Galway, Ireland — Neuravi, a company dedicated to improving clinical outcomes for stroke patients, today announced commercial availability of the company’s EmboTrap® Revascularization Device for the treatment of acute ischemic stroke in Europe. 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.
Following a stroke, rapid intervention is critical. Recent highly positive multinational clinical trials have demonstrated the benefit of acute endovascular intervention to remove the clot and rapidly restore blood flow to the brain. Physicians use minimally invasive thrombectomy devices, also known as ‘stent-retrievers’, to perform these life-saving procedures.1
The design of the EmboTrap thrombectomy device is informed by extensive research on the wide range of different clot types that cause ischemic stroke. With this foundation of research, the EmboTrap device is engineered to retrieve and retain the clot with a proprietary dual-layer stent-like structure 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.
Ischemic strokes, caused by blockages in vessels supplying blood to the brain, account for 87% of all strokes and are a leading cause of death and disability.2 Approximately one million Europeans3 and 700,000 Americans suffer ischemic strokes each year.4
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. Professor Michael Söderman, Chief of Neuroangiography at Karolinska University Hospital in Sweden, shared his experience with the device during the European Society of Minimally Invasive Neurological Therapy (ESMINT) congress in Nice, France, last month.
“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,” stated Prof. Söderman.
At the 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 percent of patients, with the majority of patients recovering to be able to function independently.5
“The EmboTrap device represents a new wave in innovation for stent retrievers based on clot research and a fuller understanding of the underlying challenge,” said Eamon Brady, Neuravi’s CEO. “We are excited to announce our launch and pleased that, following the compelling clinical data published earlier this year, use of thrombectomy devices for endovascular stroke therapy is on the rise, which should save and improve the lives of many patients.”
The company’s 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 FDA approval.
The EmboTrap Revascularization Device is not currently approved in the U.S., where it is available for investigational use only.
About Neuravi
Based in Galway, Ireland, Neuravi is dedicated to improving clinical outcomes for stroke patients. The company’s initial stroke therapy platform, the EmboTrap Revascularization Device, is CE marked and commercially available in Europe. The device is available for investigational use only in the United States. 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, in order to improve patient outcomes in stroke. Neuravi is led by a team experienced in endovascular device development and global commercialization. More information can be found at www.neuravi.com.
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[1] Furlan AJ. Endovascular therapy for stroke—it’s about time [editorial]. N Engl J Med. 2015.
[2] Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics—2015 update: a report from the American Heart Association. Circulation. 2015 ;e29-322.
[3] Truelsen T, Piechowski-Jozwiak B, Bonita R et al. Stroke incidence and prevalence in Europe: a review of available data. European Journal of Neurology, 2006, 13: 581–598.
[4] CDC, NCHS. Underlying Cause of Death 1999-2013 on CDC WONDER Online Database, released 2015.
[5] Söderman et al, ‘Initial Experience in 42 patients from 2 European Centers’, presented at ESOC 2015 and ESMINT 2015.
Nicole Osmer, +1 (650) 454-0504
nicole@nicoleosmer.com