Cardiac Ultrasound Catheter Cleared by FDA

An intravascular ultrasound (IVUS) imaging catheter incorporating Monorail catheter technology has been cleared by the U.S. Food and Drug Administration (FDA). The catheter, called Atlantis SR, has also received the CE Mark and has been approved by the Japanese Ministry of Health and Welfare.

The product of Boston Scientific (Natick, MA, USA), Atlantis SR will be marketed by Boston's cardiology division, Boston/Scimed. It is the only commercially available 40 MHz IVUS catheter compatible with 6 French guiding catheters, says the company. The 40 MHz transducer offers the highest frequencies available, allowing for high-resolution images that are easy for doctors to interpret. Six French compatibility is a significant feature because the downsizing of stents and other devices has caused 6 French guiding catheters to be more commonly used in interventional procedures. In addition, the company notes that the distance between the transducer and the tip of the Atlantis has been reduced for more distal imaging.

As a diagnostic tool, the Atlantis SR catheter aids in determining the most appropriate course of intervention for coronary disease, such as when it is used to help determine stent size selection or to assess the expansion of coronary stents, said Paul Buckman, president of Boston Scientific/Scimed.