Biotronik secures CE Mark approval for covered coronary stent system

5 November 2013 (Last Updated November 5th, 2013 18:30)

German firm Biotronik has obtained CE mark approval for its PK Papyrus covered coronary stent system, designed for the treatment of acute coronary artery perforation.

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German firm Biotronik has obtained CE mark approval for its PK Papyrus covered coronary stent system, designed for the treatment of acute coronary artery perforation.

PK Papyrus provides 58% greater flexibility than Abbott's Jostent Graftmaster because of its 'electrospun' membrane developed using 'electrospinning' technology that allows for a proprietary single-layer covered stent design, rather than the traditional 'sandwich technique' used on comparable stents on the market.

In addition, PK Papyrus's single-layer covered stent design, with its 90µm polyurethane membrane, further enables a 24% lower crossing profile compared with Abbott's Jostent Graftmaster.

PK Papyrus is expected to be largely useful for sealing vessel defects in acute situations because of its high-flexibility and a low crossing profile.

The wide size range (diameter 2.5mm-5.0mm, length 15mm-26mm) of the PK Papyrus enables a broad range of vessels to be treated confidently and efficiently.

According to the company, the severe acute perforation is a rare but severe cases have shown up to 20% mortality.

"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."

One of the potential treatments available is to remove the defect by deploying a covered stent over the perforation, but many of existing covered stent designs require large 'French size' (F) guide catheters.

In such emergency situations, switching guide cathethers can cost the physician valuable time, delaying treatments. But PK Papyrus, which is 5 F- and 6 F- compatible, eliminates the need to switch access catheters during these emergency situations.

Biotronik vascular intervention vice president marketing Dr Alexander Uhl said PK Papyrus is a testament to the engineering excellence at 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," Dr Uhl said.

According to GlobalData estimates, the peripheral vascular stents market in EU was valued at $271m in 2012 is expected to grow at a CAGR of 3.8% to reach $352m by 2019.


Image: Biotronik's headquarters in Berlin, Germany. Photo: courtesy of Biotronik SE & Co KG.