FDA clears 1st acute coronary artery perforation stent in 17 years

The FDA said today it approved Biotronik's PK Papyrus covered coronary stent system intended to treat acute coronary artery perforations, touting it as the first such device to win clearance for that indication in 17 years. Coronary artery perforations can occur during percutaneous coronary intervention procedures and can create life-threatening conditions, the FDA said. In some such perforations, blood can leak through the tear and lead to a collection of blood in the sac surrounding the heart, putting a patient's life at serious risk. The newly cleared PK Papyrus is a balloon-expandable covered coronary stent and delivery system which is designed to be advanced into the perforated coronary artery vessel using a balloon catheter to provide a physical barrier to seal the tear and allow...

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