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  1. Device Approvals, Denials and Clearances

PK Papyrus Covered Coronary Stent System - H170004

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This is a brief overview of information related to the FDA's approval to market this product. See the links below to the Summary of Safety and Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: PK Papyrus Covered Coronary Stent System
HDE Applicant: Biotronik, Inc.
Address: 6024 Jean Road; Lake Oswego, OR 97035
Approval Date: September 14, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf17/H170004A.pdf

What is it? The PK Papyrus Covered Coronary Stent System is a balloon-expandable covered stent that is advanced into a coronary artery using a balloon catheter delivery system. The stent is made from cobalt-chromium metal alloy and covered with a polyurethane membrane. The device is intended to treat coronary artery perforations, which are tears in heart blood vessels.

How does it work? The PK Papyrus Covered Coronary Stent delivery balloon catheter is positioned at the site of a coronary artery perforation. The balloon is inflated, which expands the covered stent and presses it against the coronary artery wall to seal the perforation and allow normal blood flow to the heart muscle. The stent remains permanently implanted within the coronary artery.

When is it used? The PK Papyrus Covered Coronary Stent System is used to seal coronary artery perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter. A coronary artery perforation is a rare, life-threatening complication of percutaneous coronary intervention (PCI) procedures that are performed to treat heart arteries that are narrowed by plaques (cholesterol deposits and scar tissue). Coronary artery perforations can result in bleeding into the sac that surrounds the heart, which can compress the heart and interfere with its pumping function.

What will it accomplish? The PK Papyrus Covered Coronary Stent System is intended to be permanently implanted at the site of a coronary artery perforation, providing a physical barrier that prevents further bleeding from the perforation.

In a voluntary survey of 80 patients who received the PK Papyrus Stent implantation to treat coronary artery perforation, the device was successfully delivered to the perforation site in 76 of 80 partients (95.0%), and the perforations were successfully sealed in 73 of 80 patients (91.3%).

When should it not be used? The PK Papyrus Covered Coronary Stent System should not be used in:

  • Patients who are not able to take antiplatelet agents or anticoagulation therapy.
  • Patients with an allergy or hypersensitivity to amorphous silicon carbide or any other compound of the system (siloxane-based polyurethane, L-605 cobalt chromium alloy including tungsten and nickel).
  • Lesions that cannot be reached or treated with the system.
  • Lesions with threatened or abrupt closure during attempted pre-dilation prior to stent implantation.
  • Risk of blockage of vital coronary artery side branches by the PK Papyrus Covered Coronary Stent.
  • Patients with uncorrected bleeding disorders.
  • Patients with an allergy to contrast media.

Additional information (including warnings, precautions, and adverse events):