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Biotronik

Medtech manufacturers must add warning label to drug-eluting PAD devices

June 16, 2020 By Nancy Crotti

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 late death compared […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Regulatory/Compliance, Vascular Tagged With: B. Braun Medical, Biosensors International, Biotronik, Boston Scientific, cook medical, FDA, Lutonix, LVD Biotech, Medtronic, Spectranetics, UK Medicines and Healthcare products Regulatory Agency

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

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

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

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

Statistical error reverses noninferiority finding in head-to-head trial of DES, bioresorbable scaffold

December 4, 2018 By Sarah Faulkner

Biotronik's Orsiro

In a reversal, investigators for a trial comparing Biotronik‘s bioresorbable, drug-eluting Orsiro stent and Biosensors‘ BioFreedom drug-eluting stent reported this week that Biosensors’ device did not meet the criteria for noninferiority. The researchers said that while preparing the study for publication in a journal, they discovered a statistical error that ultimately changed the trial’s conclusion. […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular Tagged With: biosensors, Biotronik

TCT 2018: Boston Scientific wins FDA nod for drug-eluting vascular stent

September 24, 2018 By Sarah Faulkner

Boston Scientific

On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia. The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year. “Over the past decade, we’ve […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Vascular, Wall Street Beat Tagged With: abbott, biosensors, Biotronik, Boston Scientific, cook medical, Medtronic, TCT 2018

Biotronik touts two-year study comparing drug-eluting stents

May 25, 2018 By Sarah Faulkner

Biotronik yesterday presented two-year data from a trial comparing Boston Scientific‘s (NYSE:BSX) Synergy biodegradable polymer everolimus-eluting stent, Biotronik’s Orsiro sirolimus-eluting stent and Medtronic‘s (NYSE:MDT) Resolute Integrity zotarolimus-eluting stent. Results from the 3,514-patient trial showed no significant difference between the various stents regarding the rate of target vessel failure after two years. But analyses of one-year data found differences between the rates of […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular, Wall Street Beat Tagged With: Biotronik, Boston Scientific, Medtronic

Medtech stories we missed this week: April 6, 2018

April 6, 2018 By Danielle Kirsh

missed-medtech-0406

From CHF Solutions’s distribution deal to Guided Therapeutics’s licensing agreement, here are seven medtech stories we missed this week but throught were still worth mentioning. 1. CHF inks Spanish distribution deal CHF Solutions announced in an April 5 press release that it has signed a distribution agreement with Dimedix Surgical. The distribution agreement will allow […]

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, Imaging, Implants, Regulatory/Compliance Tagged With: asahiintecc, aziyobiologics, Biotronik, chfsolutions, Guided Therapeutics, hypermed, instrumedsurgical, johnsonandjohnson, medtech, NanoVibronix

Biotronik’s Orsiro drug-eluting stent succeeds at five-year follow-up

November 2, 2017 By Sarah Faulkner

Biotronik's Orsiro

Biotronik touted long-term safety and efficacy data for its Orsiro drug-eluting stent yesterday at this year’s Transcatheter Cardiovascular Therapeutics meeting. Data from the Bioflow-II trial and the Bioflow-III registry demonstrated that Biotroniks’s device boasts strong safety and clinical performance at five years, the company reported. In the 268-patient group treated with Orsiro, 60-month data from […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Stents, Vascular, Wall Street Beat Tagged With: abbott, Biotronik

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