Vena Medical has announced the first Health Canada medical device licence for its new product, the Vena balloon distal access catheter, which combines the balloon guide catheters and distal access catheters that are currently used in thrombectomy to remove clots from the brains of stroke patients.
And, as per a press release from Vena Medical, 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.
“Obtaining important regulatory clearances like this one, coupled with the expansion of our team through key senior hires is allowing us to transition from a start-up to a scale-up,” said Vena Medical president and co-founder Phil Cooper. “The timing of this milestone and the recent addition of Adam Karamath as Vena Medical’s head of commercial operations could not be better.”
With distal occlusion, the release continues, the goal is to improve perioperative success metrics that are already proven to lead to better patient outcomes. The company further claims that the Vena balloon distal access catheter is the only device capable of providing that distal occlusion in thrombectomy.
“The issuance of our first Health Canada medical device licence shows that we are capable of bringing innovative solutions to the neurovascular space,” said Vena co-founder and CEO Michael Phillips. “The Vena BDAC [balloon distal access catheter] is the result of intensive collaboration with physicians who perform these procedures every day.
“We could not be more excited that our first regulatory success is right here in Canada, and this means the first patients in the world to benefit from our technology are going to be Canadian.”