• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Peripheral Artery Disease

BD to shutter Minnesota Lutonix plant, layoffs ahead for 53

October 10, 2019 By Brad Perriello

Becton Dickinson (NYSE:BDX) is planning to close a Minnesota plant that makes its Lutonix drug-coated balloon next year, as the company looks to consolidate its peripheral intervention business. The decision means layoffs for 53 of the New Hope, Minn., site’s 85 workers; the remaining 32 employees will either move to roles at BD’s Tempe, Ariz., location […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured Tagged With: Becton Dickinson, Peripheral Artery Disease

Surmodics reaps $10m from Abbott on SurVeil balloon milestone

August 28, 2019 By Sean Whooley

SurModics

Surmodics (NSDQ:SRDX) said today that it’s due for a $10 million milestone payment from Abbott (NYSE:ABT) after closing enrollment for the Transcend pivotal trial of its SurVeil drug-coated balloon for treating peripheral artery disease. Abbott in February 2018 paid $25 million up front for the global commercialization rights to the SurVeil device, which uses a proprietary […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Funding Roundup, Wall Street Beat Tagged With: abbott, Medtronic, Peripheral Artery Disease, SurModics Inc.

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

FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices

June 20, 2019 By Brad Perriello

FDA

Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel’s chairman calling the data “a smoking gun, but no bullet or dead bodies at this particular point.” A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Becton Dickinson, Boston Scientific, Medtronic, Peripheral Artery Disease

FDA: More data needed on paclitaxel devices

June 19, 2019 By Brad Perriello

FDA

More data is needed on devices that elute the drug paclitaxel to determine if they pose a higher mortality risk than non-eluting devices in treating peripheral artery disease, the FDA said ahead of an advisory panel meeting today. A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated balloons […]

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

Cook Medical wins FDA nod for 5mm Zilver PTX stent

September 24, 2018 By Brad Perriello

Cook Medical's Zilver PTX 5mm

Cook Medical said it won FDA approval for a smaller-diameter version of its Zilver PTX peripheral drug-eluting stent. Bloomington, Ind.-based Cook said the approval for the 5mm diameter Zilver PTX makes it the first such stent up to 140mm that’s approved in the U.S. for vessels as small as 4mm. “We spend a lot of time […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: cook medical, Peripheral Artery Disease

FDA approves clinical trial for QT Vascular’s Chocolate Touch DCB

September 20, 2016 By Sarah Faulkner

QT Vascular

QT Vascular said today that it won an investigational device exemption from the FDA for a pivotal study of its Chocolate Touch drug-coated balloon. The device won the CE Mark for treating peripheral artery disease in September 2015 and in July it won approval for treating coronary artery disease. The Singapore-based company is slated to […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: AngioScore Inc., Peripheral Artery Disease, QT Vascular

FDA approves 6-month endpoint in trial of Bard’s Lutonix 014 drug-coated balloon

September 20, 2016 By Brad Perriello

C.R. Bard

C.R. Bard (NYSE:BCR) said yesterday that the FDA approved a supplemental investigational device exemption to change the main 6-month endpoint in the clinical trial of a new version of its Lutonix drug-coated balloon in treating below-the-knee peripheral arterial disease. Murray Hill, N.J.-based Bard in October 2014 won pre-market approval from the FDA for the Lutonix 035 DCB for PAD lesions above the […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured Tagged With: C.R. Bard, Peripheral Artery Disease

SurModics launches 1st-in-human trial for SurVeil drug-coated balloon

April 6, 2016 By Brad Perriello

SurModics (NSDQ:SRDX) said it enrolled the 1st patient in an early feasibility trial of its SurVeil drug-coated balloon for treating peripheral artery disease, as it looks to metamorphose from device coating provider to medical device maker. The FDA granted investigational device exemption for the trial late last year, the Eden Prairie, Minn.-based company said. The […]

Filed Under: Clinical Trials, Drug-Device Combinations Tagged With: Peripheral Artery Disease, SurModics Inc.

Covidien launches 2 trials to support its Stellarex drug-device combo

July 17, 2013 By drugdelivery

Covidien launched 2 trials to support its Stellarex drug-device combo

Covidien (NYSE:COV) kicked off 2 new clinical trials this week to support a global evaluation of its Stellarex drug-coated angioplasty balloon.

Filed Under: Clinical Trials, Drug-Device Combinations Tagged With: Clinical Trials, Covidien, Peripheral Artery Disease

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS