Balloon Catheter

This channel includes news and new technology innovations for angioplasty balloon catheters (PTA). These are used in arteries with atherosclerotic lesions to compress the plaque expand the artery lumen to reopen occluded or heavily stenosed atherosclerotic lesions. Balloons are often used in combination with a stent to prop the treated vessel segment open. In addition to plain old balloon angioplasty (POBA), this section includes news about drug-coated balloon (DCB), valvuloplasty balloons and specialty cutting balloon.

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 and...
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) has...
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 balloon...
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 European...
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 Drug...
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 remain...
Swiss-based M.A. MedAlliance SA has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for Selution, its sustained limus release (SLR) drug-eluting balloon (DEB) catheter, for the treatment of coronary disease.
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 and...
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...