Conavi Medical Inc. (www.conavi.com) is pleased to announce 510(k) clearance from the FDA for its Foresight ICE System expanded feature set. The enhancements include color doppler, pulsed wave doppler, 2D and 3D measurements, and ECG-gated 3D image acquisition. These enhancements are expected to help electrophysiologists and interventional cardiologists in the US by providing them with the tools to make decisions during minimally invasive cardiovascular procedures.
“This system is the world’s first intracardiac echo system with the capability to acquire 2D and 3D images with a broad field-of-view that includes both side-viewing and forward-looking capabilities. We have now expanded upon this foundation by adding image quality enhancements, features to minimize the effects of cardiac motion and the inclusion of additional imaging modes.” says Dr. Brian Courtney, CEO of Conavi Medical.
The system’s indication for use has been expanded to include the ability to assess physiology with its new doppler capabilities. Dr. Courtney continues, “The addition of doppler imaging and flow quantification greatly expands the range of clinical scenarios in which Conavi’s Foresight ICE System can be used. As a result, we are the only provider of rotational ICE that provides doppler capabilities, and thus benefit from being able to target regions of the cardiac anatomy anywhere around the 360-degree field-of-view of our catheter. The achievement of this 510(k) clearance demonstrates Conavi’s commitment to being a highly responsive source of imaging technologies to physicians performing electrophysiology procedures, structural heart interventions and other cardiovascular procedures that stand to benefit from image guidance.”
The Foresight ICE System is available for electrophysiologists and interventional cardiologists practicing in the US who are seeking to use advanced technology for their intracardiac procedures.