The Natick, Mass.-based med-tech titan won EU regulatory approval to market the Emerge system, its next-generation pre-dilation balloon catheter designed to help physicians cross difficult lesions in the heart, according to a press release.
"The Emerge catheter combines several innovative balloon technologies in a single versatile platform," Dr. Jean Fajadet of Clinique Pasteur in France, who performed the 1st European procedure with the Emerge device, said in prepared remarks. "The result is a functional catheter with a low profile and excellent deliverability to facilitate the navigation and crossing of challenging coronary lesions."
Boston Scientific intends to launch immediately in European countries, offering both Monorail and Over-The-Wire balloon catheter options.
The catheters are also available in a range of sizes from 1.2mm up to 4mm, with balloon lengths ranging from 8mm up to 30mm, according to a statement.
The 1.2mm and 1.5mm Emerge catheters are currently under FDA review, and Boston Scientific expects U.S. market approval later this year, according to a press release.
BSX shares gained a little back this morning, rising 1.2% to $5.93 as of about 9:45 a.m.
The company slid on Wall Street yesterday on warnings of electrical malfunctions in its Cognis and Teligen implantable cardioverter defibrillators after receiving reports of a small number of adverse events including 1 patient’s death.
BSX shares closed 1.5% lower to $5.85 last night from an opening price of $5.95.