Surgery-preventing spinal stimulation poised for FDA approval
Editor's Note A recent trial marks the last hurdle for researchers to request regulatory approval for a noninvasive alternative to spinal surgery, according to a May 20 report in MIT Technology Review. Onward Medical’s ACRex device delivers electrical stimulation to the spinal cord via two wired electrodes placed just below…
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…
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 issues class 1 recall for medical catheters
Editor's Note The US Food and Drug Administration (FDA) has designated Route 92 Medical’s recall of products containing the Tenzing 7 delivery catheters as class 1, the most serious classification indicating risk of serious injury or death. The devices are used to deliver microcatheters to the blood vessels in the…
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…
FDA medical device Class 1 recalls trend upward
Editor's Note The number of US Food and Drug Administration (FDA) Class 1 recalls—the most serious classification—for medical devices has been trending upwards. Regulatory News, a publication of the Regulatory Affairs Professional Society (RAPS), reported the news April 25. According to the report, Anne Reid, program director of the Office…
FDA announces class 1 recall for disposable biopsy needle kit
Editor's Note Microscopic stainless steel debris on the insides of biopsy needles prompted the FDA to issue a class 1 recall—indicating risk of death or serious injury—for Elekta Instrument’s Disposable Biopsy Needle Kit, which is used with the Leksell Stereotactic System for brain tissue sampling during neurosurgery, the disposable biopsy…
FDA announces class 1 recalls for infusion pumps, anesthesia workstation
Editor's Note Reports of spontaneous backup battery failure in Dreager Inc.’s Perseus A500 anesthesia workstation and multiple failures in InfuTronix, LLC’s Nimbus infusion pump systems prompted the FDA to classify manufacturer recalls as class 1, the most serious categorization indicating risk of serious harm or death. According to an April…
Joint replacement manufacturer recalls products after FDA packaging warning
Editor's Note A January complaint about inefficient packaging for joint replacement products has prompted the manufacturer to recall certain knee and shoulder system devices after initially declining to take the products off the market, according to an April 23 report in Health Exec. The manufacturer, Exactech, is now recalling a…
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