Biotronik has launched the PK Papyrus covered coronary stent system in the United States for use in the emergency treatment of acute coronary perforations. PK Papyrus is the first Food and Drug Administration (FDA)-approved device for the treatment of acute perforations in nearly two decades.
In a press release, the company said that the ultrathin strut, single-stent design and unique electrospun polyurethane membrane expands treatment options and is designed to reduce the high rate of adverse outcomes associated with coronary artery perforations. PK Papyrus received CE mark in 2013 and was approved for use by the FDA in late 2018. It is available in 17 sizes and is the only 5Fr compatible covered coronary stent on the US market. Biotronik says its covered stent is 58% more flexible, and has a 23% smaller crossing profile compared to Graftmaster, which has a layered dual-stent design and is the only other covered coronary stent available in the US.
Ryan Walters, president of Biotronik said: “The availability of PK Papyrus marks a long-overdue advancement in the field of interventional cardiology. 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.”