EDEN PRAIRIE, Minn., March 29, 2018 /PRNewswire/ -- MIVI Neuroscience, Inc. announced today it has received CE Mark approval for the R4Q Revascularization Catheter for the removal of fresh, soft emboli and thrombi in the peripheral and neurovascular systems.
The CE Mark approval is a significant accomplishment for MIVI Neuroscience. This approval enables the company to market and sell the R4Q Revascularization Catheters in European Union (EU) member countries for the treatment of ischemic stroke.
MIVI plans to immediately initiate commercial operations in Europe, and announced long term partnerships with two (2) highly respected and industry-leading distribution organizations in Europe: Neurologic Europe Ltd. in the United Kingdom, and Med-Italia Biomedica, S.r.l. in Italy. Both organizations are fully integrated industry leaders in the neurovascular space, each with significant experience in launching novel, patient focused technologies. MIVI plans to add more European partners shortly.
"We are very excited to begin a new and exciting phase of our company by initiating European commercialization based on R4Q's CE mark approval," said Jim McCollum, MIVI's CEO. "We believe our partners will be effective in delivering to the European interventional neurovascular community a new and novel suite of products including our family of Mi-Axus Guide Catheters and now the R4Q Revascularization Catheter – all designed to help physicians achieve success in in the removal of thrombus in patients experiencing ischemic stroke."
About MIVI Neuroscience
MIVI Neuroscience, Inc. is focused on developing and commercializing superior clinical solutions for neurointerventional procedures. Adoption of endovascular stroke therapy procedures is growing significantly worldwide since compelling data from multiple large-scale randomized trials in 2016 and 2017 confirmed the value to rapidly clear occlusive clot from large cerebral vessels. MIVI's innovative product portfolio provides physicians with unique devices designed to improve patient outcomes in these procedures by reducing complications, shortening procedure times and expanding treatment to more patients. More information about MIVI can be found on the website, www.mivineuro.com.
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SOURCE MIVI Neuroscience