Conavi Medical Inc. (formerly called Colibri Technologies Inc.), announced today that its Foresight ICE System has received FDA clearance for intraluminal ultrasound visualization of the heart and great vessels. It is the first catheter-based ultrasound that can provide both 2-D and 3-D images of cardiac anatomy around all sides of the catheter, according to the company.

"Our goal is to provide physicians, hospitals and industry partners with new opportunities to guide the increasing number of minimally invasive procedures available for a broad range of conditions," Brian Courtney, president and CEO of Conavi Medical, told HCB News. "The imaging needs for each type of procedure vary considerably."

The procedures vary from patient-to-patient and between the techniques, devices and clinical workflows that physicians deploy around the world. The Foresight ICE System will help physicians and health care systems refine how patients are treated, according to Courtney.

Currently, 2-D intracardiac echocardiography (ICE) is used in a large portion of certain procedures in the U.S. including atrial fibrillation procedures and certain structural heart interventions like closure of atrial septal defects. Those patients might also undergo CT, MR or TEE before the procedure in order to get a 3-D view of the anatomy.

"The development of 3-D ICE provides an opportunity to explore how catheter-based imaging can be used to collect some of the 3-D anatomy currently collected with those other modalities, and perhaps some aspects of the 3-D anatomy that are not well captured with these more conventional 3-D imaging technologies," said Courtney.

Foresight ICE System has currently only been introduced in the U.S., but Conavi Medical is looking to gain approval for it in Europe and Japan in the future.

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