Technology | Cath Lab | April 15, 2019

Biotronik Begins U.S. Launch of PK Papyrus Covered Coronary Stent

Offers a lifesaving solution for the treatment of acute coronary artery perforations

BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.

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.[3] 

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.[4] 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: 

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).

Related Content

Videos | Cath Lab | July 15, 2020
Richard Botto, CVT, RCSA, chief cardiovascular technologist, division of cardiology, cardiac cath lab, offers an over
Videos | Cath Lab | July 13, 2020
The Vieussens’ arterial ring (VAR) is a connection between the conus artery and the left anterior descending (LAD) co
News | Cath Lab | July 06, 2020
July 6, 2020 — Black patients who undergo percutaneous coronary intervention (PCI) are at an increased risk for major
TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.