TORONTO, Jan. 14, 2016 /PRNewswire/ - Conavi Medical Inc. (formerly Colibri Technologies Inc.) has received United States (US) Food and Drug Administration (FDA) 510(k) clearance for the Foresight ICE System for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy as well as visualization of other devices in the heart and great vessels of patients.
The Foresight ICE System is the first catheter-based ultrasound system capable of providing both 2D and 3D ultrasound images of cardiac anatomy around the circumference of the catheter's tip. The system includes the dual display Conavi Hummingbird imaging console and the Foresight ICE catheter. These products can be used to support a growing number of minimally invasive cardiovascular procedures performed in the US, such as ablations and other procedures that may require access to targeted regions of the heart.
"FDA clearance of the Foresight ICE System represents a major milestone for Conavi's team and our customers in the US healthcare system," says Brian Courtney, CEO of Conavi Medical Inc. "We look forward to working with physicians in the United States by providing them with new visualization tools to support existing and emerging minimally invasive procedures for patients with a broad range of cardiac conditions. The Foresight ICE system represents Conavi's lead product in its commercialization pipeline. The advanced technology in this system provides us with a remarkable platform from which we will be able to expand in the future to help physicians, healthcare systems and industry partners better address a large number of clinical needs."
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