Greg Piefer, PhD, chief executive and founder of Shine, a Wisconsin-based radiopharmaceutical company that is building the world’s largest medical isotope production facility in Janesville, Wisconsin, explains progress on the company's fusion reactor that will become the first sustained U.S. commercial supplier of molybdenum-99 in decades.
Cardiology is number one in FDA Breakthrough Device designations at 218, the highest number out of all other clinical categories. This includes 16 new devices cleared in the past year.
The JenaValve Transcatheter Heart System on display at TCT 2023. Photo by Dave Fornell.
Edwards Lifesciences asked the U.S. Federal Trade Commission (FTC) this week to dismiss the complaint against the company's acquisition of JenaValve this week. A healthcare market analysis firm also said the FTC actions will likely impact the timing of an FDA clearance of the Trilogy heart valve.
“It is your responsibility to be the patient’s advocate,” one expert explained. “We, as the nurses and technologists, have to speak up when we see something that isn’t right.”
The Amplatzer Piccolo Occluder was FDA cleared in 2019 for transcatheter patent ductus arteriosus (PDA) closure in premature infants. Photo courtesy of Abbott.
Transcatheter patent ductus arteriosus (PDA) closure has been a mainstay in congenital interventional cardiology for decades, but changes in the standard of care have resulted in catheter-based treatments overtaking surgical procedures.
More and more care teams are treating BAV stenosis with TAVR instead of surgical aortic valve replacement. Self-expanding and balloon-expandable valves appear to have their own benefits—as well as their own risks.
Speaker issues are causing the devices to stop communicating with the user's CGM. Dozens of patient injuries have been reported, and the company is prepping a software update.
Hemodynamic valve deterioration after one year was more common in patients with a small aortic annulus. In fact, receiving a larger valve was linked to a “protective” quality that appeared to help keep the risk of such complications to a minimum.
New ACC/AHA recommendations encourage clinicians to take a proactive approach when managing patients with elevated or high blood pressure. The inclusion of renal denervation in this document represents clear progress for a relatively new technology.
