Boston Scientific's stent keeps clogged arteries open in recent study

By Angela McDaniels

Seattle, Jan. 23 - Boston Scientific Corp. said that in a recent study, only 21.3% of renal artery disease patients experienced re-narrowing of the arteries nine months after being treated with the company's Express SD Renal stent.

The single-arm, multi-center study involve 100 patients in 14 U.S. sites. The primary endpoint of the study was restenosis, or the re-narrowing of a previously stented vessel.

Boston Scientific said it compared the restenosis rate to a benchmark of 40%, which was determined by a literature review of similar endpoints in patients undergoing balloon angioplasty of the renal artery.

"These results will be used by Boston Scientific to seek approval from the Food and Drug Administration to make the Express SD Renal stent available for use in the renal arteries," John Pedersen, president of Boston Scientific's Peripheral Interventionsla business, said in a company news release.

"It will be the first low-profile stent specifically approved for use in the renal arteries, which should allow physicians to deliver the stent in more complex cases."

Trial results also reported what the company called excellent safety results and an 8.4% rate of target lesion revascularization - repeat procedures due to re-narrowing of the vessel.

Results were represented by lead investigator Krishna Rocha-Singh of Prairie Cardiovascular Heart Institute in Springfield, Ill., at the International Symposium on Endovascular Therapy in Miami Beach.

Renal artery disease is a narrowing of the blood supply to the kidneys due to the formation of plaque within the arteries. It can be treated surgically or via angioplasty, during which a balloon is inserted into the artery and then inflated, compressing the plaque against the walls of the artery, and then removed.

Re-narrowing of the arteries is common with this treatment method, the company said. A stent instead remains in the artery after the removal of the balloon.

Boston Scientific is a Natick, Mass., maker of medical devices.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.