Vena Medical has announced the successful treatment of the first five patients in the world using its Vena Balloon Distal Access Catheter (BDAC) at London Health Sciences Centre University Hospital (London, Canada) and The Ottawa Hospital (Ottawa, Canada).
The Health Canada-approved 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 patients.
As per a company press release, 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.
“Twelve out of 10 navigability. The BDAC is not even comparable to the competitors,” said Sachin Pandey, who completed the first procedure alongside Michael Mayich (both London Health Sciences Centre University Hospital, London, Canada). “I easily pulled back the stentriever and clot all the way through the lumen of the BDAC with zero resistance. You cannot do this with the current devices on the market.”
The procedure was performed through a tiny incision over the right hip and took less than 10 minutes, reconstituting blood flow to a large part of the brain, and restoring the patient’s movement and speech almost immediately—according to a London Health Sciences Centre press release.
“Performing more than 200 emergency stroke surgeries each year, our team at London Health Sciences Centre knows the importance of identifying strokes and acting quickly,” said Mayich. “When a blood clot is causing a stroke, over two million brain cells can be lost each minute, so seconds count. By locating and removing the clot in a shorter period of time, the patient has a higher probability of regaining mobility and speech. This device offers the possibility of removing clots in fewer attempts, shortening the procedure and maximising the chances of good outcomes for our patients.”
“The Vena BDAC is a category-defining device, and we are excited to be the first in the world to evaluate its performance,” added Robert Fahed (The Ottawa Hospital, Ottawa, Canada). “Each case has been successful so far, with the BDAC getting the clot out on the first try every time.”
Further investigational studies are planned in Canada while Vena pursues additional regulatory clearances, such as from the US Food and Drug Administration (FDA), and include the VANISH trial with principal investigator Brian Drake (The Ottawa Hospital, Ottawa, Canada) and co-principal investigator Fahed.
“We are proud to have the first patients to benefit from our Canadian-developed technology within driving distance of our office, in the hands of world-class physicians,” said Vena CEO Michael Phillips. “This is cutting-edge technology that would normally need to be launched somewhere far from here, but we are excited to make an impact locally before we make an impact globally.”