Vena Medical has today announced that Health Canada has issued a Medical Device Licence for the company’s MicroAngioscope system, authorising its use to visualise the interior of blood vessels in the peripheral, coronary and neuro vasculatures.
Vena’s MicroAngioscope—claimed by the company to be the first intravascular imaging device with a licensed neurovascular indication worldwide—is less than one millimetre in diameter and provides physicians with real‑time, full‑colour, direct visualisation from inside the blood vessel to complement existing imaging modalities. According to Vena, being able to see inside the blood vessel during a procedure gives physicians real-time feedback to help with decision-making as they treat their patients.
As of September 2025, the MicroAngioscope system has been used in more than 30 commercial cases across Canada, including procedures performed at the Ottawa Hospital in Ottawa, Toronto Western Hospital in Toronto, University of Alberta Hospital in Edmonton, and Royal University Hospital in Saskatoon.
“Direct visualisation provides information that angiography alone simply can’t,” said Jeremy Rempel (University of Alberta Hospital, Edmonton, Canada). “Seeing intraluminal detail in real time has the potential to inform decision‑making across a range of neurovascular procedures.”
“From a clinician’s perspective, adding colour, motion and surface detail from inside the vessel is a paradigm shift,” added Robert Fahed (The Ottawa Hospital, Ottawa, Canada). “It’s an additional lens we can bring to complex cerebrovascular cases.”
“As programmes standardise on contemporary imaging tools, having intravascular, true‑colour visualisation available in the neuro suite can meaningfully complement our existing armamentarium,” commented Pascal Mosimann (Toronto Western Hospital, Toronto, Canada).
The MicroAngioscope system is now available for sale and clinical use in Canada—but, while it has also been designated as a US Food and Drug Administration (FDA) Breakthrough Device, it has not been fully cleared or approved by the regulator in the USA.
Vena is also sponsoring and presenting at the Pan-Canadian Interventional Neuroradiology/Neurology/Neurosurgery Karel Ter Brugge Educational Symposium (PIKES 2025; 25–27 September, Toronto, Canada), where attendees will be able to experience hands‑on demonstrations of the MicroAngioscope system at the company’s booth, and hear from its clinical team during multiple sessions on direct intravascular visualisation.
“Health Canada’s licence opens a new era for real-time intravascular imaging throughout the entire vascular system, including the brain,” stated Adam Karamath, senior director of commercial operations at Vena. “With more than 30 successful commercial cases, Vena is bringing this technology into Canada first, where clinical adoption is beginning to show benefits already.”
