April 15, 2019 — Biotronik began its U.S. commercial launch of the PK Papyrus covered coronary stent system for use in the emergency treatment of acute coronary perforations.[1,2]
Now available in the United States, the PK Papyrus is the first FDA-approved device for the treatment of acute perforations in nearly two decades. More than 800,000 percutaneous coronary intervention (PCI) procedures are performed annually in the U.S. and fewer than 8,000 require a covered stent, classifying PK Papyrus as a Humanitarian Use Device.
The ultrathin strut, single-stent design and unique electrospun polyurethane membrane expands treatment options and is designed to reduce the high rate of adverse outcomes associated with coronary artery perforations.
It is available in 17 sizes and is the only 5 French compatible covered coronary stent on the U.S. market. Biotronik's covered stent is 58 percent more flexible, and has a 23 percent smaller crossing profile compared to Graftmaster, which has a layered dual-stent design and is the only other covered coronary stent available in the U.S.[5,6]
For more information: www.PKPapyrus.com
1. Humanitarian Device. Authorized by Federal law for use in the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5 mm in diameter. The effectiveness of this device for this use has not been demonstrated.
2. Institutional Review Board approval is required for use.
3. Decision Resources Group, Medtech 360, Interventional Cardiology Devices Market Analysis, US 2017.
4. 5F compatible for ø 2.5-4.0 mm.
5. Compared to Jostent Graftmaster 3.0/16 (BIOTRONIK data on file).
6. Compared to Graftmaster 2.8/16 (BIOTRONIK data on file).