We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us

Download Mobile App




Stent System Treats Acute Coronary Artery Perforations

By HospiMedica International staff writers
Posted on 25 Sep 2018
Print article
Image: An innovative cardiac stent saves lives by sealing PCI perforations (Photo courtesy of Biotronik).
Image: An innovative cardiac stent saves lives by sealing PCI perforations (Photo courtesy of Biotronik).
An innovative device helps resolve acute coronary artery perforations, a rare outcome of percutaneous coronary intervention (PCI) procedures.

The Biotronik (Buelach, Switzerland) PK Papyrus System is a balloon-expandable covered coronary stent--composed of siloxane-based polyurethane, L-605, and cobalt chromium alloy--and a delivery system. The stent is designed to be advanced into the required coronary artery vessel using a balloon catheter to the perforation site. Once deployed, the stent provides a physical barrier to seal the tear in the artery wall, while still allowing blood to flow through it to the myocardium. The PK Papyrus System is intended for vessels 2.5-5.0 mm in diameter, and is available in 17 sizes.

The system was approved by the U.S. Food and Drug Administration (FDA) based on real-world survey data from 80 patients who received the PK Papyrus Stent for a coronary artery perforation. The stents were successfully delivered to the perforation site in 95% of patients, successfully sealing it in 91.3%. There were two deaths during the PCI procedure itslef, and seven patients underwent treatment to drain pericardial fluids. Post-procedure, in-hospital death occurred in five patients with perforations successfully sealed, and in one patient in which the PK Papyrus Stent did not seal the perforation.

“Perforation is very uncommon, but physicians need to be fully prepared for this emergency event. It's unacceptable that this critical care area has seen no innovation in nearly two decades,” said Marlou Janssen, President of Biotronik. “Biotronik saw a need, rose to the occasion, and invested in bringing this stent to the United States. We made this decision because patient care is paramount, and we are committed to helping physicians and hospitals save lives and improve patient outcomes.”

“An acute coronary artery perforation is a rare but potentially life-threatening complication of heart vessel procedures,” said Bram Zuckerman, MD, director of the division of cardiovascular devices at the FDA Center for Devices and Radiological Health (CDRH). “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.”

The PK Papyrus System is contraindicated for patients not suited for standard PCI procedures, such as those unable to take anti-platelet and/or anticoagulation therapy, patients with allergies to contrast media, patients with uncorrected bleeding disorders, and those with a known allergy or hypersensitivity to amorphous silicon carbide or to any other compound of the PK Papyrus system, including tungsten and nickel.

Gold Member
STI Test
Vivalytic Sexually Transmitted Infection (STI) Array
Gold Member
12-Channel ECG
CM1200B
Silver Member
Wireless Mobile ECG Recorder
NR-1207-3/NR-1207-E
New
Patient Monitor
CMS9100PLUS

Print article

Channels

Critical Care

view channel
Image: Researchers have developed a novel risk score for cardiovascular complications after bone marrow transplant (Photo courtesy of 123RF)

Novel Tool Predicts Cardiovascular Risks after Bone Marrow Transplantation

Every year, thousands of people undergo bone marrow transplants to potentially cure serious diseases like leukemia, lymphoma, and immune deficiency disorders. While these transplants can be lifesaving,... Read more

Patient Care

view channel
Image: The newly-launched solution can transform operating room scheduling and boost utilization rates (Photo courtesy of Fujitsu)

Surgical Capacity Optimization Solution Helps Hospitals Boost OR Utilization

An innovative solution has the capability to transform surgical capacity utilization by targeting the root cause of surgical block time inefficiencies. Fujitsu Limited’s (Tokyo, Japan) Surgical Capacity... Read more

Health IT

view channel
Image: First ever institution-specific model provides significant performance advantage over current population-derived models (Photo courtesy of Mount Sinai)

Machine Learning Model Improves Mortality Risk Prediction for Cardiac Surgery Patients

Machine learning algorithms have been deployed to create predictive models in various medical fields, with some demonstrating improved outcomes compared to their standard-of-care counterparts.... Read more

Point of Care

view channel
Image: The new eye-safe laser technology can diagnose traumatic brain injury (Photo courtesy of 123RF)

Novel Diagnostic Hand-Held Device Detects Known Biomarkers for Traumatic Brain Injury

The growing need for prompt and efficient diagnosis of traumatic brain injury (TBI), a major cause of mortality globally, has spurred the development of innovative diagnostic technologies.... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.