Tag: DCB

dialysis access

Drug-coated balloons: A “first-line” treatment for stenosis and vascular access failure...

This advertorial is sponsored by Cardionovum® Matteo Tozzi (Varese, Italy) recently spoke to Vascular News about the role of drug-coated balloons (DCBs) in vascular access. The...

New data add to body of research demonstrating safety and effectiveness...

Results from two studies evaluating the utility of atherectomy for peripheral endovascular interventions have just been released as late-breaking data presentations at VIVA 2024...

TCT 2024: One-year data from SIRONA trial show similar results for...

Data from the prospective, multicentre, investigator-initiated SIRONA randomised clinical trial demonstrated MagicTouch (Concept Medical) sirolimus-coated balloons to be noninferior compared to paclitaxel-coated balloons with...
SOL Japan

First results of SOL Japan highlight “extraordinary performance” of Luminor DCB...

iVascular has announced that "outstanding" results from the SOL Japan study were recently presented at the Japan Endovascular Treatment (JET) conference (14–16 June, Fukuoka,...

Luminor anticipated to have a “big impact” on the Japanese market...

NOTE: This video is ONLY available to watch in selected countries and geographies Yoshimitsu Soga (Fukuoka, Japan) spoke to Vascular News at the Leipzig...

Long-term IN.PACT AV data show there is “definitely a place” for...

 Matteo Tozzi (Varese, Italy) and Kate Steiner (Stevenage, UK) sat down with Vascular News at this year’s Charing Cross (CX) International Symposium (23–25 April,...

“We know which DCB to use”—but many other questions remain in...

A first-time presentation at the 2024 Charing Cross (CX) International Symposium (23–25 April, London, UK) of five-year data from the IN.PACT AV Access study...
paclitaxel

CX 2024: Paclitaxel device restrictions “did cause harm”

“Unfortunately, we are doing worse for our patients today,” were the sobering thoughts of Eric Secemsky (Boston, United States) during a late-breaking presentation in...
biopact

Two-year BIOPACT randomised controlled trial analysis demonstrates “persistent excellence” for low-profile...

Biotronik has announced the presentation of two-year results from the investigator-initiated BIOPACT randomised controlled trial (RCT) by principal investigator Koen Deloose (AZ Sint-Blasius Hospital,...
Biotronik

Biotronik announces one-year subgroup results from BIOPACT RCT

Biotronik has announced one-year subgroup results from the investigator-initiated BIOPACT randomised controlled trial (RCT), which were presented by principal investigator Koen Deloose (AZ Sint-Blasius,...

Surmodics receives FDA approval for the SurVeil drug-coated balloon

Surmodics has announced the receipt of US Food and Drug Administration (FDA) approval for the SurVeil drug-coated balloon (DCB). A company press release notes that...
lutonix

“If we are going to use these devices, we have to...

Delivering first-release data, Scott O Trerotola (University of Pennsylvania, Philadelphia, USA) conveyed the “consistent results” in a real-world environment for the Lutonix arteriovenous (AV)...

DCBs are “first-line treatment for better outcomes” for typical vascular access...

NOTE: This video is ONLY available to watch in selected countries and geographies Could drug-coated balloons (DCBs) be “the perfect device” for the treatment...
dialysis access

The Aperto® drug-coated balloon: A “first-line” treatment for arteriovenous fistula lesions

This advertorial is sponsored by Cardionovum®. In 2023, there are a number of different options available for treating the vascular access complications of thrombosis and...

Cost effectiveness of urea-based DCB treatment for CLTI patients “extremely important”

 A range of experts, including Koen Deloose (Dendermonde, Belgium), Thomas Zeller (Bad Krozingen, Germany), Marianne Brodmann (Graz, Austria) and Antonio Micari (Messina, Italy), talk...

Experts react to “compelling” 36-month IN.PACT AV Access trial data

NOTE: This video is ONLY available to watch in selected countries and geographies Robert Shahverdyan (Hamburg, Germany), Matteo Tozzi (Varese, Italy), Alexandros Mallios (Paris,...

New study comparing DCBs to bare metal stents in femoropopliteal lesions...

