FDA Clears Boston Scientific's Emerge PTCA Balloon Dilatation Catheter

September 27, 2012—Boston Scientific Corporation (Natick, MA) announced that it has received US Food and Drug Administration clearance for its Emerge percutaneous transluminal coronary angioplasty (PTCA) balloon dilatation catheter and has begun marketing the device in the United States. The Emerge catheter has been commercially available in CE Mark countries since earlier this year.

The company stated in its press release that the Emerge device is a next-generation predilatation balloon catheter that is designed to treat challenging lesions in the coronary arteries. It is available in an array of balloon diameters from 1.5 to 4 mm and balloon lengths of 8 to 30 mm. The Emerge device is available in monorail and over-the-wire platform options.

Both the monorail and over-the-wire catheters are available with two distinct shaft technologies designed to provide versatility in addressing different clinical situations. The “Push Technology” (1.5 mm) offers a single-segment inner shaft for enhanced pushability. The “Workhorse Technology” (1.5–4 mm) features a bisegment inner shaft designed for excellent deliverability without sacrificing push, according to Boston Scientific.

J. Tift Mann, III, MD, at Wake Heart & Vascular in Raleigh, North Carolina, commented on the new device in the company's press release. Dr. Mann said, “The Emerge balloon catheter combines Boston Scientific's innovative balloon technologies into a single platform. The result is exceptional deliverability and reliable performance in a wide range of anatomy and lesion types.”