Drug-Eluting Balloons

This channel includes news and new technology innovations for drug-coated balloons (DCB), also referred to as drug-eluting balloons. These are used to treat peripheral and coronary artery lesions and restenosis. The balloons carry an antiproliferative drug that is delivered to the wall of arteries when the balloon is expanded. The drug helps prevent neointimal hyperplasia (scar tissue growth) caused by trauma when the vessel segment is treated for atherosclerotic lesions with balloon angioplasty. DCBs can be used to treat hyperplasia in arteriovenous (AV) access fistulae in dialysis patients, where the vessel undergoes repeated trauma from regular punctures. DCBs also are used to treat in-stent restenosis due to scar tissue proliferation inside stents, which can cause a vessel to occlude.

The FDA cleared the IN.PACT AV drug-coated Balloon. Clinical data shows In.Pact AV DCB is Safe, reduces reinterventions and maintains access for end-stage renal disease patients undergoing dialysis
News | November 26, 2019

November 21, 2019 — The U.S. Food and Drug Administration (FDA) has cleared the Medtronic In.Pact AV drug-coated...

The IN.PACT Arteriovenous (AV) Access randomized trial evaluating the safety and effectiveness of the Medtronic IN.PACT AV Access drug-coated balloon (DCB) met both of its endpoints, in data presented at the 2019 Vascular Interventional Advances (VIVA) annual meeting. #VIVA #VIVA19 #VIVA2019

The IN.PACT Arteriovenous (AV) Access randomized trial evaluating the safety and effectiveness of the Medtronic IN.PACT AV Access drug-coated balloon (DCB) met both of its endpoints, in data presented at the 2019 Vascular Interventional Advances (VIVA) annual meeting.

 

News | Drug-Eluting Balloons | November 14, 2019

November 7, 2019 — The IN.PACT Arteriovenous (AV) Access randomized trial evaluating the safety and effectiveness of...

In.Pact Admiral drug-coated balloon (DCB). #VIVA #VIVA19 #VIVA2019

The In.Pact Admiral drug-coated balloon.

News | Drug-Eluting Balloons | November 07, 2019

November 7, 2019 — Real-world, four-year study results of the In.Pact Admiral drug-coated balloon (DCB) demonstrate...

The AngioDynamics/Eximo Medical B-Laser represents a new atherectomy device. #VIVA2019 #VIVA #VIVA19

The AngioDynamics/Eximo Medical B-Laser atherectomy system.

News | Atherectomy Devices | November 07, 2019

November 7, 2019 — There was no difference between drug-coated balloons (DCB) vs. plain old balloon angioplasty (...

The Selution SLR, MedAlliance’s novel sirolimus-eluting balloon, #VIVA2019 #VIVA #VIVA19
News | Drug-Eluting Balloons | November 06, 2019

November 6, 2019 – Positive, two-year data from the first-in-human study of Selution SLR, MedAlliance’s novel...

Eluvia and Ranger PAD devices from Boston Scientific. #VIVA19 #VIVA2019 #VIVA
News | Peripheral Artery Disease (PAD) | November 06, 2019

November 6, 2019 – Boston Scientific announced positive data for two of its devices within the peripheral drug-...

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...

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