The U.S. Food and Drug Administration today approved a device intended to treat acute coronary artery perforations, or tears in the blood vessels of the heart. The PK Papyrus Covered Coronary Stent System is the first device approved by the FDA for this indication in 17 years.

“An acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel procedures,” said Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “The PK Papyrus Covered Coronary Stent System provides health care providers 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.”

A coronary artery perforation can occur during Percutaneous Coronary Intervention (PCI) procedures. PCI is used to treat heart blood vessels (coronary arteries) narrowed by the build-up of plaque (fatty deposits and scar tissue). During PCI, a thin flexible tube with a balloon on the end is inserted into a narrowed coronary artery. Once inserted, the balloon expands the artery, and then a small mesh device, known as a stent, is placed to hold the artery open and increase blood flow to the heart muscle. On very rare occasions, a deep tear occurs in the wall of the treated coronary artery during the PCI procedure. The tear is referred to as an acute coronary artery perforation. In some coronary perforations, blood can leak out through the tear leading to a life-threatening collection of blood in the sac surrounding the heart.

The PK Papyrus Stent System is a balloon-expandable covered coronary stent and delivery system. The device is advanced into the perforated coronary artery vessel using a balloon catheter, similar to the one used during the PCI procedure. Once the PK Papyrus Stent is 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.

The FDA reviewed data for the PK Papyrus System through the humanitarian device exemption process. A Humanitarian Use Device is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects not more than 8,000 individuals in the U.S. per year.

The FDA reviewed real-world survey data from 80 patients who received PK Papyrus Stents to treat coronary artery perforations. PK Papyrus Stents were successfully delivered to the perforation site in 76 of the 80 patients (95 percent), and the device successfully sealed the perforation in 73 patients (91.3 percent). There were two deaths that occurred during the PCI procedure, and seven patients underwent treatment to drain a fluid collection around the heart. 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.

The PK Papyrus System is contraindicated for patients who are not considered candidates for standard PCI procedures, such as individuals not able to take anti-platelet and/or anticoagulation therapy (“blood thinners”), patients with allergies to contrast media, and patients with uncorrected bleeding disorders. The device is also contraindicated for patients with a known allergy or hypersensitivity to amorphous silicon carbide or any other compound of the PK Papyrus Covered Coronary Stent System (Siloxane-based Polyurethane, L-605, and cobalt chromium alloy, including tungsten and nickel). Patients should discuss other contraindications with their health care providers. FDA granted the humanitarian device exemption to Biotronik.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.