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Stents

Boston Scientific initiates coronary drug-coated balloon study in U.S.

May 12, 2021 By Danielle Kirsh

Boston Scientific AGENT DCB

Boston Scientific (NYSE:BSX) this week launched its Agent IDE trial for its Agent drug-coated balloon. The U.S. prospective, randomized clinical trial will evaluate the safety and effectiveness of a drug-coated balloon (DCB) in patients with coronary in-stent restenosis in lesions up to 26 mm in length in a coronary artery 2.0 mm to 4.0 mm in […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Stents, Vascular Tagged With: Boston Scientific

Boston Scientific to expand its Maple Grove, Minn. campus

March 8, 2021 By Chris Newmarker

Boston Scientific Maple Grove

Boston Scientific (NYSE:BSX) is planning a fourth building at its Maple, Grove, Minn. campus to support expanded nitinol stent manufacturing. The Maple Grove Planning Commission is scheduled to review project plans tonight for the roughly 76,000 ft2 building. “This new building will allow for movement of some production currently taking place in existing buildings on that campus, […]

Filed Under: Business/Financial News, Featured, Stents Tagged With: Boston Scientific, Minnesota

Abbott touts Xience DES study results

October 15, 2020 By Nancy Crotti

A pair of studies of Abbott’s Xience drug-eluting stent showed no difference between shorter courses of treatment with dual antiplatelet therapy (DAPT) compared with 12 months of DAPT following implantation of the XIENCE drug-eluting stent (DES) in patients who are at a high risk of bleeding. Abbott presented the late-breaking data today at TCT Connect, the […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Implants, Stents Tagged With: abbott, TCT 2020

Medinol stent performs just as well as Medtronic Resolute, study says

January 6, 2020 By Chris Newmarker

Medinol EluNIR drug-eluting stent

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Stents Tagged With: Cardinal Health, medinol, Medtronic

China approves Biotronik’s Orsiro drug-eluting stent

October 30, 2019 By Brad Perriello

Biotronik's Orsiro

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.” “Orsiro will be a valuable addition to our […]

Filed Under: Cardiovascular, Featured, Regulatory/Compliance, Stents Tagged With: Biotronik

TCT 2019 Roundup: Medtronic’s Resolute Onyx non-inferior to Biosensors BioFreedom stent

September 27, 2019 By Brad Perriello

TCT 2019

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 […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Stents Tagged With: biosensors, Medtronic, TCT 2019

Japan OKs OrbusNeich’s Combo Plus stent

September 25, 2019 By Danielle Kirsh

orbusneich-logo

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 […]

Filed Under: Drug-Device Combinations, Featured, Regulatory/Compliance, Stents Tagged With: OrbusNeich

Cook Medical touts paclitaxel-coated stent PAD study results

September 10, 2019 By Nancy Crotti

Cook Medical - updated logo

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 a […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Stents, Uncategorized Tagged With: cook medical, FDA

Study: No difference between Biotronik, Medtronic or Boston Scientific stents

August 20, 2019 By Brad Perriello

coronary stent

A study comparing drug-eluting stents made by Biotronik, Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) found no statistically significant difference on target vessel failure or stent thrombosis after three years. The 3,514-patient Bio-Resort trial compared Biotronik’s Orsiro biodegradable sirolimus-eluting stent, Medtronic’s thin-strut zotarolimus-eluting Resolute Integrity stent and the Synergy biodegradable everolimus-eluting stent. Three-year results for some 3,393 […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Stents Tagged With: Biotronik, Boston Scientific, Medtronic

FDA panel wants more, better data on paclitaxel-eluting devices

June 21, 2019 By Brad Perriello

FDA

An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Stents, Vascular Tagged With: Becton Dickinson, Boston Scientific, cook medical, Medtronic, Peripheral Artery Disease, Royal Philips

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