As the first new treatment option in the indication in 17 years, Biotronik’s sheathed emergency stent, used to seal off perforations in the blood vessels of the heart without performing open bypass surgery, was approved by the FDA.
The PK Papyrus rescue system is designed to be used on the rare occasions when coronary arteries are torn open during the placement of stents or during other minimally invasive procedures.
Biotronik’s stent is inserted in a similar fashion and is guided by a catheter to the heart vessel, where it is expanded with a balloon at the site of the tear, allowing an electrospun polyurethane membrane to seal off the leaking artery from the inside.
The company estimates that fewer than 4,000 percutaneous interventions annually see this kind of complication, out of the more than 800,000 coronary procedures performed each year. The Papyrus system was approved under a humanitarian device exemption from the FDA, which granted the green light after considering real-world survey data involving 80 patients.
The device successfully sealed the perforations in over 91% of those cases, though five patients later died, and seven required subsequent treatment to drain fluids collected around the heart.
Berlin-based Biotronik commercially launched the device in the U.S. in early April, offering 17 different sizes. The company describes the Papyrus’ single-stent design as more flexible and having a smaller crossing profile compared with Abbott’s Jostent Graftmaster covered stent—the only other similar device authorized in the U.S., with a PTFE membrane sandwiched between two surgical steel stents.