Balloon Catheter

This channel includes news and new technology innovations for angioplasty balloon catheters (PTA). These are used in arteries with atherosclerotic lesions to compress the plaque expand the artery lumen to reopen occluded or heavily stenosed atherosclerotic lesions. Balloons are often used in combination with a stent to prop the treated vessel segment open. In addition to plain old balloon angioplasty (POBA), this section includes news about drug-coated balloon (DCB), valvuloplasty balloons and specialty cutting balloon.

MedAlliance announced enrollment of the first patient in its study of Selution SLR 0.014 drug-eluting balloon (DEB) for the treatment of in-stent restenosis (ISR). This is the first DEB accepted by the FDA for its breakthrough program. The Selution SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).
News | Drug-Eluting Balloons | July 07, 2020
World’s First FDA IDE Coronary Patient Treated With a Drug-eluting Balloon
July 7, 2020 – MedAlliance announced enrollment of the first patient in its study of Selution SLR 0.014 drug-eluting...
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iVascular Launches Essential Pro Coronary Drug-coated Balloon
News | Drug-Eluting Balloons | June 19, 2020
iVascular Launches Essential Pro Coronary Drug-coated Balloon
June 19, 2020 — iVascular SLU announced the global launch of Essential Pro, a novel coronary artery drug-coated balloon...
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MedAlliance announced its second CE mark approval for its Selution SLR 0.014 percutaneous transluminal coronary angioplasty (PTCA) sirolimus drug-eluting balloon (DEB) for the treatment of coronary artery disease. This includes indications for both de-novo lesions as well as in-stent restenosis. The approval applies to a broad range of balloon sizes, from 1.5 x 10 mm, up to 5 x 40 mm.
News | Drug-Eluting Balloons | June 18, 2020
MedAlliance Sirolimus Drug Eluting Balloon Gains Second European CE Mark
June 17, 2020 — MedAlliance announced its second CE mark approval for its Selution SLR 0.014 percutaneous transluminal...
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Transit Scientific announced the U.S. Food and Drug Administration (FDA) cleared the XO Score Percutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal and renal arterial plus synthetic and/or native arteriovenous hemodialysis fistula. This is a new type of scoring balloon technology.
News | Balloon Catheter | June 04, 2020
FDA Clears Scoring Sheath That Fits Over Standard Angioplasty Balloons
June 4, 2020 — Transit Scientific announced the U.S. Food and Drug Administration (FDA) cleared the XO Score...
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MedAlliance has announced the award of its second European CE mark clearance for its Selution SLR 0.014 percutaneous transluminal coronary angioplasty (PTCA) sirolimus drug-eluting balloon (DEB), for the treatment of coronary arterial disease. This includes indications for both de-novo lesions as well as in-stent restenosis.
News | Drug-Eluting Balloons | May 28, 2020
MedAlliance Gains European Clearance for Coronary Drug Eluting Balloon
May 28, 2020 – MedAlliance has announced the award of its second European CE mark clearance for its Selution SLR 0.014...
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Videos | Heart Failure | March 13, 2020
VIDEO: Occluding the SVC as a Reset Button in Heart Failure
Interview with Navin Kapur, M.D., FAHA, FACC, FSCAI, executive director, The CardioVascular Center for Research and...
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NC Trek RX Coronary Dilatation Catheter is part of an FDA Class I recall because it may not defalte.
News | Balloon Catheter | February 24, 2020
Abbott Recalls Two Coronary Balloon Catheters That May Not Deflate
February 24, 2020 — Abbott has voluntarily recalled specific lots of two types of its coronary angioplasty catheters —...
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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
FDA Clears Medtronic Drug-Coated Balloon to Treat Arteriovenous Fistula Lesions
November 21, 2019 — The U.S. Food and Drug Administration (FDA) has cleared the Medtronic In.Pact AV drug-coated...
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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
IN.PACT AV Access 6-Month Data Show Increased Vessel Patency
November 7, 2019 — The IN.PACT Arteriovenous (AV) Access randomized trial evaluating the safety and effectiveness of...
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In.Pact Admiral drug-coated balloon (DCB). #VIVA #VIVA19 #VIVA2019

The In.Pact Admiral drug-coated balloon.

News | Drug-Eluting Balloons | November 07, 2019
Drug-coated Balloon Maintains Good Outcomes in 4-Year IN.PACT Global Study Data
November 7, 2019 — Real-world, four-year study results of the In.Pact Admiral drug-coated balloon (DCB) demonstrate...
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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
No Difference Between Drug-coated Balloons and Plain Balloons After Laser Atherectomy
November 7, 2019 — There was no difference between drug-coated balloons (DCB) vs. plain old balloon angioplasty (POBA)...
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The Selution SLR, MedAlliance’s novel sirolimus-eluting balloon, #VIVA2019 #VIVA #VIVA19
News | Drug-Eluting Balloons | November 06, 2019
Safety and Efficacy Sustained Over Two Years in Selution Drug-eluting Balloon First-in-Human Trial
November 6, 2019 – Positive, two-year data from the first-in-human study of Selution SLR, MedAlliance’s novel sirolimus...
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Eluvia and Ranger PAD devices from Boston Scientific. #VIVA19 #VIVA2019 #VIVA
News | Peripheral Artery Disease (PAD) | November 06, 2019
Positive Data for the Ranger Drug-coated Balloon and Eluvia Vascular Stent
November 6, 2019 – Boston Scientific announced positive data for two of its devices within the peripheral drug-eluting...
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Philips Introduces New 200mm and 150mm Stellarex 0.035-inch Low-dose Drug-coated Balloons
News | Drug-Eluting Balloons | October 15, 2019
Philips Introduces New 200mm and 150mm Stellarex 0.035-inch Low-dose Drug-coated Balloons
October 15, 2019 — Royal Philips introduced two new balloons to its Stellarex 0.035-inch low-dose drug-coated balloon (...
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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
LEVANT Trial Data Shows Safety of Drug-Coated Balloon Shown
October 10, 2019 — An independent analysis of Lutonix 035 drug-coated balloon (DCB) patient-level data showed no...
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