Cardiovascular Systems Inc. (CSI) recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the OrbusNeich 1mm Sapphire II Pro coronary balloon.
Balloon Catheter
This channel includes news and new technology innovations for angioplasty balloon catheters (PTA). In addition to POBA, this section includes news about valvuloplasty balloons and specialty cutting balloon.
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Spectranetics is recalling its Bridge Occlusion Balloon Catheter due to the possibility of a blocked guidewire lumen in some device units. If a device with a blocked guidewire lumen were to be...
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C.R. Bard Inc. announced the Lutonix 035 Drug Coated Balloon PTA Catheter (DCB) has been granted premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) for a new indication. With...
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The Spectranetics Corp. announced receipt of U.S. Food and Drug Administration (FDA) pre-market approval (PMA) of the Stellarex drug-coated balloon (DCB). The device is designed to restore and...
Technology | Drug-Eluting Balloons | May 03, 2018
May 3, 2018 — The U.S. Food and Drug Administration (FDA) has expanded the indication for the Medtronic In.Pact ...
Figure 1. Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.
Feature | Cath Lab | April 16, 2018 | Azeem Latib, M.D.
Over the last decade, there have been considerable developments in procedural techniques and technology facilitating...
Technology | Balloon Catheter | March 21, 2018
March 21, 2018 — Cardiovascular Systems Inc. (CSI) recently announced that the U.S. Food and Drug Administration (...
News | Drug-Eluting Balloons | February 07, 2018
February 7, 2018 — Medtronic plc recently added to its body of clinical evidence supporting the In.Pact Admiral...
News | Balloon Catheter | January 24, 2018
January 24, 2018 — Cardiovascular Systems Inc. recently announced two new partnerships broadening the company’s...
News | Peripheral Artery Disease (PAD) | December 29, 2017
December 29, 2017 — iVascular announced the release of the new Oceanus 14 Pro percutaneous transluminal angioplasty...
An illustration of the Sequent Please drug-coated balloon.
Feature | Drug-Eluting Balloons | November 02, 2017
November 2, 2017 — The treatment of in-stent restenosis (ISR) remains challenging in clinical practice. The DARE (...
News | EP Lab | September 27, 2017
September 27, 2017 — Spectranetics is recalling its Bridge Occlusion...
News | Drug-Eluting Balloons | September 18, 2017
September 18, 2017 — Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (...
News | Peripheral Artery Disease (PAD) | September 13, 2017
September 13, 2017 — Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual...
News | Drug-Eluting Balloons | September 13, 2017
September 13, 2017 — Medtronic plc announced that the In.Pact Admiral...
Technology | Drug-Eluting Balloons | August 29, 2017
August 29, 2017 — C.R. Bard Inc. announced the Lutonix 035...
News | Drug-Eluting Balloons | August 15, 2017
August 15, 2017 — Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food...
Technology | Drug-Eluting Balloons | July 26, 2017
July 26, 2017 — The Spectranetics Corp. announced receipt of U.S. Food and Drug Administration (FDA) pre-market...