 During a late-breaking clinical trials session at the 2022 Vascular Interventional Advances (VIVA) conference (31 October–3 November, Las Vegas, USA), Mehdi Shishehbor (University Hospitals...

VentureMed to present new data on DCB treatment for PAD

VentureMed Group has announced new data presentations on the treatment of peripheral arterial disease (PAD) with drug-coated balloon (DCBs) in addition to 12-month AV...

Chocolate Touch drug-coated angioplasty balloon for treatment of PAD receives FDA...

Genesis MedTech Group announced that the US Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA)...
SurVeil

SurVeil DCB demonstrates sustained durability of safety, efficacy endpoints in TRANSCEND

In the TRANSCEND clinical trial, the SurVeil drug-coated balloon (DCB; Surmodics) demonstrated "excellent efficacy and safety" out to 24-month follow-up. This is according to...

New data bolster safety and effectiveness of Safepax DCB coating technology

This advertorial is sponsored by Cardionovum®. DCB Matteo Tozzi, associate professor of Vascular Surgery at the University of Insubria (Varese, Italy), speaks to Vascular News...
Biotronik

New data on Biotronik’s Passeo-18 Lux DCB presented at LINC 2022

Biotronik recently announced the presentation of two studies on the performance of its drug-coated balloon (DCB) catheter Passeo-18 Lux at the Leipzig Interventional Course (LINC)...

Medtronic gains FDA approval for IN.PACT 018 DCB

Medtronic has announced approval from the US Food and Drug Administration (FDA) for the IN.PACT 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a...

First time data release: View the full IN.PACT AV Access trial...

NOTE: This video is ONLY available to watch in selected countries and geographies In a late-breaking Podium 1st presentation at the 2022 Charing Cross...

IN.PACT AV Access: Three-year data support use of paclitaxel-coated balloon as...

The 36-month results from the IN.PACT AV Access study (Medtronic)—which were presented for the first time during at the 2022 Charing Cross (CX) International...

Five-year patient-level data confirm safety of Passeo-18 Lux paclitaxel DCB

New long-term data presented at the 2022 Charing Cross (CX) Symposium (26–28 April, London, UK) demonstrate the safety of Biotronik’s Passeo-18 Lux paclitaxel drug-coated...

Evidence in the SFA: DES ‘will be the standard of care’...

NOTE: This video is ONLY available to watch in selected countries and geographies Marianne Brodmann (Medical University of Graz, Division of Angiology, Austria) talks...

Evidence in the SFA: Eluvia has a “significantly better” patency rate...

NOTE: This video is ONLY available to watch in selected countries and geographies Gunnar Tepe (interventional radiologist, Germany) discusses the results and subsequent impact...

Evidence in the SFA: Considering the data when making decisions for...

NOTE: This video is ONLY available to watch in selected countries and geographies  Koen Deloose (vascular surgeon, Belgium) looks at the evidence needed in order...

Evidence in the SFA: What kind of stent should we use?

NOTE: This video is ONLY available to watch in selected countries and geographies Antonio Micari (interventional cardiologist, Italy) gives his thoughts on the EMINENT...

Evidence in the SFA: Best strategy for treatment of the femoropopliteal...

NOTE: This video is ONLY available to watch in selected countries and geographies  Yann Goueffic (vascular surgeon, France) discusses the evidence that is needed...
AV access

IN.PACT Admiral DCB performs well across wide range of clinical and...

In a pooled analysis of the predictors of drug-coated balloon (DCB) effectiveness, the IN.PACT Admiral DCB (Medtronic) performed well across a broad range of...

VIVA 2021: IN.PACT Admiral DCB found to provide “high five-year freedom...

Real-world data drawn from the IN.PACT Global study looking at five-year freedom from clinically-driven target lesion revascularisation (TLR) among prespecified chronic total occlusion (CTO),...

Two-year Ranger DCB data demonstrate “sustained, high rate” of device efficacy

Patients treated with the Ranger drug-coated balloon (DCB; Boston Scientific) sustained “improved primary patency” with fewer reinterventions than those treated with uncoated devices, two-year...

