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Cardiovascular

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

Medtronic’s In.Pact AV DCB meets endpoints in trial

September 9, 2019 By Sean Whooley

Medtronic logo updated

Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints. The study pitted the In.Pact AV DCB against PTA in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. Results were presented at the Cardiovascular and Interventional Radiology Society […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Research & Development, Vascular Tagged With: Medtronic

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

B. Braun wins breakthrough nod for drug-coated balloon catheter

August 2, 2019 By Nancy Crotti

The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company’s SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter for the treatment of coronary in-stent restenosis (ISR). The designation follows 10 years of clinical studies on the SeQuent Please drug-coated PTCA catheters, with data reported in peer-reviewed articles, according to the […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Uncategorized Tagged With: B. Braun Interventional Systems, FDA

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

FDA updates docs on review of paclitaxel devices for PAD

March 18, 2019 By Sarah Faulkner

FDA-logo-new

The FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices. In a letter to healthcare providers, the U.S. regulatory agency reported that there was […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Vascular Tagged With: FDA

Medtronic updates on corrected safety analysis for paclitaxel-coated balloon

March 4, 2019 By Sarah Faulkner

Medtronic logo updated

Medtronic (NYSE:MDT) said last week that a revised safety analysis of its In.Pact drug-coated balloon has been accepted by the Journal of the American College of Cardiology. Last month, the medtech titan reported that a programming error inadvertently caused mortality data to be omitted from a statistical analysis involving the company’s paclitaxel-coated balloon. The announcement came […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Vascular, Wall Street Beat Tagged With: Medtronic

Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent

February 21, 2019 By Sarah Faulkner

Cook Medical - updated logo

The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors. In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular Tagged With: Boston Scientific, cook medical, Medtronic

Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis

February 19, 2019 By Sarah Faulkner

Medtronic logo updated

Medtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons. The company noted that the mistake ultimately does not affect the conclusion that there was no statistically significant difference in all-cause mortality between its In.Pact Admiral drug-coated balloon and plain balloon angioplasty at five […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: Medtronic

West Pharma’s SmartDose will deliver scPharmaceuticals’ edema drug

February 12, 2019 By Nancy Crotti

scPharmaceuticals

scPharmaceuticals’ (NSDQ:SCPH) has signed a development agreement to incorporate West Pharmaceutical Services’ (NYSE:WST) SmartDose drug delivery system with Furoscix, a drug that scPharmaceuticals developed to treat edema in heart failure patients. Burlington, Mass.-based scPharmaceuticals recently completed preliminary feasibility studies of the drug-device combination. The testing included drug stability in the pre-filled cartridge, drug compatibility, and […]

Filed Under: Business/Financial News, Cardiovascular, Drug-Device Combinations, Uncategorized Tagged With: scPharmaceuticals, West Pharmaceutical Services

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