Boston Scientific Launches Balloon Catheter in Europe

Natick, Mass.-based Boston Scientific has received CE Mark approval to market the Emerge PTCA dilation catheter. The product is to be launched in Europe immediately. Emerge is a pre-dilation balloon catheter designed to address challenging coronary artery lesions.

The catheter will be released in CE Mark countries in both monorail and over-the-wire (OTW) options. A monorail balloon catheter works by the guide wire passing through the balloon and running through the guiding catheter, while an over-the-wire balloon catheter has two lumens: one for the guide wire and the other for balloon inflation. In over-the-wire, the guide wire exists independent of the balloon so two operators must perform the coronary procedure, while the monorail application only requires one operator.

The catheter includes a 1.2 mm diameter balloon option that features an ultra-low 0.017 inch tip profile and low crossing profiles designed to cross tight lesions. The Emerge 1.2 mm balloon also employs a durable balloon material that provides high rated burst pressure (18 asynchronous transfer mode, or ATM) for sizing flexibility. According to the company, the Emerge system offers a reduced, low-friction shaft profile that allows for simultaneous use of two monorail balloon catheters in a 6F guide catheter and two OTW balloon catheters in an 8F guide catheter.

The Emerge Catheter is available in different diameters from 1.2 mm to 4.0 mm, with balloon lengths ranging from 8 mm up to 30 mm. Both the monorail and OTW catheters are available with two distinct shaft technologies designed to provide versatility in addressing different clinical situations. The “Push Technology” (1.2 mm and 1.5 mm) offers a single-segment inner shaft for enhanced pushability. The “Workhorse Technology” (1.2 mm to 4.0 mm) features a bi-segment inner shaft designed for improved deliverability without sacrificing push.

The first physician to use the device is Jean Fajadet, M.D., of Clinique Pasteur in Toulouse, France. He praised the catheter for its “innovative features and broad range of available options,” which “enables physicians to select the appropriate catheter based on clinical need, helping to improve outcomes for patients undergoing coronary interventions.”

The Emerge catheter is currently under review by the U.S. Food and Drug Administration, and is not available in the United States.