Medtronic has issued a warning letter regarding some of its Perfusion Tubing Packs. Friedly, Minnesota-based Medtronic's urgent field safety notice informs users that some of its Perfusion Tubing Packs were manufactured without device-level testing for bacterial endotoxin, which is a necessary step to support non-pyrogenic label claim. The … [Read more...] about Medtronic issues warning for some perfusion tubing packs
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Medtronic faces longer road to renal denervation
Medtronic (NYSE:MDT) will continue the clinical study of its Symplicity Spyral renal denervation (RDN) system for hypertension into next year after lacking the positive results needed to end enrollment early. Fridley, Minnesota-based Medtronic said last month that it hoped to present results of the Spyral HTN-ON MED trial at the Cardiovascular … [Read more...] about Medtronic faces longer road to renal denervation
Medtronic wins CE mark approval for radial artery access portfolio
Medtronic today said it has received CE mark approval for its radial artery access portfolio. The radial artery access devices include the Rist 079 radial access guide catheter and the Rist radial access selective catheter. Medtronic designed the Rist 079 guide catheter to access the neuro vasculature through the radial artery instead of … [Read more...] about Medtronic wins CE mark approval for radial artery access portfolio
Medtronic’s Pipeline Flex problems expand
The FDA today issued a notice confirming a Class I recall of the Pipeline Flex embolization device from Medtronic (NYSE:MDT). Several models of the Pipeline Flex embolization device and Pipeline Flex embolization device with Shield Technology were affected, with 8,825 devices recalled in the U.S., having been distributed between April 18, 2019, … [Read more...] about Medtronic’s Pipeline Flex problems expand
Medtronic releases Navablate study results for bronchoscopic microwave ablation
Medtronic (NYSE:MDT) reported new clinical data from its Navablate study of bronchoscopic microwave ablation with its Emprint ablation catheter kit to treat malignant lung nodules. “Patients with malignant lesions in the lung often have limited therapy options due to lesion locations, comorbidities and treatment side effects,” said one of the … [Read more...] about Medtronic releases Navablate study results for bronchoscopic microwave ablation
FDA approves Medtronic next-gen Evolut FX TAVR system
Medtronic today announced that its Evolut FX TAVR system has won FDA approval. Fridley, Minn.–based Medtronic designed the self-expanding transcatheter aortic valve replacement system to treat symptomatic severe aortic stenosis. The TAVR system uses a supra-annular valve design that has demonstrated hemodynamic performance that is superior to … [Read more...] about FDA approves Medtronic next-gen Evolut FX TAVR system
Medtronic launches Prevail drug-coated balloon catheter in Europe
Medtronic today announced that it has launched its Prevail drug-coated balloon catheter in Europe. Dublin-based Medtronic designed the Prevail catheter for percutaneous coronary intervention procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease. During the procedure, the balloon inflates within the … [Read more...] about Medtronic launches Prevail drug-coated balloon catheter in Europe
Medtronic has a Class I recall of some angiographic guidewires
The FDA has classified the recall of some angiographic guidewires made by Medtronic (NYSE:MDT) as Class I, the most serious kind. Medtronic’s angiographic guidewire component affected by the recall helps place catheters into the vasculature during angiography or other interventional procedures. Get the full story at our sister site, MassDevice. … [Read more...] about Medtronic has a Class I recall of some angiographic guidewires
Medtronic wins expanded FDA approval for cryoablation catheters
Medtronic (NYSE:MDT) announced today that it received FDA expanded approval for its Arctic Front family of cardiac cryoablation catheters. Fridley, Minn.-based Medtronic's Arctic Front family of catheters treat recurrent symptomatic paroxysmal atrial fibrillation (AFib) as an alternative to antiarrhythmic drug (AAD) therapy as an initial rhythm … [Read more...] about Medtronic wins expanded FDA approval for cryoablation catheters
Is renal denervation back as a high blood pressure treatment?
Medtronic (NYSE:MDT) today reported clinically significant and sustained blood pressure reduction among nearly 3,000 people with uncontrolled hypertension treated with the company’s Symplicity renal denervation system. The study results, reported today out of the 2021 EuroPCR Annual Meeting, come the same week as ReCor Medical touted its … [Read more...] about Is renal denervation back as a high blood pressure treatment?