Boston Scientific (NYSE:BSX) won FDA 510(k) clearance for its next-generation Emerge percutaneous transluminal coronary angioplasty balloon dilation catheters in treatment of coronary artery disease, the leading cause of death in the U.S.

The Emerge PTCA balloon dilation catheters, used during angioplasty and stenting procedures, help open clogged arteries that, left untreated, could lead to heart attack.

The company has already begun marketing the device, offering both Monorail and Over-The-Wire balloon catheter options, according to a press release.

The Natick, Mass.-based medtech titan earlier this year won CE Mark approval in the European Union for the Emerge PTCA line and began commercialization right away. The catheters are also available in a range of sizes from 1.2mm up to 4mm, with balloon lengths ranging from 8mm up to 30mm, according to a statement.

"The Emerge Balloon Catheter combines Boston Scientific’s innovative balloon technologies into a single platform," North Carolina cardiologist Dr. J. Tift Mann, III, said on behalf of the company. "The result is exceptional deliverability and reliable performance in a wide range of anatomy and lesion types."

It’s the 2nd win this week for Boston Scientific, which also announced approvals to launch its next-generation Reliance 4-Front defibrillator leads in Europe and Asia.

BSX shares saw slight gains on Wall Street today, trading 0.9% higher at $5.66 as of about 12:35 p.m.