Biotronik said today that it’s launching the PK Papyrus covered coronary stent system for acute coronary artery perforations in the U.S.
When the FDA granted 510(k) clearance last September, the federal safety watchdog touted it as the first such device to win clearance for that indication in 17 years. About 1% of the 800,000 PCIs performed in the U.S. require a covered stent, according to Lake Oswego, N.Y.-based Biotronik, qualifying PK Papyrus for a humanitarian device exemption.
“The availability of PK Papyrus marks a long-overdue advancement in the field of interventional cardiology,” president Ryan Walters said in prepared remarks. “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.”