"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."
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."
The Insight Partners is a one stop industry research provider of actionable intelligence. We help our clients in getting solutions to their research requirements through our syndicated and consulting research services. We specialize in industries such as Semiconductor and Electronics, Aerospace and Defense, Automotive and Transportation, Biotechnology, Healthcare IT, Manufacturing and Construction, Medical Device, Technology, Media and Telecommunications, Chemicals and Materials.
Severity: Warning
Message: count(): Parameter must be an array or an object that implements Countable
Filename: amp/news_details_amp.php
Line Number: 252
Backtrace:
File: /home/smartmarketnews/public_html/application/views/amp/news_details_amp.php
Line: 252
Function: _error_handler
File: /home/smartmarketnews/public_html/application/controllers/Amp_controller.php
Line: 41
Function: view
File: /home/smartmarketnews/public_html/index.php
Line: 315
Function: require_once
Smarter Decisions with Smart News
Smart Market News is committed to getting its readers the latest updates and insights on industries that help in making “smarter” business decisions. With insights and inputs from corporate decision makers, we bring you the stories of adopting innovative solutions and strategies that have been changing the world. Our editorial insights on products, solutions, companies, and adoption of best practices not only help in understanding the markets better, but also prove to be a complete package for your information needs.
media@smartmarketnews.com | sales@smartmarketnews.com
Contact Us