Biotronik Launches PK Papyrus Covered Coronary Stent in the United States

 

April 10, 2019—Biotronik announced the United States commercial launch of its PK Papyrus covered coronary stent system for use in the emergency treatment of acute coronary perforations.

The company stated that the device features an ultra-thin strut, single-stent design and electrospun polyurethane membrane. It is designed to reduce the high rate of adverse outcomes associated with coronary artery perforations. It is available in 17 sizes and is 5-F compatible.

In September 2018, Biotronik announced FDA approval of PK Papyrus under a humanitarian device exemption for use in the emergency treatment of acute coronary perforations in the United States. PK Papyrus received European CE Mark approval in 2013. PK Papyrus is approved for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter.

 

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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.