Tag: stroke

Stryker’s Trevo™ Retriever becomes first and only device indicated for acute ischemic stroke treatment up to 24 hours in Europe

KALAMAZOO, Michigan, USA, May 7, 2018 /PRNewswire/ — Following the expanded indication in the United States by the Food and Drug Administration (FDA) in February, Stryker’s Trevo Retriever has received CE marking as a front-line treatment for patients experiencing acute ischemic stroke up to 24 hours from symptom onset, increasing the treatment window by 18 […]

FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients

Today, the U.S. Food and Drug Administration permitted marketing of the Viz.AI Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients. A stroke is a serious medical condition that requires emergency care […]

MIVI Neuroscience Begins European Commercialization After Achieving CE Mark Approval Of The R4Q Revascularization Catheter For Ischemic Stroke

EDEN PRAIRIE, Minn., March 29, 2018 /PRNewswire/ — MIVI Neuroscience, Inc. announced today it has received CE Mark approval for the R4Q Revascularization Catheter for the removal of fresh, soft emboli and thrombi in the peripheral and neurovascular systems. The CE Mark approval is a significant accomplishment for MIVI Neuroscience.  This approval enables the […]

Canon Medical Systems’ Aquilion ONE / GENESIS Edition Delivers Full Suite of Acute Stroke Solutions

TUSTIN, Calif.–(BUSINESS WIRE)– The Aquilion ONE™ / GENESIS Edition, capable of imaging the entire brain with a single 640-slice* rotation, covering 16 cm, gives clinicians the potential to diagnose and evaluate acute stroke quickly. The system can also capture both anatomy and function, which provides physicians with additional tools to […]

FDA Permits Marketing of Clinical Decision Support Software for Alerting Providers of a Potential Stroke in Patients

SILVER SPRING, Md., Feb. 13, 2018 /PRNewswire-USNewswire/ — Today, the U.S. Food and Drug Administration permitted marketing of the Viz.AI Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients. A stroke is […]

Stryker’s Wingspan Stent Impresses in Post-Market Study

KALAMAZOO, Michigan, USA, Jan. 25, 2018 /PRNewswire/ — Yesterday the American Heart Association and American Stroke Association updated the ischemic stroke guidelines. The new recommendation expanded the treatment window from six to 16 hours based on overwhelming clinical evidence from the Stryker-sponsored DAWN Trial and confirmed by DEFUSE 3. The guidelines state that […]

ASPIRATION FIRST APPROACH WITH PENUMBRA SYSTEM DEMONSTRATES FAVORABLE OUTCOMES FOR ACUTE ISCHEMIC STROKE

Results of the PROMISE Study Presented at International Stroke Conference LOS ANGELES – January 25, 2018 – Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced results of the company-sponsored PROMISE Study, demonstrating real-world safety and efficacy of the Penumbra System with ACE™68 and ACE™64 […]

MIVI Neuroscience Selects Bob Colloton To Lead Worldwide Commercialization Of Innovative Treatment Solution For Ischemic Stroke

EDEN PRAIRIE, Minn., Jan. 23, 2018 /PRNewswire/ — MIVI Neuroscience, a company dedicated to developing best-in-class treatment solutions to improve clinical outcomes for stroke patients, today announced that Bob Colloton has joined the company’s senior management team as Chief Commercial Officer. Bob brings 27 years of proven experience in medical device sales and market development […]