Drug-Eluting Balloons

This channel includes news and new technology innovations for drug-coated balloons (DCB), also referred to as drug-eluting balloons. These are used to treat peripheral and coronary artery lesions and restenosis. The balloons carry an antiproliferative drug that is delivered to the wall of arteries when the balloon is expanded. The drug helps prevent neointimal hyperplasia (scar tissue growth) caused by trauma when the vessel segment is treated for atherosclerotic lesions with balloon angioplasty. DCBs can be used to treat hyperplasia in arteriovenous (AV) access fistulae in dialysis patients, where the vessel undergoes repeated trauma from regular punctures. DCBs also are used to treat in-stent restenosis due to scar tissue proliferation inside stents, which can cause a vessel to occlude.

Two years ago a study raised concerns that paclitaxel-coated devices may cause increased mortality in peripheral artery disease patients. However, numerous studies now show there is no risk of increased mortality. The most recent study is the SAFE-PAD study presented at ACC.21.

Two years ago a study raised concerns that paclitaxel-coated devices may cause increased mortality in peripheral artery disease patients. However, numerous studies now show there is no risk of increased mortality. The most recent study is the SAFE-PAD study presented at ACC.21.

News | Peripheral Artery Disease (PAD) | June 07, 2021
SAFE-PAD Study Shows No Safety Issues With Paclitaxel-coated Devices In Peripheral Artery Disease
June 7, 2021 — A couple years ago a study showed a mortality safety signal in patients who underwent peripheral artery...
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AGENT IDE will evaluate the AGENT DCB as potential therapy for patients with in-stent restenosis, may offer alternative to repeated stenting or radiation therapy
News | Balloon Catheter | May 20, 2021
Boston Scientific Initiates First Coronary Drug-Coated Balloon Study in the U.S.
May 20, 2021 — Boston Scientific Corporation announced it has initiated the AGENT IDE trial for the Agent Drug-Coated...
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Example of an angioplasty balloon catheter being expanded inside an artery to push atherosclerotic plaque and thrombus out of the way to reopen the vessel lumen to increase or reopen bloodflow. Balloon catheters are used to revascularize patients with heart attacks and to deploy stents to prop open the expended vessel.

Getty Images

Feature | Balloon Catheter | March 16, 2021 | By Dave Fornell, Editor
Overview of Angioplasty Balloon Technology Advances
The first devices developed for interventional cardiology were percutaneous transluminal coronary angioplasty (PTCA)...
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The Philips Stellarex low-dose paclitaxel drug-coated balloon prior to insertion in the cath lab. Five-year ILLUMENATE EU RCT and Pivotal Data Confirm Safety of Philips Stellarex Low-dose Drug-coated Balloon

The Philips Stellarex low-dose paclitaxel drug-coated balloon prior to insertion in the cath lab.

News | Drug-Eluting Balloons | March 12, 2021
Five-year ILLUMENATE EU RCT and Pivotal Data Confirm Safety of Philips Stellarex Low-dose Drug-coated Balloon
March 12, 2021 — Philips Healthcare announced the final, five-year results of two major randomized controlled trials (...
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The U.S. Food and Drug Administration (FDA) has cleared the Boston Scientific Ranger Drug-coated Balloon, developed for the treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).  
News | Drug-Eluting Balloons | November 03, 2020
FDA Clears Boston Scientific Ranger Drug-coated Balloon
November 3, 2020 — The U.S. Food and Drug Administration (FDA) has cleared the Boston Scientific Ranger Drug-coated...
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A large subgroup analysis of the VOYAGER PAD randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) in the treatment of peripheral artery disease (PAD). The study also found that the benefit of rivaroxaban use on reducing ischemic limb and cardiovascular outcomes was consistent regardless of whether a DCD was used. #TCT2020 #TCTconnect
Feature | Cath Lab | October 18, 2020
No Mortality Risk Associated With Paclitaxel-coated Devices Used to Treat Peripheral Artery Disease
October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benefit...
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The first results from the IN.PACT Below the Knee (BTK) Study, a feasibility study assessing the safety and effectiveness of the Medtronic  IN.PACT 0.014 drug-coated balloon (DCB) in critical limb ischemia (CLI) subjects with chronic total occlusion (CTO) in the infrapopliteal arteries. The data were presented in the Late-Breaking Clinical Trial Sessions at 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect virtual symposium of the Cardiovascular Research Foundation (CRF). #TCTconnect #TCT2020
News | Drug-Eluting Balloons | October 18, 2020
Drug-coated Balloon for Challenging Below-the-Knee Disease Shows Promise in Patients with Critical Limb Ischemia
October 18, 2020 – The first results from the IN.PACT Below the Knee (BTK) Study, a feasibility study assessing the...
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Videos | Drug-Eluting Balloons | September 09, 2020
VIDEO: Overview of Drug-coated Balloons
Juan F. Granada, M.D., CEO of the Cardiovascular Research Foundation (CRF) worked on preclinical development work for a...
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The Philips Healthcare Stellarex drug-coated balloon (DCB). It is cleared for use in peripheral vessels and treatment of failing AV access.

