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
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?
Medtronic wins FDA breakthrough nod for Emprint ablation catheter kit
Medtronic (NYSE:MDT) announced today that it received FDA breakthrough device designation for its Emprint ablation catheter kit. Fridley, Minn.-based Medtronic's catheter is designed to be used in conjunction with the Emprint microwave generator and the Medtronic lung navigation platform to offer a minimally invasive, localized treatment of … [Read more...] about Medtronic wins FDA breakthrough nod for Emprint ablation catheter kit
Medtronic stent graft recall is serious
The FDA has deemed the recall of the Medtronic (NYSE:MDT) Valiant Navion thoracic stent-graft system as Class I, the most serious kind. Medtronic's Valiant Navion is designed to repair lesions of the descending thoracic aorta. It uses a long catheter to place the stent graft inside the aorta. The stent graft expands to fit within the aorta to … [Read more...] about Medtronic stent graft recall is serious
FDA committee to examine safety of endovascular stent grafts
FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies. Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially … [Read more...] about FDA committee to examine safety of endovascular stent grafts
FDA approves Medtronic’s Harmony transcatheter pulmonary valve system
FDA has approved a Medtronic device described as a first-in-the-world, non-surgical heart valve to treat severe pulmonary valve regurgitation — a condition often arising from congenital heart disease. The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease might need additional … [Read more...] about FDA approves Medtronic’s Harmony transcatheter pulmonary valve system
Medtronic launches DCB for dialysis patients in Japan
Medtronic (NYSE:MDT) this week said it launched its first drug-coated balloon in Japan for patients undergoing hemodialysis. The company launched its In.Pact AV drug-coated balloon, which is indicated for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae in patients with end-stage renal … [Read more...] about Medtronic launches DCB for dialysis patients in Japan