Devices

Biotronik Device for Coronary Artery Perforations OK’d

FDA has approved a Biotronik humanitarian device exemption for its PK Papyrus Covered Coronary Stent System which is intended to treat acute coronary artery perforations, or tears in the blood vessels of the heart. This is the first device approved by the agency for this indication in 17 years, a news release says. It provides 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,” it says.

The balloon-expandable covered coronary stent and delivery system is deployed into the perforated coronary artery vessel, FDA says. Once 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 Covered Coronary Stent System can be a life-saving procedure without the need for open-heart surgery,” it says.

The device was approved based on a review of real-world survey data from 80 patients who received it to treat coronary artery perforations. The stents were successfully delivered to the perforation site in 76 of the 80 patients (95%), and the device successfully sealed the perforation in 73 patients (91%). “There were two deaths that occurred during the PCI procedure, and seven patients underwent treatment to drain a fluid collection around the heart,” FDA says. “Post-procedure, in-hospital death occurred in five patients with perforations successfully sealed by PK Papyrus Stents and one patient in which the PK Papyrus Stent did not successfully seal the perforation.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome