FDA clears intravascular device billed as ‘world’s smallest camera’ as physicians share new data
Vena Medical, a Canada-based medtech company, has secured U.S. Food and Drug Administration (FDA) clearance for its Vena MicroAngioscope System—advertised as the “world’s smallest camera”—to be used for intravascular imaging in the peripheral arteries.
The device was designed to help care teams evaluate a patient’s peripheral vasculature without the use of X-ray fluoroscopy. It connects to standard endoscopy equipment and is used in tandem with a balloon distal access catheter to provide real-time color images. The balloon occludes the vessel temporarily and the segment is flushed with saline to enable the camera to directly image the interior of the vessel.
In Canada, more than 100 patients have already been treated with the Vena MicroAngioscope System. With this FDA clearance in place, the company now plans to enter the hospitals and health systems in the United States.
“This is a milestone moment for Vena Medical, unlocking the export market for the first time,” Michael Phillips, co-founder and CEO of Vena Medical said in a statement. “We built this technology to take physicians out of the dark. Having the device used in over 100 patients in Canada, we've seen firsthand how live, intravascular imaging changes patient care. With this FDA clearance, we are thrilled to bring that same transformative capability to the United States market.”
First-in-human analysis explores device’s potential in the cerebral vasculature
A new first-in-human analysis published in Stroke examined this device’s safety and effectiveness when deployed inside the cerebral vasculature. Researchers explored data from 20 endovascular patients treated with the first-generation version of the Vena MicroAngioscope System and another 11 patients treated with the current version.[1] All patients were treated at a high-volume facility in Canada.
“In the past, the large size of angioscopes, their poor flexibility, and limited image quality prohibited their adoption in the intracranial vasculature,” wrote senior author Peter Kan, MD, MPH, chair of neurosurgery with the University of Texas Medical Branch, and colleagues. “The MicroAngioscope was developed using coherent fiber bundle technology, which was designed to be used in the cerebral vasculature. Compared with previous coherent fiber bundle designs, the current MicroAngioscope is miniaturized with much improved flexibility and image quality, enabling it to be used in the intracranial vasculature for live direct visualization in conjunction with cerebral angiography.”
Overall, the device was consistently delivered to the exact location of interest and provided live visualizations. No vessel injuries related to cerebral angiography were reported. All patient cases were completed without complications.
“In this first-in-human study, we demonstrate early feasibility, safety, and potential utility of this novel intravascular imaging device as an adjunct to angiography,” the authors wrote. “Its role in routine practice will depend on prospective validation in larger, indication-specific cohorts.”
Click here to read the full study in Stroke, an American Heart Association publication.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.