Boston Scientific Next-Gen Stent Gets FDA Approval

Boston Scientific (NYSE:BSX) has gotten the nod from the U.S. Food and Drug Administration for its Promus Element Plus cardiac stent, which is designed to more easily deliver the stent to the artery and increase performance when clearing the blockage.

The next-generation stent, which is intended to treat patients with coronary artery disease, is built specifically for coronary stenting, which enables thinner struts and enhanced visibility.

Boston Scientific, which plans to begin marketing the product in the U.S. immediately, said its design offers a more conformable stent with less recoil and higher radial strength, as well as a low-profile delivery system to help facilitate its delivery across challenging lesions.

The approval, which came earlier than expected, marks a milestone for Boston Scientific. The company will replace the new stent with an older one it markets with Abbott Laboratories (NYSE:ABT), from which Abbott receives 40% of the profit.

Boston plans to receive regulatory approval for Promus Element by mid-2012 in Japan, which should contribute an additional $200 million to Boston Scientific’s gross margin after 2012, the company said.