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(Reuters) -Abbott Laboratories said on Tuesday the U.S. FDA has approved its heart valve repair device for patients with a potentially fatal heart disease, just months after rival Edwards ...
Advisers to the U.S. Food and Drug Administration on Tuesday backed an approval for Abbott Laboratories' heart valve repair device that is designed for patients who are at risk of complications or ...
Conducted at 31 medical centers in the U.S., Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta valve between 2007 and 2009 as part of a U.S. Food and Drug ...
An artificial heart valve is a one-way valve implanted into a person's heart to replace a heart valve that is not functioning properly (valvular heart disease).Artificial heart valves can be separated into three broad classes: mechanical heart valves, bioprosthetic tissue valves and engineered tissue valves.
[31] [32] It was the first aortic valve device to receive FDA approval, in November 2011 for use in inoperable patients and in October 2012 for use in patients at high surgical risk. [33] The device is effective in improving functioning in patients with severe aortic stenosis.
Edwards introduced the transcatheter heart valve (THV) replacement procedure to U.S. patients unable to undergo open-heart surgery with FDA approval of the SAPIEN transcatheter valve in 2011. [24] The indication was expanded in November 2012 to include patients at a high risk for death or serious complications associated with open-heart surgery ...
The FDA alerted healthcare providers about the potential for clip lock malfunctions with Abbott Laboratories (NYSE: ABT) MitraClip's delivery system to stop heart valve leakage. "These events ...
In January 2012, news broke that vascular device manufacturer AngioDynamics, Inc. would be purchasing Navilyst for $372 million, calling the opportunity "an excellent platform for future revenue and earnings growth, as well as substantial cash flow generation." [5] The purchase was completed on May 22, 2012, valued at $355 million. [6]