Home » FDA Approves Device for Treatment of Acute Coronary Artery Perforations
FDA Approves Device for Treatment of Acute Coronary Artery Perforations
The FDA approved Biotronik’s PK Papyrus Covered Coronary Stent System for treating acute coronary artery perforations or tears in the blood vessels of the heart — the first device approved by the agency for the indication in 17 years.
The device is advanced into the perforated coronary artery vessel using a balloon catheter. Once the stent is implanted, it provides a physical barrier to seal the tear in the artery wall while still allowing blood to flow through the device to the heart muscle.
The agency granted the approval through its humanitarian device exemption pathway. It reviewed real-world survey data from 80 patients who received stents.
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