Tag: DCB

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...

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,...