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 blood to flow through the device.
The FDA said it reviewed the PK Papyrus through a humanitarian device exemption. Data supporting the approval included a real-world survey of 80 patients who received the system to treat coronary artery perforations, which indicated that the system was successfully delivered in 95% of patients and resulted in successful seals in 91.3% of the patient population.
Two deaths were reported that occurred during the PCI procedure, and seven patients underwent treatment to drain fluid collection around the heart, the FDA said in its release. A total of five post-procedure, in-hospital deaths were reported in patients with successfully sealed perforations.
The federal watchdog said that the PK Papyrus system is contraindicated for patients not considered candidates for standard PCI procedures, including patients on anti-platelet or anticoagulation therapy, and for patients with known allergies or hypersensitivity to materials in the stent.
Last month, Biotronik said that it won an exclusive U.S. distributorship for InfoBionic’s MoMe Kardia external cardiac diagnostic monitor.