Vena Medical Celebrates First Procedures with Category-Defining Balloon Distal Access Catheter™ (BDAC)

Kitchener, Ontario, Aug. 16, 2022 (GLOBE NEWSWIRE) — Vena Medical, a leading developer of cutting-edge neurovascular devices, announces the successful treatment of the first five patients in the world using the Vena BDAC™ at London Health Sciences Centre (LHSC) University Hospital and The Ottawa Hospital (TOH). 

Thrombectomy, a minimally invasive procedure to remove a blood clot, is now standard of care treatment for patients with an acute ischemic stroke (AIS) secondary to a Large Vessel Occlusion (LVO)¹. There are several techniques available, all with the objective of restoring blood flow as quickly as possible. The 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 victims. 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 outcomes². This also reduces the number of devices to treat each patient and therefore the cost of the procedure.

“12/10 navigability. The BDAC isn’t even comparable to the competitors,” describes Dr. Sachin Pandey, who completed the procedure alongside Dr. Michael Mayich in London, ON at the London Health Sciences Centre-University Hospital. “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.”

“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” says Michael Phillips, the CEO of Vena Medical. 

“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” said Dr. Robert Fahed of The Ottawa Hospital. 

Further investigational studies are planned in Canada while Vena Medical pursues additional regulatory clearances such as the FDA, and include the VANISH trial (“eVAluatioN of a new balloon dIstal access catheter for Stroke tHrombectomy”), funded by the OBIO Early Adopter Health Network with Principal Investigator Dr. Brian Drake, attending Neurosurgeon and Interventional Neuroradiologist, and Co-Principal Investigator Dr. Robert Fahed, attending Neurologist and Interventional Neuroradiologist at The Ottawa Hospital. Other centres included in the VANISH trial and/or evaluating the Vena BDAC™ are London Health Sciences Centre-University Hospital (Drs. Michael Mayich and Sachin Pandey), Windsor Regional Hospital (Drs. Matthew Rochon and Erin Dyer), University of Alberta Hospital, Edmonton (Dr. Jeremy Rempel) and Foothills Medical Centre, Calgary (Dr. Mohammed Almekhlafi). 

About Vena Medical

Vena Medical, an ISO 13485 and MDSAP certified company, is creating a suite of tools to change the way physicians perform minimally invasive neurosurgery, starting with the Vena Balloon Distal Access Catheter™, currently available in Canada. Its flagship product is the world’s smallest camera, which allows physicians to see inside veins and arteries, to help them treat stroke. The need for this new product has been evident in stroke treatment through pre-clinical trials published in the American Journal of NeuroRadiology and the Journal of NeuroInterventional Surgery^3,4. Vena Medical is part of the MIX (Medical Innovation Xchange) group of companies https://medicalinnovationxchange.com.

For more information on Vena Medical visit www.venamed.ca.

PR Contact

Mary Kate Phillips
(877) 560-8362
[email protected]

Investor Contact

Michael Phillips, CEO
(877) 560-8362
[email protected]

About The Ottawa Hospital

The Ottawa Hospital is one of Canada’s largest learning and research hospitals with over 1,100 beds, approximately 12,000 staff and an annual budget of over $1.2 billion. Our focus on research and learning helps us develop new and innovative ways to treat patients and improve care. As a multi-campus hospital, affiliated with the University of Ottawa, we deliver specialized care to the Eastern Ontario region, but our techniques and research discoveries are adopted around the world. We engage the community at all levels to support our vision for better patient care. See www.ohri.ca for more information about research at The Ottawa Hospital.

About London Health Sciences Center

London Health Sciences Centre provides health care to patients from across Western Ontario and as far north as Thunder Bay, advances the frontiers of health sciences research, helps train tomorrow’s health care professionals, and provides health system leadership to shape the future of care. Since the founding of its predecessor, London General Hospital, in 1875, LHSC has grown to encompass Victoria, University and Children’s Hospitals, two family health care centres and the Kidney Care Centre. LHSC provides highly complex and advanced forms of care, including transplant, cardiac and critical care as well as delivering the regional cancer program.

References:

1. Parthasarathy R, Gupta V. Mechanical Thrombectomy: Answering Unanswered. Ann Indian Acad Neurol. 2020 Jan-Feb;23(1):13-19. doi: 10.4103/aian.AIAN_359_19. PMID: 32055116; PMCID: PMC7001454.
2. Jeong DE, Kim JW, Kim BM, Hwang W, Kim DJ. Impact of Balloon-Guiding Catheter Location on Recanalization in Patients with Acute Stroke Treated by Mechanical Thrombectomy. AJNR Am J Neuroradiol. 2019 May;40(5):840-844. doi: 10.3174/ajnr.A6031. Epub 2019 Apr 4. PMID: 30948374; PMCID: PMC7053901.
3. Srinivasan VM, Lazaro TT, Srivatsan A, Cooper P, Phillips M, Garcia R, Chen SR, Johnson JN, Burkhardt JK, Collins DE, Kan P. Applications of a Novel Microangioscope for Neuroendovascular Intervention. AJNR Am J Neuroradiol. 2021 Jan;42(2):347-353. doi: 10.3174/ajnr.A6900. Epub 2020 Dec 24. PMID: 33361372; PMCID: PMC7872190.
4. Lazaro T, Srinivasan VM, Cooper P, Phillips M, Garcia R, Chen SR, Johnson J, Collins DE, Kan P. A new set of eyes: development of a novel microangioscope for neurointerventional surgery. J Neurointerv Surg. 2019 Oct;11(10):1036-1039. doi: 10.1136/neurintsurg-2018-014610. Epub 2019 Mar 16. PMID: 30878951.

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