Latest meta-analysis on paclitaxel in peripheral arterial disease provokes mixed reception

“There appears to be heightened risk of major amputation after use of paclitaxel-coated balloons in the peripheral arteries,” findings from a systematic review...
magictouch scb

Concept Medical provides update on IMPRESSION trial to evaluate MagicTouch AVF

Concept Medical has provided an update on the progress of the IMPRESSION (Sirolimus-coated balloon angioplasty versus plain balloon angioplasty in the treatment of dialysis...
trerotola misra tan av access dcbs drug coated balloons

More mixed results for DCBs in AV access maintenance as evidence...

Additional randomised controlled data regarding the effectiveness of drug-coated balloons (DCBs) in maintaining arteriovenous (AV) access offers new evidence, but it is freighted with...

Episode 2: Are all peripheral drug-coated balloons created equal?

 “Not all Drug-Coated Balloons (DCBs) are created equal”, Juan Granada (New York, USA), tells Vascular News in this second episode of a five-part series on the history of DCBs. Granada discusses why there...

Episode 1: Go behind the scenes to delve into the birth...

 To mark the 20-year anniversary of drug-coated balloons, Bruno Scheller (Homburg/Saar, Germany) and Gunnar Tepe (Rosenheim, Germany), talk to Vascular News about their contributions...

‘Indisputable evidence’ that DCB is the “gold standard” for treating vascular...

NOTE: This video is ONLY available to watch in selected countries and geographies Tobias Steinke (Düsseldorf, Germany), Matteo Tozzi (Varese, Italy) and Robert Shahverdyan...

CONSEQUENT study shows low mortality and TLR rates in PAD patients...

NOTE: This video is ONLY available to watch in selected countries and geographies Ralf Langhoff (Berlin, Germany) talks to Vascular News about the 12-month...
everolimus

Cardiovascular Systems and Chansu Vascular Technologies partner to develop new everolimus...

Cardiovascular Systems (CSI) has partnered with Chansu Vascular Technologies (CVT) to develop novel peripheral and coronary everolimus drug-coated balloons (DCBs). Under the terms of the...

COMPARE trial shows low dose DCB is “as safe and efficacious”...

 Sabine Steiner (Leipzig, Germany) talks to Vascular News about the 24-month results from the COMPARE trial – which were presented at LINC 2021 (The...
PAVE

PAVE trial finds “no evidence of a benefit” from paclitaxel-coated balloons...

There is no evidence of a benefit from additional paclitaxel-coated balloon use compared to standard balloon angioplasty alone in the context of preserving arteriovenous...

New England Journal Of Medicine publishes “outstanding” six-month IN.PACT AV Access™...

NOTE: This video is ONLY available to watch in selected countries and geographies Robert Lookstein (New York, USA; principal investigator) and Andrew Holden (Auckland,...

ILLUMENATE four-year pooled analysis has “brought increased clarity” to the paclitaxel...

 Sean Lyden (Cleveland, USA), current VIVA Board president, speaks to Vascular News about his two years at the helm, which began with the “controversy on...

Real-world data with long-term follow-up confirm no increased mortality signal with...

Data from an unselected, real-world cohort of 64,000 claimants of the German BARMER Health Insurance reveals no signal of increased long-term mortality when paclitaxel-based...

Impressions from LINC 2020: Strong clinical and economic case for widespread...

NOTE: This video is ONLY available to watch in selected countries and geographies Andrew Holden (Auckland, New Zealand), Alexandros Mallios (Paris, France), Robert Lookstein (New...
Ramon Varcoe

New meta-analysis finds “no observed difference” in mortality between paclitaxel and...

February 2020 brings another paclitaxel device meta-analysis of randomised controlled trials in chronic limb-threatening ischaemia (CLTI) patients. Krystal Dinh (Westmead Hospital, Sydney, Australia) et...

LINC 2020: Real-world evidence shows no increased mortality signal with paclitaxel-coated...

 Dierk Scheinert (Leipzig, Germany) moderates a panel with Eva Freisinger (Münster, Germany) and Thomas Zeller (Bad Krozingen, Germany) to discuss the developments over the...

