Neuravi Launches EmboTrap Revascularization Device in Europe

October 1, 2015—Neuravi announced European commercial availability of the company’s EmboTrap Revascularization Device for the treatment of acute ischemic stroke. The device will be marketed through the sales and distribution network the company has established in Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and Switzerland.

According to Neuravi, the EmboTrap device is designed with a dual-layer stent-like structure to retrieve and retain clot, while restoring blood flow to the brain. The device’s integrated distal protection zone is designed to reduce the risk of fragments of clot dislodging during retrieval, which could cause additional harm to the patient.

Neuravi advised that the EmboTrap has been used extensively to treat patients with large vessel ischemic stroke during clinical evaluation and in an initial phased launch in Europe.

Prof. Michael Söderman, MD, shared his experience with the device during the 7th ESMINT Congress of the European Society of Minimally Invasive Neurological Therapy held September 11–15, in Nice, France. Prof. Söderman is Chief of Neuroangiography at Karolinska University Hospital, in Stockholm, Sweden.

At the ESMINT Congress, Prof. Söderman presented data from a case series evaluating use of the EmboTrap device in 42 stroke patients at two European centers. In the series, treatment with the device restored significant blood flow in 86% of patients, with the majority of patients recovering to be able to function independently. In the company’s press release, Prof. Söderman commented, “At Karolinska, we are using the EmboTrap to treat the majority of our stroke patients. It is our first choice for middle cerebral artery occlusions because it is highly deliverable, and we have found the device to be very effective in removing clots in just one to two passes. It is also quite flexible, which is important both for getting to the clot quickly and helps in being gentle on the cerebrovasculature during removal.”

Neuravi also announced that its ARISE II clinical trial will begin enrolling patients this year at select centers in the United States and Europe. The trial will gather data to support the use of the EmboTrap and to seek US Food and Drug Administration approval. In the United States, the EmboTrap revascularization device is not currently approved and is available for investigational use only.