentioned Boston Scientific's Ranger drug-coated balloon, but the company has at least one other paclitaxel device, the Eluvia DES.

In a statement, Marlborough-based Boston Scientific said patient safety is the company's highest priority. The company said it welcomed a review of the risks, benefits and clinical data of the technology.

The company said it remains confident in the benefits and safety of such devices it markets and its clinical trials have not found evidence of an increased mortality rate.

Further, the Eluvia and Ranger were developed with the lowest possible dose of paclitaxel, the company said.

The Eluvia device was cleared by the FDA in September.

"We are committed to data transparency and will continue to provide the FDA with all requested data to ensure the agency can facilitate a thoughtful discussion about the value of these therapies and the clinical research that supports them," the company said.


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