Tag: DCB

LUMIFOLLOW

LUMIFOLLOW one-year outcomes show efficacy for femoropopliteal lesions

Luminor (iVascular) drug-coated balloon (DCB) has confirmed its excellent safety and efficacy in femoropopliteal lesions with new study LUMIFOLLOW, a recent press release states. iVascular...

Full cohort results confirms efficacy of Luminor drug-coated balloon for BTK...

iVascular reflect on the Luminor drug-coated balloon (DCB) in below-the-knee (BTK) outcomes obtained in the BIBLIOS trial one-year follow-up presented at the Paris Vascular...

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 announce two-year results from DCB catheter registry

Biotronik has announced the two-year results from the BIOLUX P-III BENELUX all-comers registry, presented by principal investigator Frank Vermassen (Ghent University, Gent, Belgium) at...
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...

“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)...

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,...
TOP 10

Interventional News’ top 10 most popular stories in 2022

Interventional News covered a whole range of the specialty's news during 2022, but readers' attention was most piqued by acquisitions (Boston Scientific's of Obsidio...

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

Chocolate Touch drug-coated angioplasty balloon for treatment of peripheral artery disease...

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)...

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

Biotronik 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...
inpact av

IN.PACT AV drug-coated balloon first and only to show sustained and...

Medtronic announced new randomised controlled data demonstrating the sustained and superior performance of IN.PACT AV drug-coated balloon (DCB) compared to percutaneous transluminal angioplasty (PTA)...
biotronik data

Five-year data presented at Charing Cross reinforce safety of Passeo-18 Lux...

New long-term data presented at Charing Cross (CX) demonstrated the safety of BIOTRONIK’s Passeo-18 Lux paclitaxel drug-coated balloon (DCB) for the treatment of peripheral...

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...

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...

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),...

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...
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 four-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...
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...

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...

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,...
amputation

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...
interventional radiology experts

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

A range of interventional radiologists experts including Michael Dake (Tucson, USA), John Kaufman (Portland, USA), Jim Reekers (Amsterdam, The Netherlands) and Gunnar Tepe (Rosenheim,...
Vascular Experts give their thoughts on meta-analysis

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

Vascular and interventional cardiology experts including Kim Hodgson (Springfield, USA), Ramon Varcoe (Sydney, Australia) and Gary Ansel (Columbus, USA) give their thoughts on the...

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...

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

IN.PACT AV access trial meets primary safety and effectiveness endpoints

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...
breakthrough

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

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...

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. So says Peter Gaines (Sheffield, UK) at VLF 2019 while commenting on...

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...

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...

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...
BIBLIOS

BIBLIOS trial has obtained ethics approval and initiated patient enrolment

The BIBLIOS trial has received Ethics Committee (EC) approval, and enrolled its first patient. This announcement comes from Wouter Lansink, who will be treating this...
Lutonix

BD’s Lutonix 018 DCB approved by FDA to treat SFA disease

The FDA has granted approval for BD’s 0.018-inch guidewire-compatible Lutonix 018 drug-coated balloon (DCB) for the treatment of long superficial femoral artery lesions in...

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

 Konstantinos Katsanos (Patras, Greece) tells Interventional News about new data from a meta-analysis that has been published in the Journal of the American Heart...
medtronic

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...

Consider intravascular lithotripsy when treating calcified femoropopliteal arteries

 Treating severely calcified arteries by endovascular means is still a challenge, although atherectomy, stents and lithotripsy are all techniques that are employed.  Lithotripsy (also...
Lutonix

Interim results of the Lutonix drug-coated balloon in a complex patient...

This article is sponsored by BD. In a complex patient population with advanced, symptomatic below-the-knee peripheral artery disease, treatment with the Lutonix drug-coated balloon (BD)...

Lutonix Global AV Registry: DCB use prolongs time to reintervention in...

 Tobias Steinke (Dusseldorf, Germany) reported on the Lutonix Global arteriovenous (AV) Registry at CIRSE 2018 in Lisbon, Portugal. Lutonix Global AV Registry data add to...

Late-breaking trial at CIRSE shows similar outcomes for severely versus non-severely...

Data from a study seeking to determine the impact of severe calcification and 12-month outcomes of femoropopliteal disease treatment using the Stellarex drug-coated balloon...

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 receiving the CE mark for its Kanshas drug-coated balloon catheter used in the treatment of lower extremity peripheral arterial disease. With...

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...

Addressing the data deficit for drug-coated balloon use in dialysis access

The first 24-month data from the LUTONIX AV investigational device exemption trial were presented at the Charing Cross Symposium in April. These interim data...
interim

Latest data on Lutonix and IN.PACT drug-coated balloons in AV access...

There in an increasing physician interest in exploring the role of drug-coated balloons in arteriovenous (AV) access. At the Leipzig Interventional Course (LINC; 30...

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...

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

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

BD announces completion of enrolment in Lutonix 014 DCB below-the-knee trial

Enrolment is complete in the Lutonix below-the-knee trial with BD planning to submit a pre-market approval application to the US Food and Drug Administration...

iVascular initiates TINTIN Luminor trial

iVascular SLU has announced the initiation of the TINTIN trial, evaluating the combined therapy of Luminor drug-coated balloon (DCB) and iVolution self-expandable stent. The TINTIN...

Lutonix registry data confirm durability of drug-coated balloon treatment in superficial...

The 24-month results of the worldwide experience with Lutonix 035 drug-coated balloon (CR Bard/Beckton Dickenson) were published online in August in JACC: Cardiovascular Interventions....

Spectranetics announces FDA approval of Stellarex drug-coated balloon

Spectranetics has announced receipt of US Food and Drug Administration (FDA) premarket approval of the Stellarex drug-coated balloon (DCB), designed to restore and maintain...
Interventional News for specialists

First patient enrolled in IN.PACT arteriovenous access drug-coated balloon study

The US FDA has approved the investigational device exemption (IDE) study to evaluate the safety and efficacy of IN.PACT AV access drug-coated balloon as...

Medtronic gets option to purchase QT Vascular’s non-drug coated Chocolate PTA

QT Vascular has announced that it has entered into an asset purchase option agreement with Medtronic, for the acquisition of the non-drug coated Chocolate...

Positive results for Boston Scientific Ranger paclitaxel-coated PTA balloon catheter

Positive results from the RANGER SFA trial for Boston Scientific’s Ranger paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter have been presented at the 2017...

Lutonix AV results provide tailwind for drug-coated balloons in dysfunctional arteriovenous...

Scott Trerotola presented the first release of eight-month data from the Lutonix AV IDE trial at the Leipzig Interventional Course (LINC; 24–27 January, Leipzig,...