Biotronik's PK Papyrus Stent for Coronary Perforations Approved Under Humanitarian Device Exemption
September 14, 2018—Biotronik announced FDA approval of the PK Papyrus covered coronary stent system under a humanitarian device exemption for use in the emergency treatment of acute coronary perforations in the United States. PK Papyrus received European CE Mark approval in 2013.
According to the company, PK Papyrus is approved for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter.
The 5-F–compatible covered coronary stent is available in 17 sizes, expanding treatment options and helping avoid the need for emergency coronary artery bypass grafting. The device features an ultrathin, single-stent design and electrospun polyurethane membrane.
Dean Kereiakes, MD, commented in the company's announcement, "In rare cases of a coronary perforation, time is the enemy. The device's superior flexibility and tracking mean that PK Papyrus delivers more like a conventional stent and can treat a perforation more quickly, avoiding further complications. Hospitals need to have this potentially lifesaving device ready for physicians to use." Dr. Kereiakes is an Interventional Cardiologist and Medical Director of The Christ Hospital and Vascular Center in Cincinnati, Ohio.