Conavi Medical Announces FDA 510(k) Clearance of the Novasight Hybrid System with Simultaneous Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) Capabilities

TORONTO - ConaviTM Medical Inc. is pleased to announce that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its NovasightTM Hybrid System. The system enables simultaneous imaging of coronary arteries with both intravascular ultrasound (IVUS) and Optical Coherence Tomography (OCT). IVUS or OCT are typically used by interventional cardiologists to image coronary anatomy during angioplasty and stenting procedures.

"This is the world's first intravascular imaging system for clinical use with the capability to acquire both IVUS and OCT images using a single catheter. IVUS and OCT are the two most commonly used intravascular imaging technologies in addition to angiography,” says Dr. Brian Courtney, President and CEO of Conavi. “The Novasight Hybrid System provides the resolution and contrast of OCT with the larger field of view of IVUS, and displays the images in a precisely co-registered fashion.”

Dr. Courtney continues, "This regulatory clearance represents an important milestone for the company as we build a portfolio of image guidance products for cardiovascular procedures. We are delighted to now be able to offer physicians in the USA the opportunity to use the Novasight Hybrid System to obtain intravascular images of coronary arteries as part of their care for patients undergoing interventional procedures.”