For the first time in 17 years, the US Food and Drug Administration today approved a coronary stent system to treat acute coronary artery perforations, which can occur during percutaneous coronary interventions.
The PK Papyrus (Biotronik) covered coronary stent system is available in 17 sizes and is the first 5-French compatible covered stent approved for the treatment of perforations in vessels 2.5 to 5.0 mm in diameter, according to the company.
"An acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel procedures," Bram Zuckerman, MD, director of the FDA's cardiovascular devices division said in a 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," he said.
The FDA approved the balloon-expandable coronary stent system through its humanitarian device exemption pathway. Devices can be designated a humanitarian device if they treat or diagnose a condition affecting fewer than 8000 Americans each year. PK Papyrus received CE marking in Europe in 2013.
Data supporting the benefit of the PK Papyrus device included 80 patients with coronary artery perforations, in whom the stent was successfully delivered in 95% and successfully sealed the perforation in 91.3%, according to the FDA.
Two deaths occurred during PCI and seven patients underwent treatment to drain fluid collected around the heart. Postprocedure in-hospital death was reported in five patients with perforations successfully sealed by the device and in one patient in whom the PK Papyrus stent did not successfully seal the perforation.
The PK Papyrus device should not be used in patients who are not considered candidates for standard percutaneous coronary intervention procedures, such as patients unable to take antiplatelet medications or anticoagulation therapies, those with allergies to contrast media, or those 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 stent system (siloxane-based polyurethane, L-605, and cobalt chromium alloy, including tungsten and nickel), the news release notes.
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Cite this: FDA OKs PK Papyrus Stent for Acute Coronary Artery Perforations - Medscape - Sep 14, 2018.