New FDA-Approved Stent System Fixes Coronary Artery Perforation


Today, FDA have released an article about an updated device for detecting heart diseases / Photo Credit via Pixabay


In its official website, the Food and Drug Administration (FDA) recently posted an article about its approval of a device that has the capability of treating acute coronary artery perforations, commonly known as tears in the blood vessels of the heart. The device, called the PH Papyrus Covered Coronary Stent System, is the first one of its kind to be approved by the FDA in more than 17 years.

Bram Zuckerman, M.D., the director of the Division of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, stated that although rare, acute coronary artery perforation may prove to be fatal to the people who have them but have no means to treat them. He went on to explain that the PK Papyrus Covered Coronary Stent System can give much-needed support and a new avenue of treatment for the relevant health care providers all over the world. The device works by sealing the perforation to stop the life-threatening blood leakage during a vital procedure of the patient. This gives immense help to the patient, as it prevents further complications and more invasive procedures that might be needed later on.

The perforation usually occurs during the percutaneous coronary intervention (PCI) procedure due to unforeseen circumstances or the lack of experience by the surgeon. PCI is generally done to treat patients who have a buildup of plaque in their heart blood vessels.

The PK Papyrus Stent System is a balloon-expandable, covered coronary stent and delivery system that can be used by the doctors to go through the perforated vessel using a special balloon catheter. Once it reaches its destination, the device provides a more physical barrier to prevent further leakage yet still allow blood to properly circulate.

The hope is that with this recent FDA approval, the new device can be supplied to large hospitals all over the country so that it can be used to save lives.