Vena Medical has announced that the first five patients in the world have now received treatment with its Vena Balloon Distal Access Catheter (BDAC).
The procedures were completed at London Health Sciences Centre (LHSC) University Hospital and The Ottawa Hospital (TOH) in Canada.
Vena BDAC has been developed in Canada for patients requiring mechanical thrombectomy during ischemic stroke treatment.
It combines distal access catheters and balloon guide catheters, which are now used in thrombectomy to remove blood clots from the brains of patients with stroke.
The combination of the two catheters allows clinicians to bring the balloon closer to the clot and remove it on the first try.
This will lead to significantly better patient outcomes. The system also reduces the number of devices used to treat each patient as well as the cost of procedures.
Vena Medical CEO Michael Phillips said: “We’re 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.
“This is cutting-edge technology that would normally need to be launched somewhere far from here, but we’re excited to make an impact locally before we make an impact globally.”
The company stated that further investigational studies on the Vena BDAC are planned in Canada.
This includes the VANISH (eVAluatioN of a new balloon dIstal access catheter for Stroke tHrombectomy) trial, which will be funded by the OBIO Early Adopter Health Network.
Windsor Regional Hospital, Foothills Medical Centre in Calgary, University of Alberta Hospital in Edmonton and London Health Sciences Centre-University Hospital will also be included in the trial and/or evaluate the Vena BDAC.
Furthermore, Vena Medical intends to seek additional regulatory approvals from the US Food and Drug Administration (FDA).