New Study Shows Use of EMBOTRAP® Device Clot Retriever During Treatment of Stroke Yields Positive Rates of Revascularization
ARISE II Clinical Trial Results Published in Stroke Journal

Gothenburg, Sweden – May 16, 2018 –EMBOTRAPÒ Device, a device designed to remove clots from the brain following an ischemic stroke, demonstrated high success rates in restoring blood flow and patients achieved high rates of functional independence, according to ARISE II (Analysis of Revascularization in Ischemic Stroke with EMBOTRAP® Device), a new clinical trial published in Stroke [Journal].

According to the European Journal of Neurology, the number of stroke events in Europe is projected to rise from 1.1 million in 2000 to 1.5 million per year by 2025, primarily due to the aging population¹. Strokes globally strike 15 million people² each year, are a leading cause of disability and the second leading cause of death across Europe³. For the 1 in 6 who will have a stroke each year⁴ the difference between life and death, and functional independence or disability, is tied to timely restoration of blood flow to the oxygen-starved brain after a stroke event occurs. In the European Union alone, the economic burden of stroke is estimated at €62 billion annually².

In the ARISE II study, neurointerventional stroke physicians were able to restore blood flow in 80 per cent of patients treated with EMBOTRAP® Device within three passes (with a reperfusion grade of mTICI ≥2b). By the end of the procedure, vessels were opened in 93 percent of patients. In addition, successful reperfusion was achieved with just a single pass in more than half the patients. At the 90-day follow-up, 67 percent were functionally independent. Overall, the study successfully met the prespecified endpoint.

“I believe that the ARISE II results demonstrate that EMBOTRAP® can provide an effective treatment option for stroke patients with a large vessel occlusion. In particular, the high rates of complete revascularization, with over half achieving successful reperfusion in a single pass” described Tommy Andersson, MD, PhD, Neurosurgeon and Neuroradiologist at the Karolinska University Hospital, Stockholm. “I have been using EMBOTRAP® for a number of years, for the effectiveness and clinical outcomes, something I relate to the design of EMBOTRAP® and how it functions in trapping the clot.”

ARISE II was a multicenter clinical study of 228 patients, conducted to assess the safety and effectiveness of the EMBOTRAP® Device, a next-generation stent retriever designed to retrieve a broad range of clot types. Patients eligible for the study had large vessel occlusions (LVO) and moderate to severe neurological deficits within eight hours of symptom onset.

“We were honored to work with an eminent team of international physicians committed to advancing stroke therapy,” said Mairsíl Claffey, Head of Clinical and Regulatory, Ischemic stroke for CERENOVUS. “We are pleased that both the ARISE II results, and the physician feedback during the study reflect positively on the EMBOTRAP® Device design and the extensive clot research which forms its foundation. This research underpins our commitment to developing evidence-based stroke solutions to enhance patient care.”

The EMBOTRAP® Device platform was developed by Neuravi Limited. CERENOVUS acquired Neuravi Limited in April 2017.

CERENOVUS submitted the ARISE II study data as part of its application to the U.S. Food and Drug Administration (FDA) for marketing clearance of EMBOTRAP® Device in the United States. The device is already approved for use in Europe, where more than 3,000 patients have been treated.

References

1. Stop Afib. (2009). How Can We Avoid a Stroke Crisis? [Online] https://www.stopafib.org/newsitem.cfm/NEWSID/221/Action%20for%20Stroke%20Prevention/risk%20of%20stroke%20crisis%20in%20Europe%20from%20atrial%20fibrillation Last accessed May 9, 2018.
2. The Economist Intelligence Unit (2016) Addressing the global stroke burden. [Online]. https://perspectives.eiu.com/sites/default/files/Addressingtheglobalstrokeburden_0.pdf. Last accessed May 2, 2018.
3. Stroke Association (2013) Stroke Statistics. [Online] http://www.thepossibilities.co.uk/assets/downloads/stroke-statistics.pdf. Last accessed May 9, 2018.
4. World Stroke Campaign (2018) The Facts Behind “1 in 6”. [Online] http://www.worldstrokecampaign.org/learn/the-facts-behind-1-in-6.html. Last accessed May 8, 2018.