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.

The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES).

News | Drug-Eluting Balloons

MedAlliance’s SELUTION SLR Drug-eluting Balloon Receives FDA Investigational Device Exemption Approval

May 27, 2022 — The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a ...

May 27, 2022

Three 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 SCAI22.

News | Peripheral Artery Disease (PAD)

New Longterm Data of Paclitaxel Devices Continues to Show No Increased Mortality Compared to Non-drug Coated Devices

May 20, 2022 — New long-term data from the Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel ...

May 20, 2022

First multi-center, randomized controlled study provides the largest long-term evidence for the treatment of heavily calcified femoropopliteal lesions

News | Peripheral Artery Disease (PAD)

Disrupt PAD III Trial Demonstrates Safety and Effectiveness of Intravascular Lithotripsy for Peripheral Artery Calcification

May 19, 2022 — One year outcomes from the Disrupt PAD III Trial comparing intravascular lithotripsy (IVL) with a drug ...

May 19, 2022

In accordance with its commitment to patient safety, Medtronic recently voluntarily recalled a subset of its IN.PACT Admiral and IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility.

News | Drug-Eluting Balloons

Medtronic Issues Voluntary Recall for Subset of IN.PACT Admiral and IN.PACT AV Drug Coated Balloon

March 31, 2022 — In accordance with its commitment to patient safety, Medtronic recently voluntarily recalled a subset ...

March 31, 2022

Biosensors Rise non-compliant angioplasty balloon

News | Drug-Eluting Balloons

First-in-man Study Shows Effectiveness of of Biolimus Drug-coated Balloon in Small Coronary Vessels

November 10, 2021 — Biosensors International Group Ltd., a developer and manufacturer of innovative medical devices ...

November 10, 2021

The objective of this clinical investigation has been to evaluate safety and performance outcomes of SELUTION SLR, MedAlliance’s novel sirolimus-eluting balloon, for the treatment of long tibial occlusive lesions (TASC C & D) in patients with Critical Limb Ischemia (CLI). It was presented at VIVA 2021.

News | Drug-Eluting Balloons

18-Month Below-the-Knee Data With MedAlliance’s SELUTION SLR Presented at VIVA

October 20, 2021 — 18-month results from the PRESTIGE* Below-the-Knee (BTK) study have been presented as a late-breaking ...

October 20, 2021

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)

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 ...

June 07, 2021

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

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 ...

May 20, 2021

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.

Feature | Balloon Catheter | By Dave Fornell, Editor

Overview of Angioplasty Balloon Technology Advances

The first devices developed for interventional cardiology were percutaneous transluminal coronary angioplasty (PTCA) ...

March 16, 2021

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

News | Drug-Eluting Balloons

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 ...

March 12, 2021

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

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 ...

November 03, 2020

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

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 ...

October 18, 2020

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

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 ...

October 18, 2020

Videos | Drug-Eluting Balloons

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 ...

September 09, 2020

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 | 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 ...

August 06, 2020