COMPARE RCT shows similar key outcomes between low- and high-dose drug-coated...

The first head-to-head randomised controlled trial to directly compare two different drug-coated balloons—the lower-dose density (2μg/mm2) Ranger and higher-dose density (3.5μg/mm2) IN.PACT—showed similar results...
Panel at LINC Tuesday MEDTRONIC

LINC 2020: One year IN.PACT AV results show sustained patency benefit...

NOTE: This video is ONLY available to watch in selected countries and geographies  The one-year IN.PACT AV trial results, first presented at LINC 2020 (28–31 January, Leipzig,...
Breaking news in healthcare meta-analysis-paclitaxel-katsanos

Hotly-contested meta-analysis suggests a higher risk of death or amputation at...

A new meta-analysis, just published in the Journal of Vascular and Interventional Radiology (JVIR), suggests significantly worse amputation-free survival at one year with the...

Vascular surgeons and cardiologists respond to new meta-analysis of PCBs in...

Eminent vascular surgeons and interventional cardiologists including Kim Hodgson (Springfield, USA), Ramon Varcoe (Sydney, Australia) and Gary Ansel (Columbus, USA) give their thoughts on...

IR experts respond to new meta-analysis of paclitaxel-coated balloons in infrapopliteal...

 A range of interventional radiology experts including Michael Dake (Tucson, USA), John Kaufman (Portland, USA), Jim Reekers (Amsterdam, The Netherlands) and Gunnar Tepe (Rosenheim,...

LUMBRA, real-world study of Luminor DCB in Brazil, commences

A real-world study investigating the luminor drug-coated balloon (DCB; iVascular) in Brazil has started, following approval for commercialisation of the device by ANVISA, the...

VIVA 2019: Boston Scientific announces positive data for the Ranger DCB...

Boston Scientific today announced positive data for two devices within the peripheral drug-eluting product portfolio during separate late-breaking clinical trial presentations at the 2019...
Lutonix

BD announces publication of drug-coated balloon safety data for femoropopliteal PAD

BD has announced the publication of a company-initiated, independent analysis of the Lutonix 035 drug-coated balloon (DCB) femoropopliteal clinical programme in the Journal of...

Experts discuss latest results from EFFPAC and TINTIN trials presented at...

NOTE: ONLY intended for healthcare professionals outside of the USA. Ulf Teichgräber (Jena, Germany) and Koen Deloose (Dendermonde, Belgium) discuss the 24-month results of the...
AV access

CIRSE 2019: IN.PACT AV access trial meets primary safety and effectiveness...

Medtronic has announced the first-ever results from the IN.PACT AV access clinical study comparing the investigational IN.PACT AV drug-coated balloon (DCB) to percutaneous transluminal...
Motiv

MagicTouch PTA sirolimus coated balloon granted breakthrough device designation by FDA

Concept Medical has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for its MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus...

Interim results of a multicentre analysis support paclitaxel-coated balloon angioplasty

The interim results of a multicentre, European retrospective analysis investigating the use of drug-coated balloons (DCBs) in symptomatic central venous stenosis (CVS) suggest that...

Webinar: Safety of paclitaxel devices—What does the evidence say?

Jos van den Berg (Lugano, Switzerland), Antonio Micari (Bergamo, Italy) and Marianne Brodmann (Graz, Austria) sit down after a specially convened US FDA panel...
Lutonix

BD receives FDA approval for expansion to drug-coated balloon product line

The US Food and Drug Administration (FDA) has approved expanded sizes of the Lutonix 018 drug-coated balloon (DCB) to treat long superficial femoral artery...

Two-year trial data show “astonishing results” for luminor DCB

Ulf Teichgräber (Jena, Germany), talks to Vascular News at EuroPCR 2019 about the EFFPAC trial which compared the luminor (iVascular) drug-coated balloon (DCB) with...
ILLUMENATE

Late-breaking ILLUMENATE data demonstrate three-year safety and efficacy for Stellarex DCB

Three-year results from the ILLUMENATE Pivotal trial and the ILLUMENATE European randomised controlled trial (EU RCT) have been presented in a late-breaking trial session...

