Biotronik Launches PK Papyrus Covered Coronary Stent in the U.S. for Acute Coronary Perforation

VCBeat (WeChat ID: vcbeat) has learned that Biotronik, a globally renowned medical device company, recently announced the U.S. launch of its PK Papyrus covered coronary stent for the treatment of acute coronary perforation.

Biotronik is a medical device company founded in 1999, headquartered in Berlin, Germany. As a leader in cardiac and endovascular medical technology, the company specializes in the development of devices for cardiovascular intervention and electrophysiology therapy. Its portfolio includes innovative products such as cardiac pacemakers, stents, and implantable cardioverter-defibrillators (ICDs), along with supporting remote monitoring service systems, having secured a significant position in the cardiovascular disease market across more than 100 countries and regions worldwide. Reportedly, Biotronik maintains offices in New York City and Oregon in the United States.

Coronary artery perforation is a rare but highly dangerous complication during percutaneous coronary intervention, which can lead to an increased incidence of acute cardiac tamponade and even patient death. The implantation of covered stents can often promptly and effectively control coronary bleeding, prevent or reduce the occurrence of cardiac tamponade, avoid the risks associated with surgical intervention, and lower mortality rates.

PK Papyrus is a balloon-expandable covered coronary stent and delivery system. The device is advanced into the perforated coronary artery using a balloon catheter, similar to those used in percutaneous coronary intervention (PCI) procedures. Once implanted, PK Papyrus provides a physical barrier to seal the tear in the arterial wall while still allowing blood to flow through the device to the myocardium.

It is reported that the product’s design follows the single-stent coverage style of Biotronik’s proprietary Orsiro/PRO-Kinetic platforms and is manufactured using electrospinning technology, with a polyurethane membrane on the stent measuring only 90 μm in thickness (as thin as a butterfly’s wings). Compared to the earlier Jostent Graftmaster stent, the PK Papyrus offers 58% greater flexibility, a lower crossing profile, enhanced deliverability, and comes in 17 sizes to allow for flexible patient-specific selection.

Ryan Walters, President of Biotronik, stated, “PK Papyrus received CE marking as early as 2013. Its launch in the U.S. market will help the company further enhance its portfolio of vascular intervention products.” It is reported that PK Papyrus is the first device approved by the FDA in nearly two decades for the treatment of acute perforations, following the FDA approval of the company’s Orsiro (an ultra-thin strut drug-eluting stent) in February 2019.

(Compiled by Feng Yutong)