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Tuesday, 07 July 2020
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The News and Media Division of The Insight Partners
Wednesday, 10 Jun 2020 01:00 pm

MIVI Neuroscience Announces FDA IDE Clinical Study Approval For the MIVI Q Aspiration Catheter

"MIVI looks forward to working with FDA to incorporate the recommended protocol modifications in order to initiate and complete the EVaQ Study in the most rapid manner, and ultimately support a marketing clearance submission," said Bob Colloton, Chief Executive Officer of MIVI.  "We are very excited about the future of the Q Catheter in the United States, building off the success of our devices in Europe."

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MIVI Neuroscience, a developer, and marketer of precision stroke therapy devices utilized by neurointerventionists around the world, announced today that the FDA has determined the company has provided sufficient data to support initiation of a human clinical study of the MIVI Q Aspiration Catheter in the United States.  The EVaQ Study (A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke) will assess the MIVI Q Catheter's ability to remove thrombus / blockages which cause large vessel occlusions (LVO) in the arteries of the brain.

The EvaQ Study is a single arm study with planned patient enrollment in up to 12 clinical centers located in the United States and additional sites in the European Union.  The esteemed principal investigators for the EvaQ study are Dr. Lucas Elijovich of the Semmes Murphy Clinic in Memphis, Tennessee, Dr. Brian Jankowitz of Cooper University Health Care in Camden, NJ, and Professor Christophe Cognard of Purpan University Hospital in Toulouse, France. 

"MIVI looks forward to working with FDA to incorporate the recommended protocol modifications in order to initiate and complete the EVaQ Study in the most rapid manner, and ultimately support a marketing clearance submission," said Bob Colloton, Chief Executive Officer of MIVI.  "We are very excited about the future of the Q Catheter in the United States, building off the success of our devices in Europe."

Tags MIVI Neuroscience FDA Clinical Study Stroke therapy United states Aspiration Catheter

Neha Pandey

Aware of her elements, Neha writes the best articles across industries including electronics & semiconductors, automotive & transportation and food & beverages. Being from the finance background she has the ability to understand the dynamics of every industry and analyze the news updates to form insightful articles. Neha is an energetic person interested in music, travel, and entertainment. Since past 5 years, she written extensively on sectors like technology, finance and healthcare.


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