News | Drug-Eluting Balloons | January 28, 2019

Philips Releases Three-Year Data on Stellarex Drug-Coated Balloon

Independent third-party pooled analysis demonstrates low mortality rates with no device-related deaths

Philips Releases Three-Year Data on Stellarex Drug-Coated Balloon

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.

Read "Safety of Paclitaxel-eluting Stents and Balloons Called Into Question"

For more information:

Related Content

Edwards Lifesciences Recalls IntraClude Intra-aortic Occlusion Device
News | Balloon Catheter | July 15, 2019
Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of balloon rupture during...
Gore Molding & Occlusion Balloon for Endovascular Aortic Repair Receives FDA Approval
Technology | Balloon Catheter | August 23, 2018
W. L. Gore & Associates Inc. (Gore) announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Gore...
Cardiovascular Systems Inc. and OrbusNeich Announce FDA Clearance  of Sapphire II Pro 1mm Coronary Balloon
Technology | Balloon Catheter | March 21, 2018
Cardiovascular Systems Inc. (CSI) recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k...
Cardiovascular Systems Expands Product Portfolio for Peripheral and Coronary Interventions
News | Balloon Catheter | January 24, 2018
Cardiovascular Systems Inc. recently announced two new partnerships broadening the company’s product portfolio. CSI is...
Abbott recalls its NC Balloon catheters
News | Balloon Catheter | May 22, 2017
May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports
Videos | Balloon Catheter | November 16, 2016
A discussion with Todd Brinton, M.D., about the newly FDA-cleared Shockwave Medical Lithoplasty System, at the Transc
NuCryo Vascular, Next Generation Cryoplasty Inflation Device, PolarCath Balloon Dilatation System

PolarCath Balloon Dilatation System image courtesy of NuCryo Vascular

Technology | Balloon Catheter | March 28, 2016
NuCryo Vascular LLC announced the launch of the Next Generation Cryoplasty Inflation device. The device received U.S....
NuCryo Vascular, FDA clearance, next-gen, PolarCath System, cryoplasty inflation device
Technology | Balloon Catheter | January 12, 2016
NuCryo Vascular LLC announced that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance on the...
Videos | Balloon Catheter | October 30, 2015
Todd Brinton, M.D., clinical associate professor and consulting associate professor of bioengineering at Stanford Uni
Overlay Init