Neuravi has received CE mark approval for newly available enhancements to its EmboTrap stent retriever platform, the EmboTrap II revascularisation device. The company will now launch the product in Europe, according to a press release.
The original EmboTrap was fully commercialised in Europe last year. The new device leverages the EmboTrap platform design, which is intendeded 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” 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 have had comparably good results when treating longer occlusions,” says Christian Taschner, 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 introduced the system at the 8th annual Congress of the European Society of Minimally Invasive Neurological Therapy (ESMINT) in Nice, France.
The EmboTrap and EmboTrap II revascularisation devices are available in Europe to treat patients with acute ischaemic stroke. The EmboTrap is currently available for investigational use only in the USA 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 US Food and Drug Administration (FDA) submission for approval to market the device in the USA.