BIOTRONIK announces CE mark for PK Papyrus covered coronary stent for acute coronary artery perforation

PK Papyrus provides 58% greater flexibility and a 24% reduced crossing profile compared to Abbott’s Jostent Graftmaster

BUELACH, Switzerland, November 5, 2013 – BIOTRONIK announced today that the PK Papyrus covered coronary stent system has received CE mark for the treatment of acute coronary artery perforation.

PK Papyrus boasts 58% greater flexibility than Abbott’s Jostent Graftmaster due to its innovative “electrospun” membrane. The enhanced “electrospinning” technology allows for a proprietary single-layer covered stent design, rather than the traditional “sandwich technique” used on comparable stents on the market. The single-layer covered stent design, with its 90μm polyurethane membrane, further enables a 24% lower crossing profile in comparison to Abbott’s Jostent Graftmaster, combining high flexibility and a low crossing profile for exceptional deliverability while sealing vessel defects in acute situations.

Severe acute perforation is a rare but catastrophic event that has shown up to 20% mortality1. One potential treatment is to exclude the defect by deploying a covered stent over the perforation. Many current covered stent designs require large 'French size' (F) guide catheters. Switching guide cathethers can cost the physician valuable time, delaying treatments. PK Papyrus is 5 F- and 6 F- compatible, thereby eliminating the need to switch access catheters during these emergency situations.

Prof. Georg Nickenig, University Hospital Bonn, commented: “In acute situations when there is a vessel perforation, I need a stent that is highly effective and has optimum deliverability. With PK Papyrus, I am confident that, if such a situation arises, I have a stent that is straight-forward to introduce into the artery with a flexibility that means simplified placement.”

While PK Papyrus is based on the same proven Orsiro/PRO-Kinetic Energy stent platform, the wide size range (diameter 2.5-5.0 mm, length 15-26 mm) enables a broad range of vessels to be treated confidently and efficiently.

“PK Papyrus is a testament to the engineering excellence at BIOTRONIK,” said Dr. Alexander Uhl, Vice President Marketing, Vascular Intervention, BIOTRONIK. “The application of this electrospinning technology to the already highly deliverable BIOTRONIK Orsiro/PRO-Kinetic Energy stent platform has allowed us to introduce a novel product to the market that will enable physicians to treat patients in emergency situations quickly and safely.”

As one of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5600 employees. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®, the world’s first 4 F-compatible 200 mm peripheral stent, Orsiro, the industry’s first hybrid drug-eluting stent, and the world’s first implantable cardioverter-defibrillators and heart failure therapy devices with ProMRI® technology. This year BIOTRONIK celebrates its 50th anniversary.

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1 Rogers, J.H. and Lasala, J.M. 2004. Coronary artery dissection and perforation complicating percutaneous coronary intervention. Journal of Invasive Cardiology, 16(9).

Manuela Schildwächter
Global Communications Manager
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12359 Berlin
Tel. +49 (0) 30 68905 1466