Medical devices & diagnostics · Stroke intervention
Vena Medical
A sub-millimetre camera that looks forward from inside a brain artery, and a balloon catheter built to pull a clot out on the first try. Licensed across the vasculature in Canada, cleared in the United States for peripheral and coronary vessels only.
November 14, 2023
The patient at The Ottawa Hospital had had several strokes, and nobody could say why. CT and MRI had both been run, and neither settled it.
Dar Dowlatshahi, the neurologist on the case, knew of a camera being built in Kitchener. He and interventional neuroradiologist Robert Fahed won one time Health Canada approval to use it on this patient.
Fahed threaded the device from the groin into the vessels of the patient’s brain and switched on the light.
“We have never been able to see what’s inside the vessels,” he told CBC News afterwards. The room saw the lesion at once. A stent went in during the same sitting, the whole thing inside an hour, and the patient has not had a stroke since.
What an angiogram cannot show
Endovascular medicine runs on X-ray. Contrast fills the vessel, fluoroscopy renders a grey silhouette, and the physician infers the rest. Ultrasound and optical coherence tomography add slices that look sideways.
Vena’s answer: put a camera in there and look forward. The MicroAngioscope returns full colour video from inside the lumen. It needs a bloodless field, so it works with a balloon that briefly occludes the segment while saline flushes it clear.
The second product came out of the first. In thrombectomy, physicians run a balloon guide catheter up the neck to stop flow, then a separate catheter into the brain for the clot. The Vena Balloon Distal Access Catheter folds those into one, so the balloon sits at the clot. The metric it targets is first pass effect.
“There are some studies showing that the first pass success rate can be as low as 25.1 per cent, and our goal is to get that number as high as possible,” Michael Phillips told The Record in 2022.
Two engineers with doctors at the dinner table
Phillips and Phillip Cooper met as mechanical engineering undergraduates at Waterloo and built the first version as their fourth year capstone project. Between the two families there are seven physicians. Cooper’s father, an interventional radiologist, supplied the idea. They sat in on procedures and kept hearing one complaint: not enough information.
They incorporated in 2016 and went full time on graduation. Velocity, Waterloo’s incubator, gave them lab space. A $50,000 award from the Palihapitiya/Lau Venture Creation Fund paid for early work, alongside the Norman Esch Capstone Design Awards and Velocity Fund Finals. Then TMCx in Houston, then Y Combinator, where TechCrunch named them one of its seven picks of the Demo Day batch. Then back to Kitchener.
The catheter first, then the camera
Health Canada licensed the balloon catheter on January 26, 2022. The first five patients anywhere were treated in August 2022, at London Health Sciences Centre University Hospital and The Ottawa Hospital. In July 2024 The Ottawa Hospital adopted it into its stroke protocol, after an evaluation run through the Ontario Bioscience Innovation Organization’s Early Adopter Health Network.
The camera took longer. A Health Canada system licence covering peripheral, coronary and neurovascular use was first issued on June 6, 2025, and announced in late September. The FDA granted Breakthrough Device designation in February 2025, then cleared the device twice: first for peripheral vessels in October 2025, then for peripheral and coronary vessels in January 2026. Neither US clearance covers the brain.
In February 2026 the first in human paper landed in Stroke. Thirty one intracranial cases, no complications, no vessel injury seen on angiography. The authors wrote that “Further studies are needed to determine its relevance in daily practice.” Senior author Peter Kan then ran the first US commercial cases at his own centre, the University of Texas Medical Branch. Staten Island University Hospital became the second US site in May 2026.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA 510(k) K251767 | Cleared Oct 1, 2025. Class II angioscope, code LYK, 21 CFR 876.1500. Predicate: Olympus AF Angioscope System, K911278. Indication: observation of the interior of blood vessels of the peripheral vasculature. Specified at 160 cm working length, 3 French at the distal tip. | Public record |
| FDA 510(k) K253842 | Cleared Jan 28, 2026. Predicate: 4.5F ImageCath Coronary Angioscope, K952638. Reference device: Vena’s own K251767. Indication widened to vascular disease within the peripheral and coronary vessels. | Public record |
| Health Canada licences | Licence 107319, Vena Balloon Distal Access Catheter, Class II, first licensed Jan 26, 2022. Licence 113472, Vena MicroAngioscope System, Class II, first licensed Jun 6, 2025, covering peripheral, coronary and neurovasculature. | Public record |
| First in human study | Stroke, April 2026, 57(4):883 to 889. Prospective single arm multicentre observational study of 31 cases: 11 transverse sinus stentings, 9 carotid stents, 6 flow diversions, 3 aneurysm treatments, 2 thrombectomies. No complications, no angiographic vessel injury, all patients neurologically unchanged. Three co-authors disclose stock in Vena Medical. | Public record |
