Medtronic (NYSE:MDT) announced that the clinical trial for its Abre venous self-expanding stent system met its primary safety and effectiveness endpoints. The Abre stent system is designed for treating patients with iliofemoral venous outflow obstruction. The prospective, interventional, single-arm, multi-center, global trial with 200 subjects across 24 sites evaluated primary patency at 12 months for effectiveness […]
Endologix recall of abdominal stent graft system is Class I
Endologix (NSDQ:ELGX) is warning customers that material weakness during the manufacturing process is causing polymer leaks during implantation of its Ovation iX abdominal stent graft system. The FDA today gave the recall a Class I designation — its most serious level. Out of 12,763 Ovation iX systems sold between August 2015 and May 2020, there were […]
Medtech manufacturers must add warning label to drug-eluting PAD devices
UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]
Medtronic lands CE Mark for shorter therapy for high bleeding risk heart patients
Medtronic (NYSE:MDT) announced today that it received CE Mark approval for a one-month indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx. The medtech giant’s indication is for one-month dual antiplatelet therapy (DAPT) in HBR patients implanted with the Resolute Onyx drug-eluting stent (DES). In a news release, the company touted the indication […]
Survey: Half of heart attack patients avoid the hospital during pandemic
The number of heart attack patients seeking urgent hospital care has dropped by more than 50% worldwide during the COVID-19 outbreak, according to a survey by the European Society of Cardiology (ESC). The survey of 3,101 healthcare professionals in 141 countries was conducted in mid-April.The findings are published in European Heart Journal — Quality of Care and […]
15 heart devices that could boost their manufacturers’ sales
Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals […]
Endologix wins FDA approval for abdominal stent graft system
Endologix today said it received FDA approval for its Alto abdominal stent graft system. The company said it received approval based on its regulatory submission that included results from its Elevate Investigational Device Exemption clinical study. Under the terms of the FDA approval, the first 100 patients after commercial launch will be included in a […]
Supira Medical closes $35m Series B for its pVAD tech
Supira Medical announced that it closed a $35 million Series B financing round and appointed Nitin Salunke as its new president & CEO. Cormorant Asset Management led the financing, which officially closed on Feb. 25. The Capital Partnership, 415 Capital, AMED Ventures and Shifamed Angels all participated as well. Campbell, Calif.-based Supira Medical said in […]
FDA clears Cleveland Clinic 3D-printed airway stents
The FDA recently cleared 3D-printed, patient-specific stents developed by a doctor at the Cleveland Clinic. Cleveland Clinic physician Tom Gildea developed the stents to keep open the airways of patients with serious breathing disorders caused by inflammation, trauma, tumors and other masses. Airway stents come in a limited number of sizes and shapes and are […]
Reflow Medical wins FDA breakthrough nod for Temporary Spur Stent System
Reflow Medical announced yesterday that its Temporary Spur Stent system for treating below-the-knee peripheral artery disease (PAD) won FDA breakthrough device designation. The Temporary Spur Stent system includes radially expandable spikes designed to create multiple pathways for delivering antiproliferative drugs for increased uptake into the vessel wall for facilitating acute luminal gain without leaving anything […]
Medinol stent performs just as well as Medtronic Resolute, study says
The EluNIR drug-eluting stent made by Medinol performed just as well as the Resolute Integrity or Resolute Onyx stents from Medtronic (NYSE:MDT), according to new clinical study results from an international team of researchers. The randomized clinical trial — conducted by researchers from the U.S., Israel, Canada and the Netherlands — involved 2,221 people and compared […]
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