W.L. Gore & Associates announced that it enrolled the first U.S. patient in a clinical trial for its Viafort vascular stent. Gore aims to evaluate Viafort for the treatment of symptomatic inferior vena cava (IVC) obstruction with or without iliofemoral obstruction. The prospective, non-randomized, multi-center, single-arm study … [Read more...] about Gore enrolls first U.S. patient in vascular stent trial
Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Surmodics (Nasdaq:SRDX) announced today that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodics gave the FDA a proposed approach to submit an amended premarket approval application for SurVeil. In January, the FDA indicated that Surmodics’ SurVeil PMA application is … [Read more...] about Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Some hospitalized patients’ infections may develop from their own bacteria in catheters
Researchers in Missouri discovered evidence of infections forming from hospitalized patients' own bacteria in catheters. Studying mice, researchers at Washington University School of Medicine in St. Louis discovered that urinary tract infections (UTIs) can arise after sterile catheter tube insertion into the urinary tract. This can occur even … [Read more...] about Some hospitalized patients’ infections may develop from their own bacteria in catheters
Getinge’s Datascope has another serious intra-aortic balloon pump recall
The FDA issued a notice determining a recall of Getinge subsidiary Datascope's Cardiosave intra-aortic balloon pumps (IABPs) as Class I, the most serious kind. This recall relates to the Swedish medtech company's Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate recall that the FDA determined was Class I in … [Read more...] about Getinge’s Datascope has another serious intra-aortic balloon pump recall
Data backs splanchnic ablation procedure from Axon Therapies
Axon Therapies today announced positive six-month results from a trial for its proprietary splanchnic ablation for volume management (SAVM) therapy. Dr. Marat Fudim, advanced heart failure specialist at Duke University Medical Center, presented results at the Technology and Heart Failure Therapeutics (THT) Conference in Boston. The data came … [Read more...] about Data backs splanchnic ablation procedure from Axon Therapies
FDA sends warning letter to Olympus over endoscope manufacturing
The FDA issued Olympus a warning letter regarding adultered devices following an inspection of the company’s Tokyo facility. This marks the latest warning letter sent by the FDA to Olympus. The company received two separate letters at the end of last year. According to the letter, the agency conducted an inspection of the Tokyo facility … [Read more...] about FDA sends warning letter to Olympus over endoscope manufacturing
Kardium treats first patient in pulsed-field ablation study
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
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
