FDA Approves Device for Acute Coronary Artery Perforations

MONDAY, Sept. 17, 2018 -- The PK Papyrus Covered Coronary Stent System has been approved by the U.S. Food and Drug Administration to treat acute coronary artery perforations.

"An acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel procedures," Bram Zuckerman, M.D., director of the FDA's Division of Cardiovascular Devices, said in a statement. "The [device] provides health care providers with a new treatment option that can seal the perforation in order to stop blood leakage during the procedure."

The PK Papyrus device is a balloon-expandable covered coronary stent and delivery system, the FDA said. The agency 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 United States, annually.

The device was evaluated in a study of 80 patients who had it implanted. In one instance, the device did not successfully seal the blood vessel tear and the patient later died in the hospital, the FDA said. The device should not be implanted in patients who aren't candidates for percutaneous coronary intervention, nor should it be implanted in patients who are allergic to any material used in the system.

The device is produced by the German firm Biotronik.