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 […]
Drug-Eluting Stents
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 […]
Stent makers point to quality-of-life findings by massive federal study
The giant federal study that found the use of stents in stable heart-disease patients is no better than drugs to treat clogged arteries reached another, less-hyped conclusion. Manufacturers of stents for percutaneous coronary intervention (PCI) note that the Ischemia study also concluded that patients who undergo a stenting procedure have a better quality of life. They suffer […]
Study: Stents no better than drugs for stable heart disease
This article has been updated with stock market results and comments from Medtronic. A major new study has concluded that the use of stents in stable heart disease patients is no better than drugs to treat clogged arteries. Results of the Ischemia study were released at the American Heart Association annual meeting in Philadelphia on Saturday. The […]
China approves Biotronik’s Orsiro drug-eluting stent
Biotronik said today that China’s National Medical Products Administration approved its Orsiro drug-eluting stent. Orsiro is a cobalt-chromium stent that elutes the drug sirolimus via the Berlin-based company’s Biolute bioabsorbable polymer coating. Biotronik said it plans to have Orsiro on the Chinese market “in the coming months.” Get the full story at our sister site, […]
BD warns of international device shortages in EO plant legal filing
The Georgia environmental chief’s effort to shut down a Becton Dickinson (NYSE:BDX) medtech sterilization plant could cause widespread shortages of commonly used devices for which BD has a large market share, the company said today in a court filing. On Tuesday, Georgia state Environmental Protection Division director Richard Dunn filed a motion with Newton County Superior Court […]
TCT 2019: Medtronic’s Resolute Onyx non-inferior to Biosensors Biofreedom stent
A study comparing the Resolute Onyx drug-eluting stent from Medtronic (NYSE:MDT) and the BioFreedom stent made by Biosensors International (PINK:BSNRY) showed the Medtronic device to be non-inferior in patients on a one-month dual anti-platelet therapy regimen, according to results presented yesterday at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. Medtronic launched the 2,000-patient study […]
Japan OKs OrbusNeich’s Combo Plus stent
OrbusNeich Medical today said it won market approval in Japan for its Combo Plus coronary stent. The Combo Plus stent is designed to address the risk of stent thrombosis associated with delayed healing in conventional drug-eluting stents. The Combo Plus DES uses endothelial progenitor cell capture technology and abluminal sirolimus drug elution delivered from a biodegradable […]
Cook Medical touts paclitaxel-coated stent PAD study results
Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to […]
ESC Congress 2019: Biotronik beats Abbott at target lesion failure
Biotronik said yesterday that its Orsiro stent tops the Xience stents made by Abbott (NYSE:ABT) when it comes to target lesion failure, according to data from a clinical trial. The randomized, controlled BioSTEMI trial was the first direct comparison between the two drug-eluting stents in patients with acute ST-segment elevation myocardial infarction (STEMI). Biotronik announced […]
FDA wants more study of paclitaxel-eluting devices’ long-term safety
The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who […]