The FDA approved a new emergency stent device to treat perforations in the blood vessels of the heart, the agency’s first new treatment option in the indication in 17 years.
Deep tears in coronary arteries can occur on rare occasions during percutaneous interventions, where stents are inserted via a catheter to expand narrowed vessels to increase blood flow to the heart.
To stop blood from leaking out to the area surrounding the heart, Biotronik’s PK Papyrus covered, ultrathin, balloon-expandable coronary stent system is inserted in a similar procedure. It provides a physical barrier with a polyurethane membrane that seals the tear from inside the artery, avoiding the need for open-heart surgery.
“Perforation is very uncommon, but physicians need to be fully prepared for this emergency event,” said Marlou Janssen, president of Biotronik, which estimated fewer than 4,000 interventions per year require rescue with a covered stent. “It’s unacceptable that this critical care area has seen no innovation in nearly two decades.”
For the approval, the FDA reviewed the PK Papyrus system under the humanitarian device exemption process, intended for conditions that affect fewer than 8,000 patients annually in the U.S. The agency considered real-world survey data from 80 patients who received PK Papyrus stents, with successful delivery reported in 76, or 95%, and successful sealing of the perforation in 73 patients, or 91.3%.
Two deaths occurred during the original percutaneous coronary intervention, with seven patients undergoing treatment to drain fluids collected around the heart, the FDA said. Five patients died in the hospital after their perforations were successfully sealed, while one patient died who did not have a successful procedure.
Available in 17 sizes, PK Papyrus previously received a CE mark in 2013. Biotronik plans to make the system available to U.S. physicians next year.
The Berlin-based company received its first FDA approval of a coronary stent in February 2017 for its bare-metal PRO-Kinetic Energy system. The cobalt-chromium alloy stent can treat coronary artery disease in vessels 2.25 to 4 mm in diameter and up to 31 mm long. It is coated with a layer of silicon carbide to lessen the release of metal ions into the surrounding tissue. Before that, the company received a 2015 approval for its Astron stent to treat peripheral artery disease.