July 29, 2013 — The Boston Scientific Corporation has received U.S. Food and Drug Administration (FDA) clearance, CE mark and Japan PMDA approval for its OptiCross Coronary Imaging Catheter and has launched the device in the United States and Europe. A launch in Japan is planned for later this month. OptiCross, a next generation intravascular ultrasound (IVUS) catheter, offers better deliverability and higher resolution imaging to facilitate complex coronary procedures.
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.
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.
For more information: www.bostonscientific.com