SUMMIT Trial (U.S. IDE) of the Tendyne Mitral Valve received approval from the FDA

10 April 2018

Tendyne is already in clinical study in Europe and will begin the U.S. trial in 2018.

SUMMIT Trial (U.S. IDE) of the Tendyne Mitral Valve received approval from the FDA
Abbott Structural Heart announced the approval of the SUMMIT Pivotal trial of the Tendyne valve by the FDA. 

“Tendyne is a key part of our plan to provide patients and physicians a complete portfolio of repair and replacement solutions for treating the entire spectrum of mitral and tricuspid valve disease. Tendyne is already in clinical study in Europe and we are on track to begin the U.S. trial in 2018.“ - according to Michael Dale, president of Abbott Structrual Heart. 

About Abbott
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people.

Learn more about Abbott Structural Heart: https://www.vascular.abbott/us/products/structural-heart.html


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