CE Mark For Boston’s Low Profile Emerge™ PTCA Catheter

In short

Boston Scientific Corporation has announced CE Mark and immediate European market launch of the Emerge PTCA Dilatation Catheter. The company describes its Emerge Catheter as a next-generation pre-dilatation balloon catheter designed specifically to offer exceptional deliverability to address challenging lesions.

Background

Coronary artery disease represents the leading cause of death in the United States and Europe, reportedly accounting for more than 870,000 U.S. deaths each year and 1.95 million deaths annually in Europe. PTCA dilatation catheters are used in coronary angioplasty and stenting procedures to open arteries blocked by atherosclerosis, which if left untreated can cause heart attack and stroke.

The Emerge PTCA Dilatation Catheter’s distinguishing feature is its ability to cross tight lesions. It includes a 1.2 mm diameter balloon option that features an ultra-low 0.017″ tip profile and low crossing profiles to this end. According to Boston Scientific, the Emerge 1.2 mm balloon also employs a durable balloon material that provides high rated burst pressure (18 ATM) for sizing flexibility. The Catheter platform offers a reduced, low-friction shaft profile which 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 company plans to launch the product in CE Mark countries in both Monorail® and Over-The-Wire (OTW) options. Commercial availability is expected in the U.S. and additional international markets later this year.

The Emerge Catheter is available in a wide array of balloon diameters from 1.2 mm up 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 excellent deliverability without sacrificing push.

Clinician comments

“The Emerge Catheter combines several innovative balloon technologies in a single versatile platform,” said Jean Fajadet, M.D., Clinique Pasteur, Toulouse, France, who performed the first procedure in Europe with the Emerge PTCA Dilatation Catheter. “The result is a functional catheter with a low profile and excellent deliverability to facilitate the navigation and crossing of challenging coronary lesions.”

Company comments

“The Emerge Catheter builds on Boston Scientific’s expertise in developing leading catheter technology and our commitment to offering the most advanced devices to treat coronary artery disease,” said Kevin Ballinger, president of Boston Scientific’s cardiovascular division. “The innovative features and broad range of available options for the Emerge platform enables physicians to select the appropriate catheter based on clinical need, helping to improve outcomes for patients undergoing coronary interventions.”

Availability

The Emerge 1.2 mm and 1.5 mm PTCA Dilatation Catheters are currently under review by the U.S. Food and Drug Administration, and are not available for sale in the United States.

Source: Boston Scientific Inc., PR Newswire