BIOTRONIK is releasing in the United States its PK Papyrus covered coronary stent, the first new device in many years to be used as an emergency therapy for acute coronary perforations. Because so few of these are expected to be used, but are expected to save many lives, the FDA issued a Humanitarian Use Device classification for the technology.

The PK Papyrus features ultra-thin struts that form a single long stent, and an electrospun polyurethane membrane that keeps the pressure of the blood flow mostly contained within itself. The product has been cleared in Europe for about five years now, where it has seen significant use in preventing really bad outcomes.

The stent is available in 17 different sizes and is compatible with 5 French catheters. It is 58% more flexible and has a 23 percent narrower profile than the Graftmaster, a similar competing product from Abbott, according to BIOTRONIK.

Flashback: BIOTRONIK PK Papyrus Stent for Emergency Repair of Coronary Perforations…; BIOTRONIK PK Papyrus for Acute Coronary Artery Perforations Gets European Approval…

Product page: PK Papyrus…


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