The Philips Healthcare Stellarex drug-coated balloon (DCB). It is cleared for use in peripheral vessels and treatment of failing AV access.

Feature | Drug-Eluting Balloons | August 06, 2020 | Dave Fornell, Editor
Recent Developments in Drug-Coated Balloons
Drug-coated balloons (DCB), also referred to as drug-eluting balloons (DEB), were created as a way to reduce very high...
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MedAlliance announced enrollment of the first patient in its study of Selution SLR 0.014 drug-eluting balloon (DEB) for the treatment of in-stent restenosis (ISR). This is the first DEB accepted by the FDA for its breakthrough program. The Selution SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).
News | Drug-Eluting Balloons | July 07, 2020
World’s First FDA IDE Coronary Patient Treated With a Drug-eluting Balloon
July 7, 2020 – MedAlliance announced enrollment of the first patient in its study of Selution SLR 0.014 drug-eluting...
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Comparison Charts
Drug-Coated Balloons
Drug-coated balloons (DCB), also referred to as drug-eluting balloons, are used to treat peripheral and coronary artery...
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iVascular Launches Essential Pro Coronary Drug-coated Balloon
News | Drug-Eluting Balloons | June 19, 2020
iVascular Launches Essential Pro Coronary Drug-coated Balloon
June 19, 2020 — iVascular SLU announced the global launch of Essential Pro, a novel coronary artery drug-coated balloon...
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MedAlliance announced its second CE mark approval for its Selution SLR 0.014 percutaneous transluminal coronary angioplasty (PTCA) sirolimus drug-eluting balloon (DEB) for the treatment of coronary artery disease. This includes indications for both de-novo lesions as well as in-stent restenosis. The approval applies to a broad range of balloon sizes, from 1.5 x 10 mm, up to 5 x 40 mm.
News | Drug-Eluting Balloons | June 18, 2020
MedAlliance Sirolimus Drug Eluting Balloon Gains Second European CE Mark
June 17, 2020 — MedAlliance announced its second CE mark approval for its Selution SLR 0.014 percutaneous transluminal...
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MedAlliance has announced the award of its second European CE mark clearance for its Selution SLR 0.014 percutaneous transluminal coronary angioplasty (PTCA) sirolimus drug-eluting balloon (DEB), for the treatment of coronary arterial disease. This includes indications for both de-novo lesions as well as in-stent restenosis.
News | Drug-Eluting Balloons | May 28, 2020
MedAlliance Gains European Clearance for Coronary Drug Eluting Balloon
May 28, 2020 – MedAlliance has announced the award of its second European CE mark clearance for its Selution SLR 0.014...
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The FDA cleared the IN.PACT AV drug-coated Balloon. Clinical data shows In.Pact AV DCB is Safe, reduces reinterventions and maintains access for end-stage renal disease patients undergoing dialysis
News | November 26, 2019
FDA Clears Medtronic Drug-Coated Balloon to Treat Arteriovenous Fistula Lesions
November 21, 2019 — The U.S. Food and Drug Administration (FDA) has cleared the Medtronic In.Pact AV drug-coated...
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