German biomedical technology firm Biotronik has secured approval from the US Food and Drug Administration (FDA) for the PK Papyrus covered coronary stent system.
The FDA has approved the new PK Papyrus device for the treatment of acute coronary artery perforations or tears in the blood vessels of the heart.
A coronary artery perforation will take place during percutaneous coronary intervention (PCI) procedures.
The new device is a balloon-expandable covered coronary stent and delivery system, which can be advanced into the perforated coronary artery vessel with the support of a balloon catheter.
Once the device is implanted, it serves as a physical barrier to seal the tear in the artery wall, while enabling blood to flow through the device to the heart muscle.
According to the FDA, successful sealing of a coronary perforation with the new device will be a life-saving procedure without open-heart surgery.
The FDA assessed data of the PK Papyrus system under the humanitarian device exemption process.
The regulator also assessed real-world survey data from 80 patients who secured PK Papyrus stents to treat coronary artery perforations.
Biotronik delivered PK Papyrus stents to the perforation site in 76 of the 80 patients (95%), while the device successfully sealed the perforation in 73 patients (91.3%).
The FDA’s Center for Devices and Radiological Health cardiovascular devices division director Dr Bram Zuckerman said: “An acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel procedures.
“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.”
In August 2017, Biotronik secured FDA approval for its Edora HF-T QP, a MR conditional quadripolar (QP) cardiac resynchronization therapy pacemaker (CRT-P).
Claimed to be the smallest MR conditional CRT-P in the US, Edora HF-T QP features MRI AutoDetect technology, as well as closed loop stimulation (CLS) and the firm’s home monitoring capabilities.