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May 22, 2018

J&J’s Cerenovus gets FDA approval for stent retriever device

Johnson & Johnson (J&J) subsidiary Cerenovus has received approval from the US Food and Drug Administration (FDA) for its EMBOTRAP II Revascularization Device to treat ischemic stroke.

Johnson & Johnson (J&J) subsidiary Cerenovus has received approval from the US F ood and Drug Administration (F DA) for its EMBOTRAP II Revascularization Device to treat ischemic stroke.

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The device has been designed as a stent retriever that can be used to capture and remove life-threatening blood clots within the neurovasculature of the brain after a stroke.

It restores blood flow quickly and requires minimal compression, in turn avoiding further complications.

“The F DA decision comes after a review of the ARISE II study performed to evaluate the EMBOTRAP II device in 228 patients with large vessel occlusions and moderate to severe neurological deficits.”

The mechanical thrombectomy device is approved for use within eight hours of onset of stroke symptoms in patients not eligible for intravenous tissue plasminogen activator (IV t-PA) or failed IV t-PA therapy.

Cerenovus worldwide president Daniella Cramp said: “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.

Cerenovus is committed to advancing treatment with evidence-based solutions so that fewer and fewer people are affected by the ravages of stroke.”

The F DA decision comes after a review of the ARISE II study performed to evaluate the EMBOTRAP II device in 228 patients with large vessel occlusions and moderate to severe neurological deficits.

Data revealed restoration of blood flow in 80% of subjects treated within three passes and in around 50% of those within a single pass. More than two-thirds of the participants were found to be functionally independent at 90-day follow-up.

The device also secured the European regulatory approval, where it has been used to treat more than 3,000 patients.

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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