USFDA approves new system for acute coronary artery perforations

artery

The USFDA approved Biotronik‘s PK Papyrus Covered coronary Stent System, to treat acute coronary artery perforations, or tears in the blood vessels of the heart.
A coronary artery perforation can arise during percutaneous coronary intervention (PCI) procedures.

However, the German biomedical technology firm’s new system has a balloon-expandable covered coronary stent and delivery system that is advanced into the perforated coronary artery vessel with the help of a balloon catheter. After it is implanted it acts as a barrier to seal the tear in the artery wall, letting blood flow to the heart muscle through the device. This makes it a life-saving procedure that does not require an open-heat surgery.

Real-world survey data from 80 patients who got PK Papyrus stents to treat coronary artery perforations was surveyed an it was found that the stents delivered in the perforation site in 76 out of 80 patients (95%) and it successfully sealed perforation in 73 patients (91.3%).

“An acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel procedures.” said, Dr Bram Zuckerman, FDA’s Centre for Devices and Radiological Health cardiovascular devices division director. “The PK Papyrus Covered Coronary Stent System provides health care 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.”

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