UPDATE 3-US FDA approves Boston Scientific's drug-coated heart device
(Adds shares in paragraph 2)
March 1 (Reuters) - Boston Scientific said on Friday the U.S. FDA had approved its drug-coated device to treat a complication arising from implanting a stent in the heart.
Shares of the medical device maker rose 1.5% in afternoon trading.
The approval makes the device, branded Agent, the first drug-coated balloon catheter in the U.S. to treat coronary in-stent restenosis (ISR) in patients with a type of heart disease. ISR involves accumulation of plaque or scar tissue under the stent, causing a previously opened heart vessel to narrow again.
"We view Agent highly favorably for its statistically significant superiority in what is a difficult-to-treat and common ISR patient population, which we think could enable rapid physician adoption," BTIG analyst Marie Thibault said in a note.
The global ISR market is worth around $500 million, according to Thibault.
Boston Scientific's device, which it plans to launch in the coming months, is a balloon catheter coated with a drug called paclitaxel and is designed to transfer the drug to the vessel wall to help prevent ISR reoccurrence.
Currently, patients with ISR have to undergo treatments such as additional layers of stenting or radiation.
Approval for the device was based on data from 480 patients from a study in which the drug-coated device significantly reduced rates of certain complications 12 months after receiving treatment, compared with an uncoated device. (Reporting by Mariam Sunny in Bengaluru; Editing by Shinjini Ganguli and Devika Syamnath)
