FDA Approves Biotronik's PK Papyrus Stent for Coronary Perforations

September 27, 2018 — Biotronik recently announced U.S. Food and Drug Administration (FDA) approval of the PK Papyrus covered coronary stent system under Humanitarian Device Exemption for use in the emergency treatment of acute coronary perforations.1,2 PK Papyrus received CE marking in 2013.

Built on Biotronik's ultrathin stent platform, PK Papyrus is the first FDA-approved device for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5 mm in diameter. The covered stent is available in 17 sizes, expanding treatment options and helping avoid the need for emergency coronary artery bypass grafting. PK Papyrus is the only 5 French compatible covered coronary stent available in the United States.

"In rare cases of a coronary perforation, time is the enemy," said Dean Kereiakes, M.D., interventional cardiologist and medical director of The Christ Hospital and Vascular Center, Cincinnati, Ohio. "The device's superior flexibility and tracking means that PK Papyrus delivers more like a conventional stent and can treat a perforation more quickly, avoiding further complications. Hospitals need to have this potentially lifesaving device ready for physicians to use."

The ultrathin, single-stent design and electrospun polyurethane membrane contribute to PK Papyrus' performance. Biotronik's covered stent is 58 percent more flexible3 and has a 23 percent smaller crossing profile compared to Graftmaster.4 The latter has a layered dual-stent design and is the only other covered coronary stent available in the United States.

Fewer than 4,000 percutaneous coronary interventions per year in the United States require a covered stent, classifying PK Papyrus as a Humanitarian Use Device. Biotronik will make the device available to U.S. physicians in 2019.

For more information: www.biotronik.com

References

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 5.0 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. Compared to Jostent Graftmaster 3.0/16 (BIOTRONIK data on file).
4. Compared to Graftmaster 2.8/16 (BIOTRONIK data on file).