Cordis' Railway Sheathless Access System Receives FDA Clearance

 

June 12, 2018—Cordis, a Cardinal Health Company, recently received US Food and Drug Administration clearance of the company's Railway sheathless access system. The Railway device is indicated for use in radial artery procedures requiring percutaneous introduction of intravascular devices. Cordis will launch Railway in the United States in the coming months.

According to the company, the Railway device enables direct access to the radial artery with a guiding catheter and eliminates the need for an introducer sheath, reducing the size of the puncture site up to 2 F. Railway can facilitate tracking through complexities in the arm vasculature to overcome various anatomic difficulties during radial procedures.

In April 2017, Cordis received CE Mark approval in Europe, where it is currently marketed in select countries.

 

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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.