Tag: Stellarex

Philips receives FDA approval for low-dose drug-coated balloons

Philips has received US Food and Drug Administration (FDA) approval for two Stellarex 0.035” low-dose (200mm and 150mm) drug-coated balloons for the treatment of...

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 its 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...
stellarex

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,...

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...

Philips completes acquisition of Spectranetics

Philips has announced that it has completed the acquisition of The Spectranetics Corporation, a US-based global leader in vascular intervention and lead management solutions....

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...

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 gets CE mark for Stellarex 0.014” drug-coated balloon

Spectranetics has announced that its Stellarex 0.014” drug-coated angioplasty balloon has received the CE mark. The device is designed to treat small vessels, below-the...