The FDA has approved the EmboTrap II Revascularization Device for thrombectomy within 8 hours of the appearance of symptoms for patients with ischemic stroke.
Osama Zaidat, MD, Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital
Osama Zaidat, MD
The FDA has approved the EmboTrap II Revascularization Device for thrombectomy within 8 hours of the appearance of symptoms for patients with ischemic stroke, according to Cerenovus, the company developing the device.
Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment with Embotrap II. The approval was based on findings from the ARISE II study, in which those with large-vessel occlusion strokes had high reperfusion rates.
For the primary endpoint of successful reperfusion, 80.2% had a modified treatment in cerebral infarction (mTICI) score of grade 2b to grade 3 within 3 passes (95% CI; 74%—85%; P <.0001). Additionally, 64.8% of patients had mTICI grade 2c-3 (near complete or complete reperfusion) within 3 passes. Final procedural revascularization (mTICI grade 2b to 3) was achieved by 92.5% of patients.
"Mechanical thrombectomy with newer generation devices is increasingly becoming standard treatment for acute ischemic stroke," lead author Osama Zaidat, MD, Stroke and Neuroscience Medical Director of St. Vincent Mercy Hospital, said in a statement. "The EmboTrap II Device with its high first pass rate and its ability to address such a broad range of clot is a crucial step forward for stroke treatment in America."
This study included 228 patients with large vessel occlusions and moderate to severe neurological deficits at 11 US and 8 European sites. The mean age of patients was 68 years and 66.1% had been treated with IV-tPA. The pre-stroke modified Ranking score was 0 for 78% of patients and 1 for 21.6%. The remainder had a score of 2.
After 90 days, 67.3% of patients were functionally independent, with 516% being highly functional. At the 90-day follow-up, all-cause mortality was 9% and the symptomatic intracerebral hemorrhage (sICH) rate was 5.4%.
More than half of patients (51.5%) had mTICI grade 2b to grade 3 reperfusion with EmboTrap II after just 1 pass. Moreover, 40.1% had excellent (mTICI grade 2c-3) reperfusion after the first pass.
"EmboTrap II is the product of deep collaboration between engineers and clinicians to better understand the science of blood clot, what causes them to form and how a mechanical thrombectomy device can interact with them to help improve outcomes," Daniella Cramp, Worldwide President, Cerenovus, said in a statement. "Cerenovus is committed to advancing treatment with evidence-based solutions so that fewer and fewer people are affected by the ravages of stroke."
The Embotrap II was previously approved for use in Europe, where more than 3,000 patients have been treated.