Tag: lutonix

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...
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...

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 BTK randomised trial meets safety and efficacy endpoints at six...

Six-month outcomes of a multicentre randomised controlled trial using the Lutonix 014 drug-coated balloon (BD; DCB) has demonstrated the DCB is safe to use...

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...

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...

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...

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...

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 trial at the Leipzig Interventional Course (LINC; 24–27 January, Leipzig, Germany)...

Global cohorts report drug-coated balloon success above the knee and “promising”...

Three global registries reported fresh data at the 2017 Leipzig Interventional Course (LINC; 24–27 January, Leipzig, Germany), all of which showed encouraging outcomes for...

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...

Lutonix Global Real-World Registry 24-month outcomes presented at VIVA 2016

Bard has announced the presentation of the final 24-month results from the Lutonix Global Real-World Registry at the Vascular Intervention Advances (VIVA) 2016 meeting...

FDA approves six-month primary endpoint for the Lutonix below-the-knee drug-coated balloon

The US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint to a six-month...

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...