Surgeons implant first medically suspended heart pump in US
Editor's Note Cardiothoracic surgeons at Emory University Hospital have conducted the first US implantation of the BrioVAD System, a new ventricular assist device (VAD) from BrioHealth Solutions, Cardiovascular Business News reported November 25. According to the article, the BrioVAD System features a magnetically suspended, hemocompatible pump designed to minimize adverse…
Study: Early detection of atherosclerosis linked to lower mortality risk
Editor's Note A September 2024 study, published in the Journal of the American College of Cardiology, found that subclinical atherosclerosis progression in asymptomatic individuals is strongly linked to increased risk of death from any cause, CathLab Digest September 30 reports. The study, led by Mount Sinai Fuster Heart Hospital researchers,…
Post-CABG cardiac shockwave therapy shows promise in early study
Editor's Note Using a device they call a “space hairdryer,” researchers in Austria applied gentle shockwaves to regenerate heart tissue after coronary artery bypass graft surgery (CABG) in a study with potential implications for millions of patients, BBC News reported June 20. Researchers are now seeking larger trials, European regulatory…
FDA announces Class 1 recalls for patient return electrodes, intra-aortic balloon catheters, anesthesia systems
Editor's Note The US Food & Drug Administration (FDA) has announced Class 1 recalls—the most severe category, indicating risk of serious injury or death—for three products: MEGA SOFT Pediatric Patient Return Electrodes from Megadyne, Vaporizer Sevoflurane Maquet Filling from Getinge; and Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex…
FDA announces Class 1 recall for Vyaire Medical’s Twin Tube CPX sample lines
Editor's Note A choking hazard prompted the US Food and Drug Administration (FDA) to designate Vyaire Medical’s recall of Twin Tube sample lines—critical components of the Vyntus CPX system—as Class 1, the most serious category of recall indicating a risk of serious injury or death. According to the agency’s May…
Study: Transcatheter aortic valve replacement offers similar outcomes to surgical aortic valve replacement
Editor's Note The largest scale analysis so far available comparing surgical aortic valve replacement (SAVR) to longer-term percutaneous devices for transcatheter aortic valve replacement (TAVR) supports the comparable long-term safety and efficacy of the latter procedure. According to a May 15 report in Medical Xpress, the findings raise important considerations for valve…
Heart pump recall, lack of donor organs create concern for heart failure patients
Editor's Note The lack of available hearts for transplantation combined with the recent recall of Abbott’s HeartMate 3 left ventricular assist device (LVAD) “makes the current therapy landscape for heart failure much more dire,” according to a May 20 report in Medical Device Network. The recall of the device, which…
Long-lasting heart valves poised to set world record
Editor's Note More than 45 years after surgery, Mary Ann Kozlowski’s mechanical heart valves are still pumping—and Guinness is reviewing an application to list her as the new world record-holder for longevity of a double-valve replacement. That’s according to a May 15 report in the Erie-Times News, which detailed how…
FDA announces class 1 recalls for heart devices, ventilators
Editor's Note The US Food and Drug Administration (FDA) has classified recalls of Abbot’s HeartMate 3 Left Ventricular Assist System (LVAS) implant kits and Phillips Respironics' Trilogy Evo ventilators as class 1, the most serious category indicating risk of serious injury or death. Used while waiting for recovery, a transplant,…
FDA warns of continued cardiac pump safety concerns after series of recalls
Editor's Note The US Food and Drug Administration (FDA) is urging healthcare providers to avoid using Getinge heart devices due to continued safety concerns that remain unaddressed despite previous recalls. Issued to healthcare providers May 8, the warning letter applies to Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices…
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