Following its recent regulatory clearance from the U.S. Food and Drug Administration (FDA), Vena Medical today announced the successful completion of the first commercial cases in the United States using the Vena MicroAngioscope System™. The procedures were led by Dr. Peter Kan, Professor and Chair of Neurosurgery, and Dr. Chris Young, Assistant Professor of Neurosurgery at the University of Texas Medical Branch (UTMB).
With this milestone, UTMB becomes the first healthcare institution in the United States to commercially adopt the Vena MicroAngioscope System™.
The UTMB Health team has completed seven cases to date using the technology, beginning with a carotid artery stenting procedure. By utilizing the world’s smallest camera, the Vena MicroAngioscope System™ provides physicians with an unprecedented, live, full-colour view from inside the vasculature. This allows doctors to directly image complex lesions and confidently tailor their treatment decisions, such as stent choice and stent-vessel interaction, in real-time, leading to safer, more effective procedures.
"Our team recently completed the first U.S. commercial procedures utilizing this direct-imaging system," said Dr. Peter Kan, Professor and Chair of Neurosurgery at UTMB. "The device provides real-time, intravascular colour visualization, which we used to directly assess the target lesions and observe the placement of the stents during the interventions."
The commercial launch at UTMB builds upon a deep, multi-year foundation of clinical collaboration between Vena Medical and Dr. Kan. The Vena and UTMB teams have partnered on extensive investigational research, with Dr. Kan authoring four peer-reviewed publications. This includes recent first-in-human clinical data with the Vena MicroAngioscope System, which was published in the prestigious American Heart Association (AHA) Stroke journal.
"We are thrilled to officially launch the Vena MicroAngioscope System™ in the United States alongside Dr. Peter Kan and the exceptional team at UTMB," said Michael Phillips, Co-founder & CEO of Vena Medical. "Dr. Kan has been a pioneering partner for years, helping us validate this technology through rigorous academic research and multiple publications. To now see the device in his hands in our first U.S. commercial cases, impacting real patients, is a gratifying achievement for the entire Vena Medical team."
The U.S. limited market release follows Vena Medical's recent FDA 510(k) announcement and grand opening of its $4.5M Manufacturing Centre of Excellence in Kitchener, Ontario, enabling the company to scale production to meet the demands of the US market.
Vena Medical, co-founded by Michael Phillips and Phil Cooper while at the University of Waterloo, develops direct intravascular imaging that helps physicians see inside veins and arteries in real time. This new view changes the way they treat their patients, leading to better patient outcomes. Vena Medical is headquartered in Kitchener, Ontario. For those interested in joining our waitlist, please visit www.venamed.ca.
