Drug-Eluting Balloons

This channel includes news and new technology innovations for drug coated balloons, also referred to as drug-eluting balloons. These are used to treat peripheral and coronary artery lesions and restenosis.

Philips Introduces New 200mm and 150mm Stellarex 0.035-inch Low-dose Drug-coated Balloons
News | Drug-Eluting Balloons | October 15, 2019

October 15, 2019 — Royal Philips introduced two new balloons to its Stellarex 0.035-inch low-dose...

An independent analysis of Lutonix 035 drug-coated balloon (DCB) patient-level data showed no statistically significant mortality increase. This was one of the first major reviews of trial data for patients who were treated with a paclitaxel coated device used in peripheral vessels following a meta analysis study of paclitaxel device trials published in December 2018 that showed a mortality safety signal. This was a major discussion during the FDA townhall meeting at the #TCT2019.
News | Drug-Eluting Balloons | October 10, 2019

October 10, 2019 — An independent analysis of Lutonix 035 drug-coated balloon (DCB) patient-level data showed no...

Virtue Sirolimus-Eluting Balloon Earns FDA Breakthrough Device Designation
News | Drug-Eluting Balloons | September 20, 2019

September 20, 2019 — Orchestra BioMed Inc., in partnership with Terumo Corp. announced the company has secured...

New Report Says Concept Medical Positioned to Disrupt Peripheral Market
News | Peripheral Artery Disease (PAD) | August 27, 2019

August 27, 2019 — Concept Medical was recently granted Breakthrough Therapy designation by the U.S. Food and Drug...

Concept Medical Granted FDA Breakthrough Device Designation for MagicTouch PTA Sirolimus Coated Balloon
News | Peripheral Artery Disease (PAD) | August 14, 2019

August 14, 2019 — Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food...

SeQuent Please ReX Drug-coated Balloon Catheter Receives FDA Breakthrough Device Designation
News | Drug-Eluting Balloons | August 02, 2019

August 2, 2019 — B. Braun Interventional Systems Inc. (BIS) announced the U.S. Food and Drug Administration (FDA)...

Orchestra BioMed Partnering With Terumo Corp. for Development, Commercialization of Virtue Sirolimus-eluting Balloon
News | Drug-Eluting Balloons | June 13, 2019

June 13, 2019 — Orchestra BioMed Inc. announced it has formed a global strategic partnership with Terumo Corp. for...

Philips Shares Three-Year Results for Stellarex .035 Drug-Coated Balloon
News | Drug-Eluting Balloons | May 29, 2019

May 29, 2019 — Philips announced the three-year results from the ILLUMENATE Pivotal trial and the ILLUMENATE...

Concept Medical Inc. Granted Breakthrough Device Designation for MagicTouch Sirolimus Coated Balloon
News | Drug-Eluting Balloons | May 02, 2019

May 2, 2019 — Concept Medical Inc. (CMI) has been granted Breakthrough Device Designation from the U.S. Food and...

Orchestra BioMed Receives FDA Breakthrough Device Designation for Virtue Sirolimus-eluting Balloon
Technology | Drug-Eluting Balloons | April 24, 2019

April 24, 2019 —  Orchestra BioMed Inc. has secured Breakthrough Device designation by the U.S. Food and Drug...

News | Drug-Eluting Balloons | March 06, 2019

March 6, 2019 – Swiss-based M.A. MedAlliance SA has been granted Breakthrough Device Designation from the U.S. Food...

Philips Releases Three-Year Data on Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons | January 28, 2019

January 28, 2019 — Philips announced the latest pooled analysis of patient-level data of over 2,300 patients treated...

FDA Issues Letter About Paclitaxel Coated Balloons and Eluting Stents
News | Peripheral Artery Disease (PAD) | January 17, 2019

January 17, 2019 — The U.S. Food and Drug Administration (FDA) issued a letter...

Virtue Sirolimus-Eluting Balloon Demonstrates Positive Safety and Efficacy at Three Years
News | Drug-Eluting Balloons | September 25, 2018

September 25, 2018 — Orchestra BioMed Inc. announced the three-year clinical results from its Sirolimus Angioplasty...

Overlay Init