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.

Concept Medical Inc. Granted Breakthrough Device Designation for MagicTouch Sirolimus Coated Balloon
News | Drug-Eluting Balloons | May 02, 2019

May 2, 2019 — Concept Medical Inc. (CMI) has been granted Breakthrough Device Designation from the U.S. Food and...

Edwards Recalls Miller and Fogarty Balloon Dilation Atrioseptostomy Catheters
News | Congenital Heart | April 29, 2019

April 29, 2019 — Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation...

Orchestra BioMed Receives FDA Breakthrough Device Designation for Virtue Sirolimus-eluting Balloon
Technology | Drug-Eluting Balloons | April 24, 2019

April 24, 2019 —  Orchestra BioMed Inc. has secured Breakthrough Device designation by the U.S. Food and Drug...

Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators

Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions...

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...

Sponsored Content | Videos | Cath Lab | November 07, 2018

In 2009, the GuideLiner Catheter...

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...

Overlay Init