September 28, 2016 — Neuravi recently announced Conformité Européenne (CE) Mark approval and launch of the company’s newly available enhancements to the EmboTrap stent retriever platform, the EmboTrap II Revascularization Device.
Adoption of endovascular stroke therapy procedures for the treatment of acute ischemic stroke continues to grow significantly following compelling data from multiple large-scale randomized trials last year. These trials confirmed the value of using stent retriever thrombectomy to rapidly clear occlusive clots from large cerebral vessels.
The novel EmboTrap was fully commercialized in Europe last year. The EmboTrap II leverages the EmboTrap platform design, engineered to trap and remove a variety of clot types and rapidly re-establish flow, with an integrated fragment protection zone. The new device is designed to address a broader range of clot lengths, with sizes that are deliverable through a 0.021-inch 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,” said Christian Taschner, M.D., professor of radiology, University of Freiburg, Germany. “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 clots inside and also makes it quite flexible, which is important when removing clots from the arteries of the brain.”
Neuravi introduced the system at the 8th annual Congress of the European Society of Minimally Invasive Neurological Therapy, Sept. 8-10 in Nice, France.
The EmboTrap and EmboTrap II revascularization devices are available in Europe to treat patients with acute ischemic stroke. The EmboTrap is currently available for investigational use only in the United States under the ARISE II clinical trial, an international clinical trial assessing safety and effectiveness in the United States and Europe. Data from the trial will support a U.S. Food and Drug Administration (FDA) submission for approval to market the device in the United States.
For more information: www.neuravi.com