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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 ...
The Trifecta (TM) Valve. (Photo: St. Jude Medical, Inc.) Conducted at 31 medical centers in the U.S., Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta ...
By Puyaan Singh (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 ...
The devices are implanted without open heart surgery. The valve delivery system is inserted in the body, the valve is positioned and then implanted inside the diseased aortic valve, and then the delivery system is removed. The catheter-based delivery system can be inserted into the body from one of several sites. [14]
The documents published use the HL7 version 3 Structured Product Labeling (SPL) standard, [1] which is an XML format that combines the human readable text of the product label with structured data elements that describe the composition, form, packaging, and other properties of the drug products in detail according to the HL7 Reference ...
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 CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Researchers from the University of British Columbia have developed a "groundbreaking coating" that could make blood-contacting devices safer. Dr. Jayachandran Kizhakkedathu discusses the benefits.