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FDA OKs Device for Treatment of Acute Coronary Artery Perforations

The FDA has approved a device intended for the treatment of acute coronary heart perforation, a rare, but potentially life-threatening complication of heart vessel procedures.

The US Food and Drug Administration (FDA) has approved Biotronik's Papyrus Covered Coronary Stent System device, which is intended to treat acute coronary artery perforations (tears in the blood vessels of the heart).

“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 a recent statement. “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 balloon-expandable covered coronary stent and delivery system, the PK Papyrus Stent System is a device that is placed into the perforated coronary artery vessel through use of a balloon catheter. Once in place, the device seals the tear in the artery wall by supplying a physical barrier while still allowing blood to flow to the heart muscle through the device. This function with the device can be life-saving all the while avoiding open-heart surgery.

The device was reviewed by the FDA through the humanitarian device exemption process and real-world survey data that included 80 patients who were administered the PK Papyrus Stents to treat coronary artery perforations.

In 76 of the 80 patients (95%), the PK Papyrus Stents were successfully delivered to the perforation site. In 73 patients (91.3%), the device successfully sealed the perforation. Seven patients received treatment to drain a fluid collection around the heart, and only 2 deaths occurred during the Percutaneous Coronary Intervention (PCI) procedure.

In-hospital death occurred in five patients with perforations successfully sealed by PK Papyrus Stents post-procedure. One in-hospital death occurred in 1 patient in who the perforation was not successfully sealed by the PK Papyrus Stent.

For patients not considered candidates for standard PCI procedures, such as those unable to receive anti-platelet and/or anticoagulation therapy (“blood thinners”), those with allergies to contrast media, and those patients with uncorrected bleeding disorders the PK Papyrus System is contraindicated.

For those 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), the device is also contraindicated.

Humanitarian device exemption was also granted by the FDA to Biotronik.