Vena Medical’s Balloon Distal Access Catheter Investigated in Canada With First-Ever Procedures

August 16, 2022—Vena Medical, a Canada-based developer of neurovascular devices, announced the successful treatment of the first five patients in the world using the Vena balloon distal access catheter (BDAC) at London Health Sciences Centre (LHSC) University Hospital in London, Ontario, and The Ottawa Hospital (TOH) in Ottawa, Ontario, Canada.

According to the company, the Vena BDAC device combines the attributes of the balloon-guide catheters and distal access catheters that are currently used in thrombectomy to remove clots from the brains of stroke patients.

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, noted the company.

Sachin Pandey, MD, and Michael Mayich, MD, completed the procedure at the LHSC-University Hospital.

Dr. Pandey commented in the Vena Medical’s press release, “12/10 navigability. The BDAC isn’t even comparable to the competitors. I easily pulled back the stentriever and clot all the way through the lumen of the BDAC with zero resistance. You can’t do this with the current devices on the market.”

Robert Fahed, MD, of TOH, added, “The Vena BDAC is a category-defining device and we’re excited to be the first in the world to evaluate its performance. Each case has been successful so far with the BDAC getting the clot out on the first try, every time.”

Vena Medical advised that further investigational studies are planned in Canada as the company pursues additional regulatory clearances, including FDA clearance.

These studies will include VANISH, an “evaluation of a new balloon distal access catheter for stroke thrombectomy” with Principal Investigator Brian Drake, MD, attending Neurosurgeon and Interventional Neuroradiologist at TOH, and Co-Principal Investigator Dr. Fahed, who is attending Neurologist and Interventional Neuroradiologist at TOH.

The other centers in Canada included in the VANISH trial and/or evaluating the Vena BDAC are LHSC-University Hospital with investigators Dr. Mayich and Dr. Pandey; Windsor Regional Hospital in Windsor, Ontario, with investigators Matthew Rochon, MD, and Erin Dyer, MD; University of Alberta Hospital in Edmonton, Alberta, with investigator Jeremy Rempel, MD; and Foothills Medical Centre in Calgary, Alberta, with investigator Mohammed Almekhlafi, MD.

VANISH is funded by the Ontario Bioscience Innovation Organization’s Early Adopter Health Network, noted Vena Medical.