| Preclinical papers | JNIS 2019, a 1.7 French prototype in a porcine model. AJNR 2021, animal and cadaveric models, mean utility ratings 3.0 to 4.7 on a five point scale. SVIN 2024, a rabbit flow diverter study in which neointimal thickness by angioscopy correlated with histology at r = 0.72. Phillips and Cooper are co-authors on all three. | Public record |
| Breakthrough Device designation | Announced by the company in February 2025 and presented at the International Stroke Conference. FDA publishes no roster of designations. It is a review pathway, not a clearance. | Company-stated |
| US indication versus the framing | Company materials and much of the coverage present this as a neurovascular and stroke tool. Neither US clearance reaches the neurovasculature; the Canadian licence does. | Differs from the record |
| Device diameter | Figures do not agree. The FDA summary gives 3 French, 0.040 inch, at the distal tip. Coverage says under one millimetre. A University of Waterloo article says one third of a millimetre. | Differs from the record |
| First pass effect at The Ottawa Hospital | 64 per cent against a stated industry average of 44 per cent, from a July 2024 company release reported by NeuroNews. No peer reviewed publication of the VANISH evaluation could be found. | Company-stated |
| Case volume | More than 30 Canadian cases by Sep 2025, more than 100 by Feb 2026. Company figures, not audited. | Company-stated |
| Registered trials | No ClinicalTrials.gov registration found for VANISH or the first in human study, as of Sep 22, 2026. | Not found |
Read plainly: the hardware is real, the regulatory record is solid on both sides of the border, and there is now peer reviewed first in human safety data. What is missing is a comparative outcome. Thirty one cases with no complications says the device is safe; it does not say patients do better. The 64 per cent first pass figure is the closest thing to an outcome claim, and it sits in a press release, not a journal.
What to watch
- A US neurovascular indication. Everything the company is known for happens in the brain, where neither US clearance reaches.
- Publication of the VANISH results, or any controlled comparison behind the 64 per cent figure.
- How many US hospitals follow UTMB and Staten Island, and whether procedure volumes are ever named.
- Response from the incumbents. Stryker, Penumbra, Medtronic and Route 92 sell into the same suite, and several physician investigators on Vena’s papers consult for them.
In their words
“What I would say about this technology is it’s absolutely groundbreaking.”
Dar Dowlatshahi, neurologist, The Ottawa Hospital, to CBC News, 2024 · Independent
“As soon as we used the camera and we went into that vessel, everybody in the room immediately saw what it was and determined what the lesion was.”
Robert Fahed, interventional neuroradiologist, The Ottawa Hospital, to CBC News, 2024 · Independent
“Using an X-ray is like using GPS only to navigate, but having a camera is like seeing through a window.”
Michael Phillips, co-founder and CEO, University of Waterloo · Company
“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.”
Peter Kan, University of Texas Medical Branch, NeuroNews International, 2025 · Independent
“The Vena MicroAngioscope is the only tiny camera that’s able to go inside the small blood vessels in someone’s brain.”
Phillip Cooper, co-founder, to CP24, October 2025 · Independent
“It’s been a slog, for sure. But these last six months have moved very fast. Everything fell into place, the physicians are loving it, and we’re getting great results with patients.”
Michael Phillips, Medical Innovation Xchange profile, September 2025 · Interview
Related companies
Sources
- Public recordFDA 510(k) clearance letter and summary, K251767, Vena MicroAngioscope System
- Public recordFDA 510(k) clearance letter and summary, K253842, Vena MicroAngioscope System
- Public recordHealth Canada MDALL licence 107319, Vena Balloon Distal Access Catheter
- Public recordHealth Canada MDALL licence 113472, Vena MicroAngioscope System
- Public recordVisualization of the Human Intracranial Vasculature and Intracranial Implants Using Microangioscopy
- Public recordPreclinical microangioscope studies
- IndependentVena Medical gains US FDA Breakthrough Device designation
- IndependentVena Medical completes first U.S. cases with the camera system
- IndependentThis tiny camera means big things when it comes to treatment of stroke patients, doctors say
- IndependentKitchener, Ont. medical company receives Health Canada licence for tiny camera
- IndependentFDA clears intravascular device billed as the world’s smallest camera as physicians share new data
- IndependentStroke victims in Canada first to benefit from Kitchener startup’s new surgical device
- IndependentThe Ottawa Hospital first to adopt Vena Medical’s BDAC device
- InterviewMIX Profile: Michael Phillips, co-founder and CEO of Vena Medical
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
