FDA Approves First New Device for Heart Vessel Tears in 17 Years

  Cardiologists have a new tool for handling a rare but potentially life-threatening complication during percutaneous coronary intervention (PCI) procedures. FDA approved Biotronik's PK Papyrus Covered Coronary Stent System as a treatment for tears in the coronary arteries that can occur during heart vessel procedures. The PK Papyrus System is the first device FDA has approved for this indication in 17 years. The device has been CE marked for sale in Europe since 2013. "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," said Bram Zuckerman, MD, director of the Division of Cardiovascular Devices in FDA's Center for Devices and Radiological Health. During PCI, a thin flexible tube with a balloon on the end is inserted into a narrowed coronary artery. Once inserted, the balloon expands the artery, and then a small mesh stent is placed to hold the artery open and increase blood flow to the heart muscle. On very rare occasions, a deep tear occurs in the wall of the treated coronary artery during the PCI procedure. In some coronary perforations, blood can leak out through the tear leading to a life-threatening collection of blood in the sac surrounding the heart. Biotronik has developed ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news