FDA Oks PK Papyrus stent for acute coronary artery perforati
The U.S. Food and Drug Administration has 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.

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 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).

Read more here: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620603.htm
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