Skip links

Vena Medical achieves first regulatory clearance

Kitchener, ON – February 3, 2022– The Medical Innovation Xchange (MIX) is proud to congratulate Vena Medical as they reach a critical and exciting milestone; the first Health Canada Medical Device License for their new product, the Vena Balloon Distal Access Catheter™[1] (BDAC). The Vena BDAC™ combines the balloon guide catheters and distal access catheters that are currently used in thrombectomy to remove clots from the brains of stroke victims. Combining these two devices allows the clinician to get the balloon much closer to the clot, which is shown to improve key metrics like First Pass Success Rate, allowing removal of the clot on the first try and leading to significantly better patient outcomes. This also reduces the number of devices to treat each patient and therefore the cost of the procedure.
Canadian medtech companies face unique challenges as they develop their products, which often prohibits their growth in Canada. MIX offers a space where these scaling companies can grow, succeed, and hopefully remain in Canada – taking advantage of the innovation ecosystem, talent pipeline and contributing to patient outcomes and clinician success. One of the areas where MIX companies find the greatest support is in regulatory affairs. Vena Medical is one of the inaugural companies in residence at MIX and contributes to the success of the entire ecosystem. For more information please go here:
“When a company like Vena Medical achieves success it not only inspires other early-stage companies, but it validates the great opportunities that MIX has across the medtech ecosystem. We are all so excited for the team at Vena and look forward to their growth” says MIX Executive Director Elliot Fung.
Michael Phillips, co-founder and CEO of Vena Medical states
“MIX is the sort of organization that makes Kitchener-Waterloo full stack for medical device companies like ours. University of Waterloo, Communitech and Velocity fostered our early-stage company development while MIX provides the specific advice that we need at later stages, such as getting ISO 13485 certificates, regulatory clearances and eventually sales”
"In medtech, regulatory approval signals the evolution of a company from start-up to scale-up. It is fantastic to watch Vena achieve this significant milestone and be that much closer to helping patients with their innovations" said MIX co-founder Armen Bakirtzian.

About Vena Medical

Vena Medical, an ISO 13485 and MDSAP certified company, is creating a suite of tools to change the way physicians perform minimally invasive neurosurgery. Its flagship product is the world's smallest camera, which allows physicians to see inside veins and arteries, to help them treat stroke. The need for this new product has been evident in stroke treatment (a $1B market opportunity in the US alone) through pre-clinical trials published in the American Journal of NeuroRadiology and the Journal of NeuroInterventional Surgery. For more information on Vena Medical visit

About the Medical Innovation Xchange (MIX)

MIX is Canada’s first industry-led hub dedicated to helping medical technology startups scale successfully in Canada. MIX was created to reduce the barriers and bridge the resource gap that medical technology startups face as they move from along the entrepreneurial journey from idea generation to commercialization. Our vision is a thriving ecosystem that develops, attracts and retains Canadian medical technology companies and establishes Waterloo Region as a leader in medical innovation. The mission behind MIX is to provide a collaborative environment for medical technology companies that supports their individual growth and adds to the overall success of the growing local ecosystem.

Media Contacts

Mary Kate Phillips, Marketing, Vena Medical

Elliot Fung, Executive Director, MIX
[1] *Vena Balloon Distal Access Catheter is licensed in Canada only