PK(Pharmacokinetic) Papyrus Covered Coronary Stent System

The FDA has approved the PK Papyrus Covered Coronary Stent System for use in patients being treated for acute perforations of native coronary arteries and coronary bypass grafts in vessels ranging from 2.5 to 5.0 mm in diameter, under a Humanitarian Device Exemption (HDE #H170004). Methodist Dallas Medical Center will use this device for treating the above-described patient population.

Inclusion criteria

• Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter

Exclusion criteria

• Patients in whom antiplatelet agents or anticoagulation therapy is contraindicated.
• Patients with a known 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 treatment-related occlusion of vital coronary artery side branches.
• Uncorrected bleeding disorders.
• Allergy to contrast media.