News | Drug-Eluting Balloons | December 06, 2016

Spectranetics Receives CE Mark for Stellarex 0.014-inch Drug-Coated Balloon

Device provides additional treatment option for small vessels, below-the-knee disease and challenging critical limb ischemia

Spectranetics, Stellarex 0.014-inch DCB, CE Mark

December 6, 2016 — The Spectranetics Corp. announced in late November that its Stellarex 0.014-inch drug-coated angioplasty balloon (DCB) has received the CE mark. The device is designed to treat small vessels, below-the-knee disease and challenging critical limb ischemia (CLI) in patients. 

The combination of the currently available Stellarex 0.035-inch and the new 0.014-inch line available in Europe expands Spectranetics’ comprehensive portfolio of next-generation DCBs to treat complex disease states across the lower extremities.

CLI afflicts over 3 million people in the United States and Europe. The critical unmet need of this complex patient population is inhibition of restenosis, which commonly occurs within three to six months of treatment and can lead to high rates of non-wound healing, re-intervention and amputation.

"Now available on a 0.014-inch balloon platform, Stellarex represents a latest-generation DCB backed by compelling evidence in the fem-pop arteries. It holds strong promise to deliver safety and efficacy in the notoriously challenging infrapopliteal district,” said Prof. Dierk Scheinert of Universitätsklinikum in Leipzig, Germany.

For more information: www.spectranetics.com


Related Content

News | Balloon Catheter

April 4, 2024 — The U.S. Food and Drug Administration (FDA) announced that Medos International Sàrl is recalling ...

Home April 04, 2024
Home
News | Balloon Catheter

January 18, 2024 — Summa Therapeutics, LLC announced that the first-in-man injectable angioplasty procedures for ...

Home January 18, 2024
Home
News | Balloon Catheter
Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional ...
Home February 25, 2022
Home
News | Balloon Catheter

February 15, 2022 – CERENOVUS, an emerging leader in neurovascular care and part of Johnson & Johnson Medical Devices ...

Home February 15, 2022
Home
News | Balloon Catheter

May 20, 2021 — Boston Scientific Corporation announced it has initiated the AGENT IDE trial for the Agent Drug-Coated ...

Home May 20, 2021
Home
Feature | Balloon Catheter | By Dave Fornell, Editor

The first devices developed for interventional cardiology were percutaneous transluminal coronary angioplasty (PTCA) ...

Home March 16, 2021
Home
Feature | Balloon Catheter

February 17, 2021 — The U.S. Food and Drug Administration (FDA) has cleared Shockwave Medical's Intravascular ...

Home February 17, 2021
Home
News | Balloon Catheter

June 4, 2020 — Transit Scientific announced the U.S. Food and Drug Administration (FDA) cleared the XO Score ...

Home June 04, 2020
Home
News | Balloon Catheter

February 24, 2020 — Abbott has voluntarily recalled specific lots of two types of its coronary angioplasty catheters — ...

Home February 24, 2020
Home
News | Balloon Catheter

July 15, 2019 — Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of balloon ...

Home July 15, 2019
Home
Subscribe Now