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
Stents
Getinge partners with Medtronic to make Radiant balloon-expandable covered stent
Getinge announced 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 … [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
Advanced NanoTherapies closes $7.2M Series A for drug-coated balloon
Advanced NanoTherapies announced today that it closed an oversubscribed Series A equity financing round. Los Gatos, California-based Advanced NanoTherapies, which develops the SirPlux Duo drug-coated balloon (DCB) for treating de novo coronary artery disease (CAD) lesions, has now raised $12.5 million in total since September 2020. Get the full … [Read more...] about Advanced NanoTherapies closes $7.2M Series A for drug-coated balloon
Endologix reports positive results from percutaneous bypass trial
Endologix announced today that 12-month results from a trial of its Detour system demonstrated a low rate of complications. Irvine, California-based Endologix's Detour 2 FDA investigational device exemption (IDE) study was designed to evaluate the safety and effectiveness of the Detour system for percutaneous bypass in the treatment of … [Read more...] about Endologix reports positive results from percutaneous bypass trial
Getinge’s Atrium Medical has a Class I recall over covered stents
The FDA today determined that Atrium Medical's recall of some of its iCast covered stents is Class I, the most serious kind. Hudson, N.H.–based Atrium Medical — a subsidiary of Swedish medtech giant Getinge — is recalling certain iCast covered stent systems due to complaints of separation of the balloon or catheter hub from the delivery system … [Read more...] about Getinge’s Atrium Medical has a Class I recall over covered stents
Medtronic’s Resolute Onyx drug-eluting stent demonstrates strong safety, efficacy
Data presented today at the EuroPCR 2022 event supported the use of the Medtronic (NYSE:MDT) Resolute Onyx drug-eluting stent. University of Padua Medical School Head of Interventional Cardiology Dr. Giuseppe Tarantini presented late-breaking clinical trial results from the investigator-initiated, Medtronic-funded ROLEX (Revascularization Of … [Read more...] about Medtronic’s Resolute Onyx drug-eluting stent demonstrates strong safety, efficacy
