KITCHENER — Stroke victims in Canada will be the first to benefit from a new surgical device from Kitchener-based medical technology startup Vena Medical.
The product, called the Vena Balloon Distal Access Catheter, received a medical device license from Health Canada, paving the way for its use in surgeries to remove blood clots from the brains of stroke victims.
“The first regulatory clearance we’re getting is in Canada, which is really exciting,” said co-founder and CEO Michael Phillips, adding that they’ll likely be working towards US Food and Drug Administration approval. United later this year.
“We have big ambitions,” he said. “We have an immediate plan to try to start helping patients across North America, but we’ve also been keeping our eye on Europe and other key markets like that, just to understand what those regulatory landscapes.”
With the Canadian license in place, Vena Medical is initially working with a few Ontario hospitals with the goal of launching a pilot project this year, putting the device for use in the operating room.
Vena’s product combines two devices – balloon guide catheters and distal access catheters – currently used in thrombectomy, a minimally invasive procedure used to remove clots from blood vessels.
The most common type of stroke occurs when a clot blocks or reduces blood flow to the brain.
Blood flowing behind the clot can lodge it further in place, so surgeons can temporarily restrict blood flow by inflating a tiny balloon in a carotid artery in the neck using a balloon guiding catheter. A second catheter is deployed into the brain with tools to remove the clot.
The Vena Medical device combines the two, allowing the balloon to be inflated much closer to the clot – reducing any collateral blood flow and increasing the chances of removing it on the first try, Phillips said.
“We kind of go to the extreme, where we take the ball to the clot,” he said.
“The most important thing for the patient is to get that clot out the first time. … If you have to go multiple times to try and get the clot out, there’s always more inherent risk.
Patients in whom a clot was removed on the first attempt have also been shown to recover significantly better, Phillips said.
“Some studies show that the first-pass success rate can be as low as 25.1%, and our goal is to get that number as high as possible.”
From a practical point of view, cost savings can also be achieved by incorporating two devices into one. Surgical times are also shortened if the clot is removed on the first try.
Founded in 2016 by Phillips and Phil Cooper, Vena Medical began as a fourth-year engineering design project at the University of Waterloo.
Their unique catheter actually stems from their work on their first device, a microangioscope or camera that will allow doctors to see inside veins and arteries. Phillips said their goal is to develop a suite of products that will work together.
Their research and development to date has been supported by awards, grants and investors. After completing its first preclinical study at the TMCx Medical Accelerator in Texas and participating in the prestigious Y Combinator Accelerator, Vena Medical’s seven-person team is based at Kitchener’s Medical Innovation Xchange (MIX).
“Phil and I basically decided that the perfect place to continue to grow the business was actually KW,” Phillips said. “There are great talents in the region. Things like even office spaces are much more reasonably priced here.
MIX also provides a supportive environment for like-minded innovators, he said. “We saw that willingness and openness to help places like MIX, and that definitely drew us here.”