January 28, 2019 — Philips announced the latest pooled analysis of patient-level data of over 2,300 patients treated with Philips’ Stellarex Drug-Coated Balloon (DCB) in above-the-knee (ATK) studies, which the company said reinforces the strong safety profile of Stellarex. The independent, third-party pooled analysis demonstrated low mortality rates through three years after the treatment with no device-related deaths.
Sean Lyden, M.D., chairman of the Department of Vascular Surgery, Cleveland Clinic, presented the data at the 2019 Leipzig Interventional Course (LINC) in Leipzig, Germany.
“The LINC session provided important new patient-level data regarding mortality in patients with peripheral arterial disease receiving paclitaxel devices – stents or DCBs – to restore and maintain blood flow in the superficial femoral and popliteal arteries in their legs,” said William Gray, M.D., FACC, FSCAI, president of the Lankenau Heart Institute and investigator for the Stellarex clinical trials. “The data from the Stellarex clinical trial programs was strong, and represented over 2,300 patients. When the three-year-outcomes were examined, there were no cardiovascular or non-cardiovascular mortality differences between the groups treated with Stellarex and the control arm. This is very reassuring, and this patient-level data will be amalgamated with other paclitaxel device data in order to complete the analysis. These efforts are already underway, as is a publication specifically regarding these Stellarex results.”
The Stellarex DCB is designed to restore and maintain blood flow to arteries in patients with peripheral arterial disease. It is U.S. Food and Drug Administration (FDA)-approved and CE Marked in the U.S. and Europe.
For more information: www.usa.philips.com/healthcare