Boston Scientific's Emerge PTCA Dilatation Catheter Approved in Europe

April 24, 2012—Boston Scientific Corporation (Natick, MA) announced that it has received CE Mark approval for the Emerge percutaneous transluminal coronary angioplasty (PTCA) dilatation catheter. The company will launch the Emerge predilation balloon catheter immediately in Europe and other CE Mark countries with both Boston Scientific's Monorail and over-the-wire (OTW) options.

According to Boston Scientific, the Emerge PTCA dilatation 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 atm) for sizing flexibility. The Emerge catheter platform offers a reduced, low-friction shaft profile that allows for simultaneous use of two Monorail balloon catheters in a 6-F guide catheter and two OTW balloon catheters in an 8-F guide catheter.

“The Emerge catheter combines several innovative balloon technologies in a single versatile platform,” commented Jean Fajadet, MD, who performed the first procedure in Europe with the device. “The result is a functional catheter with a low profile and excellent deliverability to facilitate the navigation and crossing of challenging coronary lesions.”

The Emerge catheter is available in balloon diameters of 1.2 to 4 mm and balloon lengths of 8 to 30 mm. Both the Monorail and OTW catheters are available in a “push technology” (1.2 and 1.5 mm) for a single-segment inner shaft for enhanced pushability, and a “workhorse technology” (1.2 to 4 mm) option, which features a bisegment inner shaft.

The company advised that commercial availability for the device is expected in the United States and additional international markets later this year. The Emerge 1.2-mm and 1.5-mm PTCA dilatation catheters are currently under review by the US Food and Drug Administration, and are not available for sale in the United States.