Neuravi Announces European Launch of EmboTrap II Stent Retriever

September 8, 2016—Neuravi announced European CE Mark approval and launch of the company’s newly available enhancements to the EmboTrap stent retriever platform, the EmboTrap II revascularization device. Neuravi will be introducing the EmboTrap II system at the 8th annual congress of the European Society of Minimally Invasive Neurological Therapy held September 8–10, 2016 in Nice, France.

The new device is composed of the company’s EmboTrap platform design, which is engineered to trap and remove a variety of clot types and rapidly re-establish flow, with an integrated fragment protection zone. The EmboTrap II device is designed to address a broader range of clot lengths, with sizes that are deliverable through a 0.021-inch microcatheter.

The EmboTrap was fully commercialized in Europe in 2015. The EmboTrap and EmboTrap II revascularization devices are available in Europe to treat patients with acute ischemic stroke.

In the United States, the EmboTrap is currently available for investigational use only under the ARISE II clinical trial. ARISE II is an international clinical trial assessing safety and effectiveness in the United States and Europe. Data from the trial will support a US Food and Drug Administration submission for approval to market the device in the United States.

In the company’s press release, Christian Taschner, MD, who is Professor of Radiology at University of Freiburg in Germany, commented, “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 (thrombolysis in cerebral infarction) 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 5x33 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.”