The Boston Scientific Corporation has received US Food and Drug Administration clearance, CE Mark and Japan PMDA approval for its OptiCross Coronary Imaging Catheter and has launched the device in the US and Europe. OptiCross, a next generation intravascular ultrasound (IVUS) catheter, offers better deliverability and higher resolution imaging to facilitate complex coronary procedures.

The device is planned to launch later this month in Japan.

It is designed to be compatible with the Boston Scientific iLab Ultrasound Imaging System, the OptiCross catheter was created with the input of physicians from around the world to reduce the inherent challenges surrounding catheter delivery in complex cases. The upgraded, low profile delivery system features 5 French guide catheter compatibility, a shorter, tapered tip, a bi-segmented catheter shaft and a redesigned catheter hub for ease of connection.

"The OptiCross catheter was designed for optimal deliverability and its performance proves it," said Matthew Price, MD, interventional cardiologist and director of the Cardiac Catheterization Laboratory, Scripps Green Hospital, San Diego. "Now I can use IVUS technology in complex cases where I would not have been able to deliver an IVUS catheter before."

Interventional cardiologists use IVUS to see inside coronary arteries and to gain additional information in order to optimize treatment decisions.

"The OptiCross catheter widens the applicability of ultrasound with the ability to assess disease pre-procedure, without concern regarding ischemia and lesion trauma," said Dr Neal Uren, clinical director for cardiac services at the Edinburgh Heart Centre, Royal Infirmary, Edinburgh. "The incremental increase in deliverability widens the use of IVUS into more difficult lesion subsets, while maintaining superior image quality."

The benefits of IVUS-guided percutaneous coronary intervention (PCI) were reinforced at TCT 2012 and at EuroPCR in May with the presentation of the ADAPT-DES IVUS sub-study outcomes. The results showed that IVUS can help improve patient outcomes and change the way physicians approach their cases.

"The OptiCross catheter demonstrates Boston Scientific's commitment to advancing intravascular imaging technology and represents the first of a series of related innovations that we expect to launch in the next 18 months," said Isaac Zacharias, vice president and general manager, Imaging, Boston Scientific. "An increase in complex PCIs, coupled with a growing focus on data-driven improvements in outcomes, show that IVUS technology should play a more important role."

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