FDA clears Emerge Balloon Dilatation Catheter


The US Food and Drug Administration (FDA) has given clearance to Boston Scientific for its Emerge Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter. The company has begun marketing the device in the United States.  

The Emerge Catheter is a next-generation pre-dilatation balloon catheter designed to treat challenging lesions in coronary arteries. It is available in monorail and over-the-wire. The Emerge Catheter has been commercially available in CE mark countries since earlier 2012.

“The Emerge Balloon Catheter combines Boston Scientific’s innovative balloon technologies into a single platform,” said J Tift Mann, III, Wake Heart & Vascular, Raleigh, North Carolina, USA. “The result is exceptional deliverability and reliable performance in a wide range of anatomy and lesion types.”

The Emerge Balloon Catheter is available in diameters from 1.5mm up to 4.0mm, with balloon lengths ranging from 8mm up to 30mm. 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” (1.5mm) offers a single-segment inner shaft for enhanced pushability. The “Workhorse Technology” (1.5mm to 4.0mm) features a bi-segment inner shaft designed for excellent deliverability without sacrificing push.