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.

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...

Two devices where safety is being called into question based on clinical data that is being questioned. The Cook Zilver PTX paclitaxel-eluting peripheral stent is among the devices included in a study questioning long-term safety of paclitaxel. The Abiomed Impella RP had higher than expected mortality in its post-approval study, possibly due to poor patient selection and implanting the device too late to aid the patient.

Two device technologies raised concerns in the industry based on recently released clinical data. The Cook Zilver PTX paclitaxel-eluting peripheral stent is among the devices included in a study questioning long-term safety of paclitaxel. The Abiomed Impella RP had higher than expected mortality in its post-approval study, possibly due to poor patient selection and implanting the device too late to aid the patient.

Blog | Cath Lab | February 20, 2019

Clinical study data makes the world go around in cardiology and is the basis of setting guidelines in evidence-based...

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...

First Patient Treated in STELLAR Atrial Fibrillation IDE Study
News | Ablation Systems | November 30, 2018

November 30, 2018 — Johnson & Johnson Medical Devices Companies announced that Biosense Webster Inc. has...

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...

Three-Year Real-World Data Support In.Pact Admiral as Primary PAD Therapy
News | Drug-Eluting Balloons | September 24, 2018

September 24, 2018 — New data announced at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference, Sept...

Gore Molding & Occlusion Balloon for Endovascular Aortic Repair Receives FDA Approval
Technology | Balloon Catheter | August 23, 2018

August 23, 2018 — W. L. Gore & Associates Inc. (Gore) announced U.S. Food and Drug Administration (FDA) 510(k)...

Lokai Medical to Distribute NuCryo Vascular PolarCath Balloon Dilatation System in U.S.
News | Peripheral Artery Disease (PAD) | August 14, 2018

August 14, 2018 — NuCryo Vascular announced that the company has signed a commercialization agreement with Lokai...

FDA Approves 200, 250 Millimeter In.Pact Admiral Drug Coated Balloons
Technology | Drug-Eluting Balloons | June 15, 2018

June 15, 2018 — Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for 200mm and 250mm...

News | Drug-Eluting Balloons | May 29, 2018

May 29, 2018 – M.A. MedAlliance SA has raised $37 million to help develop and commercialize the first sirolimus...

The Medtronic In.Pact Admiral Paclitaxel-coated (DCB) Percutaneous Transluminal Angioplasty Balloon Catheter is now indicated for lesions up to 360 mm in length.
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 ...

Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

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...

Cardiovascular Systems Inc. and OrbusNeich Announce FDA Clearance  of Sapphire II Pro 1mm Coronary Balloon
Technology | Balloon Catheter | March 21, 2018

March 21, 2018 — Cardiovascular Systems Inc. (CSI) recently announced that the U.S. Food and Drug Administration (...

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