Neuravi, a company dedicated to improving clinical outcomes for stroke patients, 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, and with the introduction of the EmboTrap II, Neuravi is bringing further innovation to the market. The new device 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 EmboTrap II device is designed to address a broader range of clot lengths, with sizes that are deliverable through an 0.02 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 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.”
“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,” said Eamon Brady, CEO of Neuravi. “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.”
Neuravi will be introducing the system at the 8th annual Congress of the European Society of Minimally Invasive Neurological Therapy in Nice, France, this week.
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 U.S. 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.
Neuravi designs, develops and manufactures innovative medical devices for the treatment of acute stroke. Through its investment in the Neuravi Thromboembolic Initiative (NTI), Neuravi supports collaboration between engineers, clinicians and researchers to deepen the understanding of clot and occlusion dynamics to improve patient outcomes in stroke. More information can be found at www.neuravi.com.
(Source: Business Wire)