Tag: DCB

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...

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...

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...

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”...

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 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 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 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...

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...