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

FDA reviewed Biotronik's PK Papyrus System through the humanitarian device exemption process.

Biotronik's PK Papyrus Stent System is a balloon-expandable covered coronary stent and delivery system. The device is advanced into the perforated heart 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.

Biotronik

 

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 a balloon-expandable covered coronary stent and delivery system. The device is advanced into the perforated coronary artery vessel using a balloon catheter, similar to the one used during the PCI procedure. Once the new 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. Successful sealing of a coronary perforation with the PK Papyrus System can be a life-saving procedure without the need for open-heart surgery, FDA noted.

The agency reviewed data for the PK Papyrus System through the humanitarian device exemption process. To qualify for a humanitarian device exemption, a device has to be intended to benefit patients by treating or diagnosing a disease or condition that affects 8,000 U.S. patients a year or fewer.

To support the approval, Biotronik submitted real-world survey data from 80 patients who received the device to treat coronary artery perforations. The stents were successfully delivered to the perforation site in 76 of the 80 patients (95%), and the stent successfully sealed the perforation in 73 patients (91.3%). Two patients died during the procedure, and seven patients had a fluid collection around their heart that had to be drained. After the procedure, six additional patients died in the hospital (five were patients whose perforations had been successfully sealed by the new stent, and one was a patient whose perforation was not successfully sealed by the device).

FDA said patients who are not considered candidates for standard PCI procedures should not be treated with the PK Papyrus System.

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