Sirolimus has “a much wider” safety window and shows fewer local...

 "Paclitaxel kills the cells in the artery wall; sirolimus simply stuns them," says Peter Gaines (Sheffield, UK). Gaines commented at the 2019 Vascular Leaders...

Customising therapy in femoropopliteal revascularisation

 Gary Ansel (Columbus, USA) tells Vascular News at VEITHSymposium 2018 about how drug-based therapies have become a mainstay in femoropopliteal revascularisation and how interventionalists...

Patient-level analysis shows no correlation between paclitaxel and mortality—reactions from LINC

 Renowned experts expressed confidence in the continued use of paclitaxel-coated devices after independent patient-level data presented at LINC 2019 did not show correlation between...

New data release at LINC 2019 reinforces safety profile of low-dose...

 Sean Lyden (Cleveland, USA) and Fabrizio Fanelli (Rome, Italy) discuss the safety and future of drug-coated balloons (DCB) in light of the latest pooled...
paclitaxel

Meta-analysis finds a higher risk of death in the long term...

New data, just published in the Journal of the American Heart Association (JAHA), suggest that there is an increased risk of death at two...

Lutonix BTK IDE: First Level 1 evidence of positive safety and...

 Patrick Geraghty (St Louis, USA) presented new datapoints from the six-month outcomes of the Lutonix BTK IDE trial at the 2018 VEITHsymposium (13–17 November,...

Lutonix 014 DCB gathers first randomised evidence of positive safety and...

Six-month outcomes of the Lutonix BTK IDE trial, a multicentre randomised controlled trial using the Lutonix 014 drug-coated balloon (DCB; BD), has demonstrated that...

TOBA II shows repairing dissections after angioplasty “clearly augments” outcomes for...

Thomas Zeller (Bad Krozingen, Germany) delves into data and design of the TOBA II (Tack Optimized Balloon Angioplasty II) trial with principal investigator William...

Live from CIRSE 2018: Three-year results from global study confirm the...

The largest prospective, independently-adjudicated study of drug coated balloons (DCBs) in a broad range of lesions in real-world patients confirms the safety and performance...

Terumo gets CE mark for Kanshas drug-coated balloon catheter for lower...

Terumo has announced that it acquired CE mark for the Kanshas drug-coated balloon catheter used in the treatment of lower extremity peripheral arterial disease....

New CMS reimbursement code “severely underpays” for drug-coated balloons

Drug-coated balloon (DCB) angioplasty devices have been categorised by the US Centers for Medicare and Medicaid Services (CMS) into the same billing code as...

First look at the interim LUTONIX DCB AV registry data

Vascular News interviews Panos Kitrou, Patras University Hospital, Rio, Greece, on the interim data from the LUTONIX DCB AV registry trial. The data were presented...

First data from head-to-head comparison of Ranger and IN.PACT drug-coated balloons...

Early data from the first randomised controlled trial to compare two drug-coated balloons (DCBs) suggest that the primary patency obtained with the Ranger DCB...
Medtronic IN.PACT Admiral

LINC 2018 data highlight IN.PACT Admiral as safe and effective treatment...

Medtronic added to its body of clinical evidence supporting the IN.PACT Admiral drug-coated balloon with new presentations that demonstrated durable and consistent clinical outcomes...
Surmodics

First patient enrolled in TRANSCEND trial for SurVeil DCB

Surmodics has announced enrolment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil drug-coated balloon (DCB). The randomised trial will evaluate...
BIBLIOS

Luminor drug-coated balloon receives Canadian Medical Device Licence

iVascular has announced that its Luminor 14m peripheral balloon catheter with paclitaxel elution has received the Canadian Medical Device Licence (MDL). Luminor 14m is a...

Data from multiple studies support concept of low metal burden therapies...

Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce restenosis rates, according to results from various Biotronik studies...

Luminor EffPAC study shows efficacy at six months

Data have been announced demonstrating the efficacy of iVascular’s Luminor drug-coated balloon (DCB) in patients with peripheral artery disease (PAD) at six months. The...

