Tag: Cardiovascular devices

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…

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By: Matt Danford
June 27, 2024
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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…

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By: Matt Danford
June 14, 2024
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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…

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By: Matt Danford
May 24, 2024
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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…

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By: Matt Danford
May 22, 2024
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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…

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By: Matt Danford
May 20, 2024
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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…

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By: Matt Danford
May 17, 2024
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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,…

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By: Matt Danford
May 16, 2024
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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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By: Matt Danford
May 9, 2024
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Gene-edited pig kidney, heart pump combined in transplant surgery milestone

Editor's Note The second-ever living recipient of a gene-edited pig kidney was the first to have the new organ paired with a mechanical heart pump, according to an April 24 CNN report. The subject, 54-year-old Lisa Pisano, underwent the milestone surgery at NYU Langone Health. She had heart failure and…

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By: Matt Danford
April 25, 2024
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FDA Class 1 recall renews concern about historically problematic heart pumps

The US Food & Drug Administration (FDA) announced a Class 1 recall on Monday for Abbott/Thoratec Corp.’s HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due due to biological material buildup obstructing the devices. According to an April 16 CBS News report, surgeons first noticed problems with the…

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By: Matt Danford
April 17, 2024
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