The FDA issued a notice instructing healthcare providers to stop using certain reinforced endotracheal tubes made by Medtronic (NYSE:MDT). This warning extends to NIM Contact EMG reinforced endotracheal tubes and NIM (Standard) EMG reinforced endotracheal tubes. Medtronic offers the neural integrity monitor (NIM) electromyogram (EMG) tubes for … [Read more...] about Medtronic endotracheal tubes recall sparks an FDA warning
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Teleflex has a serious balloon catheter recall, 3 deaths linked to issue
The FDA says a recall of Teleflex (NYSE:TFX) intra-aortic balloon (IAB) catheter kits is Class I, the most serious kind of recall. Teleflex recalled its Arrow FiberOptix IAB catheter kit and Arrow UltraFlex IAB catheter kit. This recall is a correction, not a product removal. However, the issues related to the kits resulted in reports of 31 … [Read more...] about Teleflex has a serious balloon catheter recall, 3 deaths linked to issue
Xeltis wins FDA IDE approval for restorative vascular access conduit pivotal trial
Xeltis announced today that it received FDA investigational device exemption (IDE) to begin a pivotal study of its restorative vascular access conduit. aXess enables the creation of a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and patency of arteriovenous fistula (AVF) with the speed to treatment of … [Read more...] about Xeltis wins FDA IDE approval for restorative vascular access conduit pivotal trial
Atraverse wins FDA nod for left-heart access device, raises $12.5M
Atraverse Medical announced today that the FDA cleared its Hotwire radiofrequency guidewire left-heart access device. The novel device enables zero exchange left-heart access while acting as a rail for catheter-based therapy systems. Steven Mickelsen, the founder of Farapulse, invented the Hotwire system with co-founder Eric Sauter. It's the … [Read more...] about Atraverse wins FDA nod for left-heart access device, raises $12.5M
CereVasc can begin new IDE study of eShunt
CereVasc announced today that it received FDA investigational device exemption (IDE) approval to begin a pivotal study of its eShunt. The FDA said the Boston-based company can initiate the STRIDE pivotal study looking at eShunt in treating normal pressure hydrocephalus. IDE approval allows the company look at the novel system's safety and … [Read more...] about CereVasc can begin new IDE study of eShunt
Abbott wins FDA approval for dissolving drug-eluting scaffold
Abbott announced today that the FDA approved its Espirit everolimus-eluting resorbable scaffold system. The Espirit scaffold treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving. Abbott says that before … [Read more...] about Abbott wins FDA approval for dissolving drug-eluting scaffold
Fresenius Medical Care recalls more than 2 million catheter components
The FDA says a recall of Fresenius Medical Care catheter extension sets and luer lock adapters is Class I, the most serious kind. Fresenius Medical Care initiated the recall of a number of its Stay-Safe luer lock adapters and catheter extensions on Jan. 23, 2024. It extends to nearly 2.2 million devices distributed between March 5, 2003, and … [Read more...] about Fresenius Medical Care recalls more than 2 million catheter components
FDA approves Boston Scientific’s Agent drug coated balloon
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented … [Read more...] about FDA approves Boston Scientific’s Agent drug coated balloon
FDA panel votes in favor of Abbott TriClip TEER system for treating tricuspid regurgitation
Abbott (NYSE:ABT) announced today that an FDA advisory committee ruled that the benefits of its TriClip outweigh the risks in treating tricuspid regurgitation (TR). The Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA confirmed this with votes registering 13 to 1 in favor of TriClip’s benefits. Abbott … [Read more...] about FDA panel votes in favor of Abbott TriClip TEER system for treating tricuspid regurgitation
Medtronic PulseSelect pulsed field ablation wins FDA approval
The FDA has approved the Medtronic PulseSelect pulsed field ablation (PFA) system, the device developer said today. PulseSelect is the first PFA technology approved for use in the U.S., as well as the first PFA technology with FDA breakthrough designation to win approval. The minimally invasive, cardiac ablation system is indicated for the … [Read more...] about Medtronic PulseSelect pulsed field ablation wins FDA approval
