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Article: Advanced Stent Technologies, Inc. Receives FDA Approval to Commence Feasibility Study on Bifurcation Stent and Delivery System.
- Article from:
- PR Newswire
- Article date:
- November 14, 2001
CopyrightCOPYRIGHT 2001 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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PLEASANTON, Calif., Nov. 14 /PRNewswire/ --
Advanced Stent Technologies, Inc. (AST), a development stage company that is developing innovative stents and delivery systems to treat cardiovascular bifurcation disease, announced today that the US Food and Drug Administration (FDA) has granted conditional approval to AST to commence its feasibility study, entitled "A Non-Randomized Feasibility Study Using the Side-Access Stent (SLK-View(TM)) in Native Coronary Arteries."
The approval was granted on the basis of AST's investigational device exemptions (IDE) application. The approval is for an investigation limited to four institutions and 30 subjects.
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