Kardium announced today that it successfully treated the first patients in the PULSAR clinical study for its Globe PF pulsed-field ablation (PFA) system. Vancouver, British Columbia-based Kardium recently received FDA investigational device exemption (IDE) to conduct the study. The international, multicenter PULSAR study evaluates the safety and … [Read more...] about Kardium treats first patient in pulsed-field ablation study
Catheters
Medtronic wins CE mark for Affera ablation system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Affera mapping and ablation system. The Affera system includes the Sphere-9 catheter and Affera Prism-1 mapping software. Together, the system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping. It maps and ablates … [Read more...] about Medtronic wins CE mark for Affera ablation system
FDA clears first device authorized under Safer Technologies Program
The FDA last week cleared a new gastric calibration tube, marking the first authorization of a device under the agency's Safer Technologies Program. FDA launched its Safer Technologies Program in 2021. It modeled the program on its breakthrough devices program. The Safer Technologies Program (STeP) covers devices that could improve the safety of … [Read more...] about FDA clears first device authorized under Safer Technologies Program
The biggest cardiology tech stories from ACC.23
Major medtech players presented a range of intriguing studies at a gathering of some of the biggest names in the cardiology tech space. Some of the hottest topics were covered this past week at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC) in New Orleans. Ablation, … [Read more...] about The biggest cardiology tech stories from ACC.23
Biosense Webster marks first cases with dual energy ablation tech
Biosense Webster today announced the first cases with its investigational Thermocool SmartTouch SF dual energy catheter for treating AFib. The system enables doctors performing an ablation to toggle between two types of energy: pulsed-field and radiofrequency. It appears to be the Johnson & Johnson MedTech subsidiary's answer to the dual … [Read more...] about Biosense Webster marks first cases with dual energy ablation tech
Medtronic pulsed-field ablation system exceeds safety goal in study
Medtronic (NYSE:MDT) announced today that its PulseSelect pulsed-field ablation (PFA) system exceeded its safety performance goal in a clinical trial. PulseSelect registered an adverse event rate of 0.7%. Medtronic said that marks one of the lowest adverse event rates of any previous FDA investigational device exemption (IDE) trial for AFib … [Read more...] about Medtronic pulsed-field ablation system exceeds safety goal in study
Junkosha names new US leadership
Japanese fluoropolymer supplier Junkosha today announced new leadership for its U.S. subsidiary. Joe Rowan has retired as CEO and president of Junkosha USA but will remain as an advisor as Mike Winterling takes over as chief operating officer. “Our aim is to be acknowledged as the most responsive partner for specialized high-performance … [Read more...] about Junkosha names new US leadership
FDA clears Perfuze’s Millipede access catheter
Perfuze recently announced that it received FDA 510(k) clearance for its Millipede 088 access catheter. The Galway, Ireland-based company designed Millipede 088 to facilitate the safe insertion and guidance of microcatheters for neurointerventional or diagnostic procedures. The company hopes the device will advance all aspects of stroke … [Read more...] about FDA clears Perfuze’s Millipede access catheter
How Penumbra’s smart-sucking algorithms and catheters speed up clot removal
Blood loss is a big problem when using aspiration catheters to remove blood clots from patients' veins and arteries. "You suck out the clot, you also suck out the blood," said Sandra Lesenfants, president of the interventional business at Penumbra (NYSE:PEN). Algorithms developed by Penumbra's software team for the company's continuous … [Read more...] about How Penumbra’s smart-sucking algorithms and catheters speed up clot removal
Alleviant Medical raises $75M for no-implant heart failure treatment
Alleviant Medical has raised $75 million to support a global pivotal trial of its catheter-delivered interatrial shunt to treat heart failure. The FDA provided the Austin, Texas–based company with an Investigational Device Exemption for the clinical trial in November 2022. Researchers have designed the ALLAY-HF study to demonstrate the safety … [Read more...] about Alleviant Medical raises $75M for no-implant heart failure treatment
