Boston Scientific Announces Approval and Launch of OptiCross Coronary Imaging Catheter

July 24, 2013—Boston Scientific Corporation (Natick, MA) announced the regulatory approval and market launch of the OptiCross coronary imaging catheter in the United States, Europe, and Japan.

The OptiCross has received US Food and Drug Administration clearance in the United States, CE Mark approval in Europe, and approval from the Pharmaceuticals and Medical Devices Agency in Japan. The device has been launched in the United States and Europe. A launch in Japan is planned for late July.

According to Boston Scientific, OptiCross is a next-generation intravascular ultrasound (IVUS) catheter that provides improved deliverability and higher-resolution imaging to facilitate complex coronary procedures. The OptiCross is designed to be compatible with the Boston Scientific iLab ultrasound imaging system, The upgraded low-profile delivery system features 5-F guide catheter compatibility; a shorter, tapered tip; a bisegmented catheter shaft; and a redesigned catheter hub for ease of connection.

Matthew Price, MD, and Neal Uren, MD, commented on the OptiCross in the company's press release. Dr. Price is Director of the Cardiac Catheterization Laboratory at Scripps Green Hospital in San Diego. Dr. Uren is Clinical Director for Cardiac Services at the Edinburgh Heart Centre at the Royal Infirmary Edinburgh in Scotland, United Kingdom.

“The OptiCross catheter was designed for optimal deliverability and its performance proves it. Now I can use IVUS technology in complex cases where I would not have been able to deliver an IVUS catheter before,” stated Dr. Price.

Dr. Uren added, “The OptiCross catheter widens the applicability of ultrasound with the ability to assess disease preprocedure, without concern regarding ischemia and lesion trauma. The incremental increase in deliverability widens the use of IVUS into more difficult lesion subsets while maintaining superior image quality.”