Tag: paclitaxel

reaction to meta analysis

Reaction to the Katsanos et al meta-analysis

Internal BIBA MedTech data show that perceptions on paclitaxel devices have shifted considerably in the twelve months that have elapsed since Konstantinos Katsanos (Patras,...

CIRSE 2019: Hear the latest from clinical trials comparing paclitaxel technologies...

NOTE: ONLY intended for healthcare professionals outside of the USA and France. Zoom in on a tête-à-tete between Marianne Brodmann (Graz, Austria) and Giovanni Torsello...
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...

BASIL-3 resumes randomisation

The BASIL-3 study, which was halted in response to findings reported in the Journal of the American Heart Association (JAHA) that paclitaxel-coated and –eluting...
Medtronic

Medtronic statement regarding updated FDA letter to healthcare providers on paclitaxel...

Medtronic has issued the following statement regarding the US Food and Drug Administration’s (FDA) updated letter to healthcare providers for paclitaxel-devices in patients with...
FDA

FDA: Paclitaxel device clinical trials “may continue”; Agency is working to...

Clinical studies of paclitaxel-coated balloons and paclitaxel-eluting stents “may continue and should collected long-term safety (including mortality) and effectiveness data”, says the US Food...

FDA notifies BD that Lutonix paclitaxel balloon PMA application for below...

The US Food and Drug Administration (FDA) have denied BD premarket approval (PMA) for the company’s Lutonix drug-coated balloon (DCB) in the treatment of...

FDA notifies BD that Lutonix paclitaxel balloon PMA request for below...

The US Food and Drug Administration (FDA) have denied BD premarket approval (PMA) for the company’s Lutonix drug-coated balloon (DCB) in the treatment of...

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...
paclitaxel

C3 2019: Highlights from the 15th annual meeting

Rajesh Dave (Camp Hill, USA) talks to iWounds News about his highlights from the 15th annual C3 conference, which included a special session on...

Medtronic and BD respond to FDA circulatory system devices panel

Both Medtronic and BD have released statements in response to the FDA circulatory system devices panel held last week (19–20 June, Washington, DC, USA)....
Kim Hodgson

SVS VQI data being “fortified” to shed light on long-term paclitaxel...

 Kim Hodgson (Springfield, USA), president of the Society for Vascular Surgery (SVS) for 2019–20 spoke to Vascular News at the organisation’s Vascular Annual Meeting...

US FDA panel reviews paclitaxel device data: No recommendations issued, as...

The US Food and Drug Administration (FDA) convened this week for a General Issues Panel Meeting on the late mortality safety signal associated with...

Society for Vascular Surgery’s VQI adds new analysis to paclitaxel device...

The Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI), with its large multicentre registries has produced several datasets for analysis of vascular patient...
paclitaxel

Holden et al find no causal link between paclitaxel dose and...

The methodology underpinning the conclusion by Konstantinos Katsanos (Patras, Greece) et al that there is a positive dose-response relationship between paclitaxel and mortality is...

Highlights from the CX 2019 session, Paclitaxel: The last word

 Watch the video roundup from the CX 2019 Highlight Session, Paclitaxel: The last word. Filmed onsite at the Charing Cross Symposium (15–18 April 2019, London,...
MDA

MHRA issues medical device alert for paclitaxel use in the UK

Do not use paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs) in the routine treatment of patients with intermittent claudication until further notice, a...
MHRA

MHRA limits routine clinical use of paclitaxel devices following expert advisory...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) acted to limit the future use of paclitaxel-eluting stents and paclitaxel-coated balloons in routine clinical...

SWEDEPAD trials set to resume enrolment

Investigators of SWEDEPAD have announced the conclusion of their safety committee analysis, which recommends the halted trials resume enrolment. This decision to consider resuming enrolment...

The impact of paclitaxel concerns on vascular access

At the 2019 Charing Cross Symposium (CX; 15–18 April, London, UK), there was a section of the programme on drug-coated balloon trial updates which...
patient-level

Cook Medical releases patient-level data from Zilver PTX paclitaxel-eluting stent study

Cook Medical has released de-identifiable patient-level data from a clinical trial of its Zilver PTX peripheral paclitaxel-eluting stent. The move comes a month after the...

Hear the latest thoughts on paclitaxel from global experts: Their current...

 Following the latest information presented at the Charing Cross (CX) International Symposium related to the meta-analysis of paclitaxel-coated devices (Katsanos et al), hear from a...

CX 2019: Evidence supports safety of paclitaxel-coated devices

 At the Charing Cross International Symposium, Gary Ansel (Columbus, Ohio) moderates a global panel that includes Thomas Albrecht (Berlin, Germany), Peter Schneider (San Francisco,...

CX 2019: Cook leads the way to data transparency with release...

 There were calls for greater transparency and sharing of the available randomised controlled trial data of paclitaxel-coated devices at the CX 2019 Highlight Session, Paclitaxel:...
paclitaxel

While CX audience deems paclitaxel not dangerous, vascular pathologist says establishing...

Delegates voted overwhelmingly against the notion that there was a demonstrable danger in any organ of the body attributed to circulating paclitaxel. These polling...

Surmodics provides update regarding TRANSCEND clinical trial

Surmodics has announced the company has now resumed patient enrolment into its TRANSCEND clinical trial, and is nearly 75% of the way to its...
CIRSE

CIRSE updates position on paclitaxel use in peripheral arteries

The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) has released a statement on the use of paclitaxel-coated balloons and stents in the treatment...

