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The IRB Information Guide provides information to support facilities in obtaining IRB approval to start using the PK Papyrus Covered Coronary Stent System.
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IRB INFORMATION GUIDE
PK Papyrus Humanitarian Use Device Institutional Review Board Information
The PK Papyrus Covered Coronary stent is FDA approved and BIOTRONIK will commercially launch PK Papyrus in 2019.
We recommend interested hospitals plan IRB submission for PK Papyrus in early 2019. The IRB Information Guide provides information to support facilities in obtaining IRB approval and provide details of the applicable FDA regulations associated with the use of the PK Papyrus Covered Coronary Stent System Humanitarian Use Device. The IRB Information Guide can be downloaded below.
Facilities should evaluate whether a local or central IRB may be used to obtain approval for the use of the PK Papyrus HUD at the facility. Further details are available in the FDA Guidance Document “Humanitarian Device Exemption (HDE) Regulation: Questions and Answers. Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff” Issued July 8, 2010.
For IRB-related questions, contact us:
- 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 5.0 mm in diameter. The effectiveness of this device for this use has not been demonstrated. Institutional Review Board (IRB) full board review and approval is required prior to use. BIOTRONIK is required to verify adequate IRB approval documentation prior to product shipment. IRB continuing renewal maintenance is required.