The U.S. Food and Drug Administration (FDA) issued a letter Jan. 17, 2019, to healthcare providers regarding a recent publication that suggests a possible increased risk of death at two years and...
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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In 2009, the GuideLiner Catheter revolutionized the concept of guide extension, creating new possibilities in...
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Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for 200mm and 250mm lengths of the In.Pact Admiral Drug-Coated Balloon (DCB) to treat long superficial femoral artery (...
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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.
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 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...
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...
News | Peripheral Artery Disease (PAD) | January 17, 2019
January 17, 2019 — The U.S. Food and Drug Administration (FDA) issued a letter...
News | Ablation Systems | November 30, 2018
November 30, 2018 — Johnson & Johnson Medical Devices Companies announced that Biosense Webster Inc. has...
News | Drug-Eluting Balloons | September 25, 2018
September 25, 2018 — Orchestra BioMed Inc. announced the three-year clinical results from its Sirolimus Angioplasty...
News | Drug-Eluting Balloons | September 24, 2018
September 24, 2018 — New data announced at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference, Sept...
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)...
News | Peripheral Artery Disease (PAD) | August 14, 2018
August 14, 2018 — NuCryo Vascular announced that the company has signed a commercialization agreement with Lokai...
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...
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 (...