Update from the SVS paclitaxel safety task force

In response to the updated letter to healthcare providers from the US Food and Drug Administration (FDA), the Society for Vascular Surgery (SVS) released...

UK MHRA forms Expert Advisory Group to review paclitaxel devices while...

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the Food and Drug Administration (FDA) in the USA have both recently...

Pooled analysis of four RCTs finds no increased mortality with paclitaxel-coated...

A new paper looking specifically at mortality has found no difference in deaths between paclitaxel-coated balloons and uncoated balloons when used in the femoropopliteal...

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...
paclitaxel

Paclitaxel-releasing devices: An unfolding story

Paclitaxel Timeline: Meta-analysis finds a higher risk of death in the long term when paclitaxel-coated devices are used in the leg Without additional long-term...

VLF 2019: White paper and individual patient data analysis are planned...

 Krishna Rocha-Singh (Springfield, USA) tells Vascular News that plans after VLF 2019 include publishing a white paper and expeditiously pooling individual patient-level data from...

Revised safety analysis of Medtronic’s IN.PACT Admiral DCB published in JACC

Medtronic has issued the following statement regarding revised clinical study data: On 15 February, 2019, Medtronic issued a statement regarding a programming error in the...

Vascular Leaders Forum discussions seek consensus on paclitaxel

The Vascular Leaders Forum (VLF, 1–2 March, Washington DC, USA), hosted by the non-profit organisation VIVA Physicians, is a special consortium which was called...

“No evidence of increased long-term mortality” with paclitaxel-eluting stent in new...

“Drug-eluting stents (DES) are important additions to the armamentarium of devices used for peripheral artery revascularization, associated with decreased rates of restenosis and target...
Medtronic

Medtronic revises IN.PACT post-market study data due to programming error, but...

Medtronic has issued the following statement regarding revised clinical study data: Recently, Medtronic became aware of a programming error in the clinical data reporting isolated...

New JAMA analysis with short follow-up finds “an association of survival”...

A recent US-wide, multicentre analysis has found no evidence of increased all-cause mortality associated with the use of paclitaxel-coated devices compared with non-drug-coated devices...

Passeo-18 Lux DCB remains safe and effective at two years with...

Two-year data on the Passeo-18 Lux drug-coated balloon (DCB; Biotronik) continue to validate its safety and effectiveness in intra-inguinal arteries. Gunnar Tepe from the...

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

ISET Paclitaxel Town Hall: Vast majority of attendees will not change...

The discussion around the use of paclitaxel-coated and eluting devices continues at the 31st International Symposium on Endovascular Therapy (ISET; 27-30 January 2019, Hollywood, USA). Organisers...
SCAI

Society for Cardiovascular Angiography and Interventions supports continued use of paclitaxel...

Experts from the Society for Cardiovascular Angiography and Interventions (SCAI) have reviewed the recent meta-analysis by Katsanos and colleagues and have concluded that the...
stellarex

Latest data from Philips reinforces the safety profile of Stellarex low-dose...

A new pooled analysis of patient-level data from Philips demonstrates the “strong safety profile” of the company's Stellarex drug-coated balloon (DCB) in above-the-knee studies,...

Patient-level survival analysis demonstrates no link between paclitaxel dose and mortality...

New data on the IN.PACT Admiral drug-coated balloon (DCB; Medtronic) in patients with peripheral arterial disease (PAD) in the superficial femoral (SFA) and popliteal...

Data presented at LINC confirm the safety and effectiveness of Zilver...

Findings presented at the Leipzig Interventional Course (LINC; 22–25 January 2019, Leipzig, Germany) contradict the results of a meta-analysis published in the Journal of...

IN.PACT independent patient-level meta-analysis shows no correlation between paclitaxel exposure and...

 A renowned panel, moderated by Dierk Scheinert (Leipzig, Germany), comprising Peter Schneider (Honolulu, USA), John Laird (St Helena, USA) and Thomas Zeller (Bad Krozingen,...

US FDA evaluating paclitaxel data, recommend patient surveillance

The impact of the 2018 meta-analysis of randomised paclitaxel-device trials, published in the Journal of the American Heart Association by Konstantinos Katsanos et al,...
medtronic

Medtronic and Boston Scientific stand by paclitaxel devices despite Katsanos’ critical...

Speaking to investors at the JP Morgan healthcare conference in San Francisco, executives from Medtronic and Boston Scientific said their data do not show...

SWEDEPAD 1 and SWEDEPAD 2 trials halt inclusion after Katsanos et...

Vascular News has learned that inclusion into the SWEDEPAD studies, that are examining benefits of drug-eluting technology for peripheral arterial disease patients, has been...
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...

Paclitaxel-eluting stent loses BATTLE against bare metal stent

The BATTLE trial comparing a drug-eluting stent (Zilver PTX, Cook Medical) vs. a bare metal stent (Misago, Terumo) for the treatment of intermediate femoropopliteal...

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...

“Promising” 12-month outcomes achieved with the Chocolate Touch drug-coated balloon

The final results of the ENDURE study, investigating the efficacy of the Chocolate Touch drug-coated balloon (QT Vascular), show “promising evidence of the drug...