FDA has approved a Biotronik humanitarian device exemption for its PK Papyrus Covered Coronary Stent System which is intended to treat acute coronary artery perforations, or tears in the blood vessels of the heart. This is the first device approved by the agency for this indication in 17 years, a news release says. It provides with a “new treatment option that can seal the perforation in order to stop blood leakage during the procedure and avoid a potentially life-threatening complication or a more invasive surgical procedure,” it says.
The balloon-expandable covered coronary stent and delivery system is deployed into the perforated coronary artery vessel, FDA says. Once implanted, it provides a physical barrier to seal the tear in the artery wall while still allowing blood to flow through the device to the heart muscle. “Successful sealing of a coronary perforation with the PK Papyrus Covered Coronary Stent System can be a life-saving procedure without the need for open-heart surgery,” it says.
The device was approved based on a review of real-world survey data from 80 patients who received it to treat coronary artery perforations. The stents were successfully delivered to the perforation site in 76 of the 80 patients (95%), and the device successfully sealed the perforation in 73 patients (91%). “There were two deaths that occurred during the PCI procedure, and seven patients underwent treatment to drain a fluid collection around the heart,” FDA says. “Post-procedure, in-hospital death occurred in five patients with perforations successfully sealed by PK Papyrus Stents and one patient in which the PK Papyrus Stent did not successfully seal the perforation.”