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.

Philips Introduces New 200mm and 150mm Stellarex 0.035-inch Low-dose Drug-coated Balloons
News | Drug-Eluting Balloons | October 15, 2019

October 15, 2019 — Royal Philips introduced two new balloons to its Stellarex 0.035-inch low-dose...

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

October 10, 2019 — An independent analysis of Lutonix 035 drug-coated balloon (DCB) patient-level data showed no...

Virtue Sirolimus-Eluting Balloon Earns FDA Breakthrough Device Designation
News | Drug-Eluting Balloons | September 20, 2019

September 20, 2019 — Orchestra BioMed Inc., in partnership with Terumo Corp. announced the company has secured...

New Report Says Concept Medical Positioned to Disrupt Peripheral Market
News | Peripheral Artery Disease (PAD) | August 27, 2019

August 27, 2019 — Concept Medical was recently granted Breakthrough Therapy designation by the U.S. Food and Drug...

Concept Medical Granted FDA Breakthrough Device Designation for MagicTouch PTA Sirolimus Coated Balloon
News | Peripheral Artery Disease (PAD) | August 14, 2019

August 14, 2019 — Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food...

SeQuent Please ReX Drug-coated Balloon Catheter Receives FDA Breakthrough Device Designation
News | Drug-Eluting Balloons | August 02, 2019

August 2, 2019 — B. Braun Interventional Systems Inc. (BIS) announced the U.S. Food and Drug Administration (FDA)...

Edwards Lifesciences Recalls IntraClude Intra-aortic Occlusion Device
News | Balloon Catheter | July 15, 2019

July 15, 2019 — Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of...

Novel Therapeutic Approach Effective at Reducing Pressure for Heart Failure Patients

Image courtesy of Kapur N.K., Karas R.H., Burkhoff D., et al.

News | Heart Failure | June 17, 2019

June 17, 2019 – Results from a first-in-man proof of concept study found occlusion of the superior vena cava (SVC)...

Orchestra BioMed Partnering With Terumo Corp. for Development, Commercialization of Virtue Sirolimus-eluting Balloon
News | Drug-Eluting Balloons | June 13, 2019

June 13, 2019 — Orchestra BioMed Inc. announced it has formed a global strategic partnership with Terumo Corp. for...

Philips Shares Three-Year Results for Stellarex .035 Drug-Coated Balloon
News | Drug-Eluting Balloons | May 29, 2019

May 29, 2019 — Philips announced the three-year results from the ILLUMENATE Pivotal trial and the ILLUMENATE...

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...

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