Medical technology company Biotronik has secured approval from the US Food and Drug Administration (FDA) for the use of its PK Papyrus Covered Stent in emergency acute coronary perforations treatment.
The new coronary stent, which obtained the European CE-Mark in 2013, is said to be the first FDA approved device for this indication in 17 years.
PK Papyrus is a balloon-expandable covered coronary stent and delivery system that can be advanced into the perforated coronary artery vessel using a balloon catheter.
After successful implantation, the stent acts as a physical barrier to close the tear in the artery wall. It also facilitates blood flow to the heart muscle.
The FDA said that sealing of a coronary perforation can be a life-saving procedure, and eliminates the need for open-heart surgery.
FDA Division of Cardiovascular Devices director Bram Zuckerman said: “An acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel procedures.
“The PK Papyrus Covered Coronary Stent System provides healthcare providers with a new treatment option that can seal the perforation in order to stop blood leakage during the procedure and avoid a potentially life-threatening complication or a more invasive surgical procedure.”
During the approval process, the FDA reviewed real-world survey data from 80 patients. The stent was successfully delivered to the perforation site in 95% of the patients, and it successfully sealed the perforation in 91.3% of the cases.
Classified as a humanitarian use device, PK Papyrus can be used for the treatment of native coronary arteries and coronary bypass grafts in vessels with 2.5-5mm diameter.
The stent comes in 17 sizes in order to provide better treatment options and avoid emergency coronary artery bypass grafting.
Biotronik plans to launch the PK Papyrus stent in the US next year, in line with its strategy to gain FDA approval for the complete range of Vascular Intervention products.