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.

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
June 7, 2021 — A couple years ago a study showed a mortality safety signal in patients who underwent peripheral artery...
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
May 20, 2021 — Boston Scientific Corporation announced it has initiated the AGENT IDE trial for the Agent Drug-Coated...
Videos | Cath Lab | March 31, 2021
This is a quick example of clinical use of the Shockwave Medical Intravascular Lithotripsy system that uses sonic wave...
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

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. You can see the cracks forming as the bead breaks apart in the right bead. 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 | March 16, 2021
After covering cardiovascular technologies for 14 years, it is rare that I find a new technology that might actually be...
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
The first devices developed for interventional cardiology were percutaneous transluminal coronary angioplasty (PTCA)...
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
March 12, 2021 — Philips Healthcare announced the final, five-year results of two major randomized controlled trials (...
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. 

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

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) | November 13, 2020
November 13, 2020 — The new U.S. Food and Drug Administration (FDA) cleared XO Score system was successfully used to...
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
November 3, 2020 — The U.S. Food and Drug Administration (FDA) has cleared the Boston Scientific Ranger Drug-coated...
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
October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benefit...
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
October 18, 2020 – The first results from the IN.PACT Below the Knee (BTK) Study, a feasibility study assessing the...
Videos | Drug-Eluting Balloons | September 09, 2020
Juan F. Granada, M.D., CEO of the Cardiovascular Research Foundation (CRF) worked on preclinical development work for a...
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.

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 | September 08, 2020
September 8, 2020 — Researchers developed a new class of medical instruments equipped with an advanced soft electronics...
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
Drug-coated balloons (DCB), also referred to as drug-eluting balloons (DEB), were created as a way to reduce very high...
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
July 7, 2020 – MedAlliance announced enrollment of the first patient in its study of Selution SLR 0.014 drug-eluting...