BIOTRONIK Announces US Launch of PK Papyrus Covered Coronary Stent

Posted on April 11, 2019 by Medtech[y] Staff

Initially approved in by the FDA in late 2018, BIOTRONIK announced that they are launching their PK Papyrus covered coronary stent system in the US. The stenting system is the first FDA approved device for the treatment of acute coronary artery perforations in almost two decades.

There are more than 800,000 percutaneous coronary intervention procedures done annually in the US and less than 8,000 require a covered stent, which is why the Papyrus will be classified as a Humanitarian Use Device. The PK Papyrus will be available in 17 sizes and will be the only 5 French compatible covered coronary stent on the US market.

"The availability of PK Papyrus marks a long-overdue advancement in the field of interventional cardiology," said Ryan Walters, President of BIOTRONIK, Inc. "Clinicians can now rely on a low-profile covered stent during critical cardiac emergencies. In situations where every second counts, physicians can trust PK Papyrus to deliver quickly. BIOTRONIK's covered stent is designed to save more lives and to help avoid emergency bypass surgeries, which come with increased risk for patients and can be costly for hospitals. This is innovation that matters for hospital administrators, physicians and their patients, who deserve the best outcomes."

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