Tag: Stellarex

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...

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...
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,...

First US patient enrolled in ILLUMENATE BTK study of Stellarex 0.014...

The first US patient has been enrolled in the Stellarex ILLUMENATE below-the-knee (BTK) investigational device exemption (IDE) study, led by principal investigators Bill Gray...

Similar patency outcomes in women and men treated with Stellarex DCB

A study presented at VIVA 2018 (5–8 November, Las Vegas, USA) by Maureen Kohi, associate professor of Clinical Radiology, University of California, San Francisco,...

Two-year ILLUMENATE Global data find 72.4% primary patency with Stellarex DCB

After two years of follow-up, the ILLUMENATE Global study has confirmed the durability of the Stellarex drug-coated balloon (Spectranetics/Philips) with primary patency rates comparable...

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”...

Spectranetics announces FDA approval of Stellarex drug-coated balloon

Spectranetics has announced receipt of US Food and Drug Administration (FDA) pre-market approval of the Stellarex drug-coated balloon (DCB), designed to restore and maintain blood flow...

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...

Combined 12-month analysis of ILLUMENATE EU and US trials presented at...

At LINC 2017 (24–27 January, Leipzig, Germany), Sean Lyden (Cleveland Clinic, Cleveland, USA) presented an update on the 12-month results of the European and...

Positive results for Spectranetics Stellarex demonstrated in ILLUMENATE 12-month data

The final 12-month results of the Stellarex (Spectranetics) drug-coated balloon ILLUMENATE Global Study have found high primary patency and freedom from clinically driven target...

Spectranetics receives CE mark for Stellarex 0.014 drug-coated balloon

Spectranetics’ Stellarex 0.014” drug-coated angioplasty balloon has received the CE mark. The Stellarex 0.014” device is designed to treat small vessels, below-the-knee disease, and challenging...

Stellarex ILLUMENATE 12-month pivotal results are “top-tier” in complex patients

Spectranetics has announced that the final 12-month results of the Stellarex drug-coated balloon ILLUMENATE pivotal trial have been presented at the Transcatheter Cardiovascular Therapeutics...

Spectranetics files FDA pre-market approval application for the Stellarex drug-coated balloon

Spectranetics has submitted its pre-market approval application for the Stellarex drug-coated angioplasty balloon to the US Food and Drug Administration (FDA). Stellarex is designed to restore...

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...