SAN FRANCISCO, July 24, 2018 /PRNewswire/ — CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced 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. The company received U.S. Food and Drug Administration (FDA) clearance to market the mechanical clot removal, or thrombectomy, device in May and is 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,” said 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.1 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.”
The EMBOTRAP II Device is also approved for use in Europe, where more than 5,000 patients have been treated.
Indications for Use
The EMBOTRAP II Revascularization Device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing 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, part of DePuy Synthes Products, Inc., is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.
About the Johnson & Johnson Medical Devices Companies
As the world’s most comprehensive medical devices business, we are building on a century of experience, leveraging science and technology, to shape the future of healthcare. With unparalleled breadth, depth and reach in surgery, orthopaedics and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. Learn more about our latest innovations by visiting: https://www.jnjmedicaldevices.com.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the EMBOTRAP® II Revascularization Device, a next generation stent retriever used to capture and remove life-threatening blood clots from the brain following an ischemic stroke. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes Products, Inc., any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes Products, Inc. any of the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 Impact of Stroke (Stroke statistics). Stroke Treatment. http://www.strokeassociation.org/STROKEORG/AboutStroke/Impact-of-Stroke-Stroke-statistics_UCM_310728_Article.jsp#.Wvycyu4vzIV. Published June 6, 2016.