LAKE OSWEGO, Ore., Sept. 14, 2018 /PRNewswire/ -- BIOTRONIK today announced the FDA approval of the PK Papyrus covered coronary stent system under Humanitarian Device Exemption for use in the emergency treatment of acute coronary perforations.1,2 PK Papyrus received CE marking in 2013.
Built on BIOTRONIK's ultrathin stent platform, PK Papyrus is the first FDA approved device for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter. The covered stent is available in 17 sizes, expanding treatment options and helping avoid the need for emergency coronary artery bypass grafting. PK Papyrus is the only 5 French compatible covered coronary stent available in the United States.
"In rare cases of a coronary perforation, time is the enemy," said Dr. Dean Kereiakes, Interventional Cardiologist and Medical Director of The Christ Hospital and Vascular Center, Cincinnati, Ohio. "The device's superior flexibility and tracking means that PK Papyrus delivers more like a conventional stent and can treat a perforation more quickly, avoiding further complications. Hospitals need to have this potentially lifesaving device ready for physicians to use."
The ultrathin, single-stent design and unique electrospun polyurethane membrane contribute to PK Papyrus' superior performance. BIOTRONIK's covered stent is 58 percent more flexible3 and has a 23 percent smaller crossing profile compared to Graftmaster.4 The latter has a layered dual-stent design and is the only other covered coronary stent available in the United States.
"Perforation is very uncommon, but physicians need to be fully prepared for this emergency event," said Marlou Janssen, President of BIOTRONIK, Inc. "It's unacceptable that this critical care area has seen no innovation in nearly two decades. PK Papyrus has been trusted in various international markets since 2013. 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."
Fewer than 4,000 percutaneous coronary interventions per year in the United States require a covered stent, classifying PK Papyrus as a Humanitarian Use Device. BIOTRONIK will make the lifesaving product PK Papyrus available to US physicians in 2019 in alignment with BIOTRONIK's goal to receive FDA approval for the full range of a highly innovative Vascular Intervention portfolio.
1 Humanitarian Device. Authorized by Federal law for use in the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter. The effectiveness of this device for this use has not been demonstrated.
2 Institutional Review Board approval is required for use.
3 Compared to Jostent Graftmaster 3.0/16 (BIOTRONIK data on file).
4 Compared to Graftmaster 2.8/16 (BIOTRONIK data on file).
Jostent and Graftmaster are registered trademarks of the Abbott Group of Companies.
BIOTRONIK is a medical technology company that develops trusted and innovative cardiovascular and endovascular solutions. Driven by purpose and integrity, BIOTRONIK has partnered with hospitals and health systems for more than 50 years, helping to deliver care that saves and improves the lives of millions of patients with heart and blood vessel diseases. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. BIOTRONIK has US offices in New York City and Lake Oswego, Oregon.