The PK Papyrus Covered Coronary Stent System (Biotronik) was approved by the US Food and Drug Administration, the agency announced Friday.
The device is the first one in 17 years approved by the FDA to treat acute coronary artery perforations.
“An acute coronary artery perforation is a rare, but potentially life-threatening, complication of heart vessel procedures,” said Bram Zuckerman, MD, director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, in the FDA news release. “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.”
In its news release, Biotronik explained that the ultrathin balloon-expandable PK Papyrus is designed to treat perforations of native coronary arteries and coronary artery bypass grafts (CABG) in vessels 2.5-5.0 mm in diameter. The stent, available in 17 sizes, can help avoid the need for emergency CABG. It has an electrospun polyurethane membrane designed for increased flexibility, the company said.
“In rare cases of a coronary perforation, time is the enemy,” said Dean Kereiakes, MD, interventional cardiologist and medical director of The Christ Hospital and Vascular Center, Cincinnati, Ohio, in the Biotronik news release. “The device's superior flexibility and tracking means that PK Papyrus delivers more like a conventional stent and can treat a perforation more quickly, avoiding further complications. Hospitals need to have this potentially lifesaving device ready for physicians to use.”
The FDA noted that it reviewed data for PK Papyrus through the humanitarian device exemption (HDE) process. This is for devices that treat a condition that affects no more than 8000 individuals in the US per year, the agency said.
PK Papyrus stents were successfully delivered to the perforation site in 76 of 80 patients (95%) whose data from a real-world survey were reviewed by the FDA, and the stent successfully sealed the perforation in 73 patients (91.3%). Two deaths occurred during the percutaneous coronary intervention (PCI) procedure, and 7 patients had fluid drained that had collected around the heart. Post-procedure, 5 patients who had perforations successfully sealed died in the hospital, as did 1 who did not have a successful seal, the FDA said.
The PK Papyrus is contraindicated for patients who are not considered candidates for standard PCI procedures, such as individuals not able to take antiplatelet and/or anticoagulation therapy, patients with allergies to contrast media, and patients with uncorrected bleeding disorders.
Biotronik noted that the PK Papyrus received the CE mark in 2013. The company said it will make the device available to US physicians in 2019.