Vena Medical has been granted Breakthrough Device designation from the US Food and Drug Administration (FDA) for its MicroAngioscope, marking what the company describes as a “historic leap forward” in neurovascular care and stroke treatment.
For the first time ever, Vena claims, direct intracranial angioscopy is now possible—meaning real-time, high-definition imaging inside brain blood vessels can be provided before, during and after neurointerventional procedures. As stated in a recent company press release, having already proved its life-saving impact in Canada, this cutting-edge technology is now poised to “redefine” stroke treatment in the USA under the FDA’s Breakthrough Devices programme.
Traditional imaging methods provide only indirect views, often leaving clinicians without immediate feedback during critical procedures, according to Vena. In contrast, the MicroAngioscope has the potential to offer direct visualisation via high-definition imaging of lesions, vessel walls and devices during neurointerventional procedures, enhancing stroke diagnosis; optimised decision-making, with immediate confirmation of diagnoses and treatment success, reducing procedural risks and potentially improving long-term patient outcomes; and real-time feedback, boasting the ability to identify thrombus, endothelialisation and proper wall apposition for intracranial stents, arming physicians with greater precision during stroke interventions.
Through the US FDA’s Breakthrough Devices programme, Vena is set to benefit from priority review and dedicated regulatory guidance. The company’s recent release notes that this partnership will accelerate its efforts to secure full market clearance and pave the way for the MicroAngioscope to significantly improve stroke care.
First-in-human experiences with the MicroAngioscope were showcased by Peter Kan (University of Texas Medical Branch, Galveston, USA) at the 2025 International Stroke Conference (ISC; 5–7 February, Los Angeles, USA), as he also announced the FDA Breakthrough Device designation. Kan’s presentation detailed how this innovative imaging tool is enhancing neurovascular procedures, and setting a “new global standard” in stroke care and neurovascular procedures.
“I’ve seen the MicroAngioscope evolve from preclinical testing to clinical use, and the latest advancements in field of view and image quality are remarkable,” he commented. “This FDA breakthrough designation brings us closer to transforming neurovascular treatment with real-time intracranial visualisation.”
“Seeing what is happening inside the brain’s blood vessels in real time changes everything,” added Michael Phillips, co-founder and chief executive officer (CEO) of Vena. “Physicians in Canada are already leveraging the MicroAngioscope to deliver more precise and confident care. With the FDA’s Breakthrough Device designation, we are one step closer to bringing this transformative technology to stroke patients across the USA.”
