Neuravi wins CE Mark for EmboTrap II stent retriever

Neuravi said today it won CE Mark approval in the European Union for its EmboTrap II stent retriever and revascularization device.

The device is a next-gen version of the company’s EmboTrap, and is designed to treat a broader range of clots with sizes that are deliverable through a 0.021″ microcatheter.

“The EmboTrap platform has been a great addition to my clinical practice. In my first nine cases using the device, I was able to get TICI 2b-3 reperfusion in one pass. Now with the EmboTrap II, I’ve had comparably good results when treating longer occlusions. In fact, in early evaluations of the EmboTrap II 5×33 at six centers, 16 of 17 cases resulted in TICI 2b-3 flow. The open design of the device helps trap clot inside and also makes it quite flexible, which is important when removing clot from the arteries of the brain,” Dr. Christian Taschner of Germany’s University of Freiburg said in a press release.

The company said it will be introducing the system at the 8th annual Congress of the European Society of Minimally Invasive Neurological Therapy in Nice, France this week.

“Neuravi is committed to ongoing research to deepen our understanding of the science of clot and to find new ways to advance stroke therapy. As the company continues to gain new insights into clot-device interaction, that learning informs ongoing innovation. We believe this scientific approach not only improves our technology to make it better and easier to use for physicians, but will also maximize clinical benefits for patients. We are extremely happy with the clinical reception to date of the EmboTrap II and look forward to offering the technology more broadly to physicians over the next few months,” CEO Eamon Brady said in prepared remarks.

Last November, Neuravi said it enrolled the 1st patient in a clinical trial of its novel EmboTrap revascularization stent retriever device for treating acute ischemic stroke.

Data from the study will be submitted as part of Neuravi’s FDA premarket approval application, the Ireland-based company said.

The Embotrap device functions by capturing clots and allowing blood flow to resume immediately after the clot has been secured in patients who have experienced a stroke, CEO Eamon Brady told MassDevice.com in an interview last June.

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