logo
Plus   Neg
Share
Email

Abbott Receives EU Approval For FlexNav Delivery System

Abbott (ABT) said Thursday that it has received CE Mark for the new FlexNav delivery system for the company's Portico transcatheter aortic valve implantation system, enabling marketing authorization in Europe.

Transcatheter aortic valve replacement is a minimally invasive alternative to surgical aortic valve replacement for patients at high or extreme risk for open heart surgery who are diagnosed with severe aortic stenosis, a condition which restricts blood flow through the valve.

While valve technology improvements have helped reduce adverse events and improve patient outcomes, improvements to delivery systems are critical to improving the placement and positioning of the valve.

The Portico Transcatheter Aortic Valve and FlexNav Delivery System are approved for investigational use only in the U.S.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Apotex Corp. recalled all lots of type 2 diabetes medication Metformin hydrochloride in the form of oral film-coated tablets for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels of the Acceptable Daily Intake Limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement. Groupe Renault plans to cut about 14,600 jobs across the world and lower its production capacity. The plan includes almost 4,600 jobs reduction in France, through voluntary retirement and retraining. Amazon said it will convert 125,000 of the 175,000 temporary workers it hired in March amid the coronavirus pandemic, to permanent full-time employees in June. The e-commerce giant had hired the temporary employees in March to meet strong consumer demand amid the lockdown. The job openings were in Amazon's fulfillment centers and its delivery network.
Follow RTT