Balloon Catheter

This channel includes news and new technology innovations for angioplasty balloon catheters (PTA). These are used in arteries with atherosclerotic lesions to compress the plaque expand the artery lumen to reopen occluded or heavily stenosed atherosclerotic lesions. Balloons are often used in combination with a stent to prop the treated vessel segment open. In addition to plain old balloon angioplasty (POBA), this section includes news about drug-coated balloon (DCB), valvuloplasty balloons and specialty cutting balloon.

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

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While the current positive revolution in percutaneous coronary intervention (PCI) practice has been made possible by the wealth of technological advancements, bringing the necessary tools together in a streamlined workflow has remained a challenge for clinicians

Case Study | Baylor Scott and White Heart Hospital

Contemporary PCI: Utilizing State-of-the-Art Technology to Achieve the Best Outcomes

While the current positive revolution in percutaneous coronary intervention (PCI) practice has been made possible by the ...

May 05, 2023

Videos | Cath Lab

VIDEO: Example of Coronary Lithotripsy to Break up Calcified Lesion

This is a quick example of clinical use of the Shockwave Medical Intravascular Lithotripsy system that uses sonic wave ...

March 31, 2021

The Shockwave intravascular lithotripsy system produces a flash of light as it releases a sonic shockwave, as seen here as it is about to shatter a gypsum bead during a TCT 2019 demonstration at the vendor's booth. The technology combines a miniaturized lithotripsy system with a low-pressure balloon catheter to expand peripheral or coronary arteries without causing vessel trauma. Photo by Dave Fornell

Blog | Cath Lab

Coronary Lithotripsy May Become a Paradigm Shift in the Cath Lab

After covering cardiovascular technologies for 14 years, it is rare that I find a new technology that might actually be ...

March 16, 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

A comparison showing angiography and optical coherence tomography (OCT) views of an undilated mid right coronary artery calcified lesion, post dilation with the Shockwave intravascular lithotripsy system, and the final result after stenting. The technology allows calcified lesions to be broken up without the need for vessel trauma caused by high pressure balloons or atherectomy.

Feature | Balloon Catheter

FDA Clears Coronary Intravascular Lithotripsy to Breakup Calcified Lesions With Sound Waves

February 17, 2021 — The U.S. Food and Drug Administration (FDA) has cleared Shockwave Medical's Intravascular ...

February 17, 2021

The FDA-Cleared XO Score is different. XO Score technology allows users to convert basic angioplasty balloons in the hospital's existing inventory into sophisticated scoring, cutting, and infusion/delivery devices.

News | Peripheral Artery Disease (PAD)

New Angioplasty System Dilates Calcified and Fibrotic Vessels

November 13, 2020 — The new U.S. Food and Drug Administration (FDA) cleared XO Score system was successfully used to ...

November 13, 2020

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

A conformal array of flexible electrodes affixed to an inflated balloon catheter. The sensors have the ability to make measurements of temperature, force of contact and electrophysiological parameters, ability to customize diagnostic and therapeutic functions and offer real-time feedback. Photo by John Rogers, Northwestern University.

News | EP Lab

Flexible Electronics Mounted on Balloons May Improve Cardiac Catheter Ablation Procedures

September 8, 2020 — Researchers developed a new class of medical instruments equipped with an advanced soft electronics ...

September 08, 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