InspireMD today said it received FDA approval to proceed with a pivotal study of its CGuard Carotid Stent System. The investigational device exemption from the FDA will allow the company to study the device for the prevention of stroke in patients in the U.S. Get the full story on our sister site, Medical Tubing + […]
Boston Scientific stent gains added Medicare coverage
Boston Scientific (NYSE:BSX) announced today that CMS granted a new technology add-on payment (NTAP) for its Eluvia system. Marlborough, Mass.-based Boston Scientific’s Eluvia drug-eluting vascular stent system received the NTAP as part of the 2021 inpatient prospective payment system (IPPS). The NTAP will be made effective on Oct. 1, 2020, to provide eligible hospitals with incremental […]
CryoLife buys Ascyrus Medical
CryoLife (NYSE:CRY) announced today that it will acquire Ascyrus Medical and its Ascyrus Medical Dissection Stent. The financial terms of the deal were not disclosed. AMDS is an aortic arch remodeling device used for the treatment of acute type A aortic dissections. The acquisition will strengthen CryoLife’s position in the growing aortic repair market, according to […]
Medtronic touts results of venous self-expanding stent system study
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 […]
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