BD has issued an urgent field safety notice for its Venovo venous stent system. The notice out of Germany warns of potential delayed deployment and silicone embolization if the proximal end of the Venovo venous stent system does not immediately expand upon deployment and remains connected to the stent cushion on the delivery system. According … [Read more...] about BD issues urgent field safety notice for Venovo venous stent system
Stents
Medtronic enrolls first patient in head-to-head aortic stent graft trial with Gore Medical
Medtronic (NYSE:MDT) today announced that it enrolled the first patient in a head-to-head trial of aortic stent graft systems. The Advance trial evaluates the Medtronic Endurant II/IIs and the Gore Excluder AAA device family. Medtronic said in a news release that it expects to enroll 550 patients at up to 50 global centers in the trial. After … [Read more...] about Medtronic enrolls first patient in head-to-head aortic stent graft trial with Gore Medical
The top 10 catheter innovation news stories of 2022
This year was a big one for catheter innovation as medtech companies large and small received regulatory approvals and researchers developed catheters that could soon make navigating the vasculature system easier. The numerous innovations weren't just limited to adults. One company launched a cryoablation catheter for children as young as 2 … [Read more...] about The top 10 catheter innovation news stories of 2022
Endologix AFX2 system wins FDA approval for PMA supplement
Endologix today announced it received FDA approval for a pre-market approval supplement relating to its AFX2 system. The expanded approval includes an updated warning and the most contemporary clinical information in the labeling for the AFX2 system. Clinical data was added to the instructions for use (IFU) to include: - Final results … [Read more...] about Endologix AFX2 system wins FDA approval for PMA supplement
FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions. Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions … [Read more...] about FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
Getinge partners with Medtronic to make Radiant balloon-expandable covered stent
Getinge today announced a partnership with Medtronic (NYSE:MDT) over the Radiant balloon-expandable stent, which received CE mark. Radiant is designed for use in chimney endovascular aneurysm repair (ChEVAR) with the Endurant II/IIs stent graft system. It maintains perfusion to renal arteries when used in combination with the stent graft. The … [Read more...] about Getinge partners with Medtronic to make Radiant balloon-expandable covered stent
Medtronic launches Onyx Frontier drug-eluting stent
Medtronic (NYSE:MDT) today launched its newest drug-eluting coronary stent, Onyx Frontier. The Fridley, Minnesota-based company designed the Onyx Frontier drug-eluting stent (DES) to build upon its Resolute Onyx DES. It uses the same stent platform as the Resolute Onyx and has an enhanced delivery system to increase acute performance in … [Read more...] about Medtronic launches Onyx Frontier drug-eluting stent
The 24 best medical device innovations of 2022
The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products … [Read more...] about The 24 best medical device innovations of 2022
FDA clears Glaukos’ iStent Infinite
Glaukos this week announced it received FDA 510(k) clearance for its iStent Infinite trabecular micro-bypass system. The FDA clearance indication is for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients who have primary open-angle glaucoma. San Clemente, California-based Glaukos designed iStent Infinite … [Read more...] about FDA clears Glaukos’ iStent Infinite
FDA approves Biotronik’s self-expanding stent system
Biotronik announced today that it received FDA approval for its Pulsar-18 T3 peripheral self-expanding stent system. Pulsar-18 T3 combines a 4-French low-profile delivery system with a tri-axial system with a braided shaft design and thin struts with low chronic outward force (COF), creating an improved implantation procedure for endovascular … [Read more...] about FDA approves Biotronik’s self-expanding stent system
