Restoring the flow
First ischemic stroke patients treated with EMBOTRAP II revascularization device since commercial availability in U.S.
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SAN FRANCISCO—CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced yesterday that the first patients have been treated with its new EMBOTRAP II revascularization device since it became commercially available in the U.S. EMBOTRAP II is a next generation stent retriever used to capture and remove life-threatening blood clots from the brain, following an ischemic stroke, within eight hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
CERENOVUS received U.S. Food and Drug Administration (FDA) clearance to market the mechanical clot removal, or thrombectomy, device in May. The EMBOTRAP II Device is also approved for use in Europe, where more than 5,000 patients have been treated. CERENOVUS will be launching EMBOTRAP II at this week’s Society of NeuroInterventional Surgery (SNIS) 15th Annual Meeting.
“The EMBOTRAP II is an important new device for treating stroke patients and an important advancement in mechanical thrombectomy,” said Andrew DeNardo, MD, an interventional neuroradiologist with Goodman Campbell Brain & Spine, who along with John Scott, MD, Daniel Sahlein, MD, and Richard Paulsen, MD, recently performed thrombectomies with the device at Indiana University Health Methodist Hospital and St. Vincent Hospital in Indianapolis.
The EMBOTRAP II device, with its proprietary dual-layer design, engages and grips stroke-inducing blood clots differently than other stent retrievers, allowing a doctor to maintain engagement and control of the clot with minimal compression during removal. It is indicated for use within eight hours of symptom onset.
“Blood clots can originate in different parts of the body, resulting in different clot types,” noted Dr. Scott. “These different clot types present unique retrieval challenges during mechanical thrombectomy. The design of the EMBOTRAP II device helps minimize these challenges and my early experience has been positive.”
In the ARISE II (Analysis of Revascularization in Ischemic Stroke with EMBOTRAP device) study published earlier this year in the journal, Stroke, neurointerventional stroke physicians restored blood flow in 80 percent of patients treated within three passes, and in about half of patients within a single pass. At the 90-day follow-up, more than two-thirds were functionally independent. The study included 228 patients with large vessel occlusions and moderate to severe neurological deficits.
Stroke strikes nearly 800,000 Americans each year and is a leading cause of disability and the fifth leading cause of death. For stroke patients, 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 occurs.
“While most devices are designed on the characteristics of retrieval, the EMBOTRAP II Device was designed based on extensive research into the characteristics of clot. This led to its innovative dual-layer design, which is unlike any other stent retriever in the U.S. or Europe,” said Daniella Cramp, Worldwide President, CERENOVUS. “CERENOVUS is committed to advancing treatment with evidence-based solutions that help improve outcomes for stroke patients.”