Two-year efficacy of Philips’ Stellarex 0.035” low-dose drug-coated balloon demonstrated

Philips has announced the two-year results from the ILLUMENATE European randomised clinical trial (EU RCT) demonstrating the efficacy of the Philips Spectranetics’ Stellarex 0.035”...
Surmodics

Encouraging 100% primary patency and improved quality-of-life scores at six months...

Data from the Surmodics PREVEIL early feasibility study of the company’s SurVeil drug-coated balloon (DCB) was shared in a late-breaking clinical trial presentation at...

Two- and four-year IN.PACT Admiral drug-coated balloon data indicate good mid-...

Medtronic has released data reinforcing the durability and safety of the IN.PACT Admiral drug-coated balloon (DCB) in patients with peripheral artery disease (PAD). The...
IN.PACT

IN.PACT Admiral drug-coated balloon is approved in Japan

Medtronic announced on 8 September 2017 that the IN.PACT Admiral drug-coated balloon (DCB) received approval from the Japanese Ministry of Health, Labour and Welfare...

RD Global-Invamed receives CE mark to market Extender DCB and Temren...

RD Global-Invamed has announced it has received CE marking to market the Extender drug-coated balloon (DCB) and Temren atherectomy with CTO catheter for treating...

CMS drug-coated balloon reimbursement code to expire in December

December 2017 will mark an important change in to US Medicare reimbursement for drug-coated balloons (DCBs) which could create an access barrier to DCB...

Bard gets FDA premarket approval of the Lutonix 035 DCB for...

Bard’s Lutonix 035 drug-coated balloon PTA catheter (DCB) has been granted premarket approval (PMA) by the US Food and Drug Administration (FDA) for a...

Enrolment begins in US pivotal study of Chocolate Touch

QT Vascular has started enrolment in its US pivotal clinical study. The study will evaluate the company's Chocolate Touch drug-coated balloon (DCB), for use in...
Surmodics

Surmodics receives IDE approval to initiate SurVeil drug-coated balloon pivotal trial

Surmodics has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the...
IN.PACT

IN.PACT Admiral approved for reimbursement in France and Belgium

Medtronic has announced recent reimbursement approvals in both France and Belgium. A Ministerial decree was published in the Official Journal of French Republic to enlist...

Lutonix for dysfunctional arteriovenous fistulae shows improved primary patency vs. plain...

Interim twelve-month data from the Lutonix AV Clinical Trial indicate that treatment of dysfunctional arteriovenous (AV) fistulae with Bard’s Lutonix drug-coated balloon (DCB) produces...
IN.PACT

Japanese IN.PACT SFA study demonstrates clinical outcomes consistent with other trials

The one-year clinical outcomes from the MDT-2113 IN.PACT SFA Japan trial have been released. The data was recently presented by Osamu Iida, Kansai Rosai...

LUMINOR Registry may help “reopen the door” for drug-coated balloons below...

The LUMINOR Registry is a real-world prospective multicentre study evaluating iVascular’s Luminor paclitaxel-eluting balloon for treating advanced limb ischaemia. Vascular News spoke to Vincent...

Promising early results for Lutonix US IDE trial in obstructed AV...

The first US randomised controlled trial for drug-coated balloon use for arteriovenous fistula obstructions for 50 years, the Lutonix (Bard) IDE trial was a...

First randomised Stellarex DCB data show 12-month outcomes superior to percutaneous...

Marianne Brodmann of Medical University Graz, Austria, has presented the final 12-month results of the Stellarex (Spectranetics) ILLUMENATE drug-coated balloon European randomised clinical trial...

REALITY trial enrols first patient in study evaluating Medtronic directional atherectomy...

Medtronic and VIVA Physicians reported on 27 July 2016 the first patient enrolled in the REALITY Study. The VIVA-sponsored study is assessing outcomes for...

UK NICE publishes Medtech Innovation Briefing on Lutonix

The UK National Institute for Health and Care Excellence (NICE) has developed a Medtech Innovation Briefing (MIB) on the Lutonix drug-coated balloon (DCB) for...