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Stents

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

EuroPCR 2019: Elixir Medical touts DynamX

May 23, 2019 By Brad Perriello

Elixir Medical's DynamX stent

Elixir Medical touted clinical and imaging results from a study of its DynamX drug-eluting stent, which is designed to restore normal pulsatility and adaptive remodeling in blood vessels after treating a coronary lesion. DynamX, introduced in 2017 at the annual Transcatheter Cardiovascular Therapeutics meeting, is a cobalt-chromium stent with a biodegradable polymer coating that releases […]

Filed Under: Cardiovascular, Clinical Trials, Featured, Stents Tagged With: Biotronik, corindus, Elixir Medical Corporation, EuroPCR 2019

Medtronic wins expanded FDA indication for Resolute DES

February 26, 2019 By Fink Densford

Medtronic logo updated

Medtronic (NYSE:MDT) said today that it won expanded FDA approval for its Resolute drug-eluting stent platform, now cleared for treating patients with coronary artery disease and de novo chronic total occlusion. The new clearance covers the Resolute Onyx and Resolute Integrity devices, the Fridley, Minn.-based company said. “This expanded indication will allow physicians the option to treat […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Stents Tagged With: Medtronic

Biotronik wins FDA nod for Orsiro DES

February 22, 2019 By Fink Densford

Biotronik said today that it won FDA approval for its for its Orsiro drug-eluting stent, touting it as the first and only ultrathin DES to outperform Abbott‘s (NYSE:ABT) Xience. The Berlin, Germany-based company said that the approval came based on data from the BIOFLOW-V pivotal trial of the device. Results from the study indicated a significantly […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance, Stents Tagged With: Biotronik

How suppliers are taking drug-delivery tech to the next level

September 14, 2018 By Heather Thompson

ProMed Pharma medtech suppliers drug delivery tech

Medical device industry suppliers and outsourcers are helping to enable the latest drug-delivery tech. Drug-eluting technologies are moving beyond stents, thanks in part to the development of polymeric hydrogels engineered to respond to a range of different physical and chemical stimuli. Medtech innovators have figured out how to use hydrogels as components of micro-shells or […]

Filed Under: Contract Services, Discovery, Drug-Device Combinations, Featured, Hydrogels, Nanoparticles, Stents Tagged With: Freudenberg Sealing Technologies, freudenbergmedical, freudenbergmedicalhemoteq, lubrizol, promedpharma, Trelleborg, Trelleborg Sealing Solutions

MicroPort’s drug-eluting stent performs well in European study

September 4, 2018 By Nancy Crotti

MicroPort Scientific’s Firehawk rapamycin target eluting coronary stent performed comparably to Abbott’s Xience stent family in a study just published in The Lancet. The TARGET AC multi-center, randomized controlled trial enrolled 1,653 patients at 21 clinical study sites in Europe. Firehawk met the trial’s non-inferiority primary endpoint of target lesion failure rate at 12 months of 6.1% versus […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Implants, Stents, Uncategorized Tagged With: abbott, microportscientific

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