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.

The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLR, MedAlliance’s novel sirolimus-eluting balloon.

News | Drug-Eluting Balloons

First US Patient Enrolled in SELUTION SLR IDE Peripheral Study

August 23, 2022 — The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial ...

August 23, 2022

Results of first vascular robotics study on this scale in China will be published in March 2023

News | Robotic Systems

Robocath’s Joint Venture, Cathbot, Concludes First Clinical Study in China to Evaluate Robotic PCI Safety and Efficacy

July 21, 2022 — Robocath, a company that designs, develops and commercializes innovative robotic platforms for the ...

July 22, 2022

The BIO REACT study was designed to better understand when and where a stent is needed following drug-coated balloon for the treatment of femoropopliteal artery lesions in patients with peripheral artery disease (PAD)

News | Drug-Eluting Balloons

New Data at LINC 2022 Confirm Passeo-18 Lux Drug-Coated Balloon is a Safe and Effective Treatment in Challenging Patient Groups

July 12, 2022 — Biotronik announced the presentation of two studies on the performance of its drug-coated balloon ...

July 12, 2022

Sponsored Content

While the current positive revolution in percutaneous coronary intervention (PCI) practice has been made possible by the wealth of technological advancements, bringing the necessary tools together in a streamlined workflow has remained a challenge for clinicians

Case Study | Baylor Scott and White Heart Hospital

Contemporary PCI: Utilizing State-of-the-Art Technology to Achieve the Best Outcomes

While the current positive revolution in percutaneous coronary intervention (PCI) practice has been made possible by the ...

May 05, 2023

The first patient has been enrolled in the FDA IDE BTK (Below-the-Knee) SELUTION4BTK clinical trial involving SELUTION SLR, MedAlliance’s novel sirolimus-eluting balloon, just one week after receiving IDE approval.

News | Drug-Eluting Balloons

First Patient Enrolled in SELUTION SLR IDE BTK Study

June 8, 2022 — The first patient has been enrolled in the FDA IDE BTK (Below-the-Knee) SELUTION4BTK clinical trial ...

June 08, 2022

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

News | Stents

FDA Class 1 Recall on iCast Stent for Separation Risk That May Cause Harm

June 2, 2022 — According to the U.S. Food and Drug Administration (FDA), Atrium Medical Corporation is recalling the iCa ...

June 02, 2022

Dr. Jeff Healey is seen implanting a subcutaneous defibrillator in a patient at the Electrophysiology Lab. Image credit: Owen Thomas, Hamilton Health Sciences.

Feature | Cardiovascular Business | By Melinda Taschetta-Millane

DAIC's Top 10 Most-read Content for May

Here is what you and your colleagues found to be most interesting in the field of cardiology during the month of May ...

June 01, 2022

Built on the market-leading IN.PACT Admiral DCB technology, the IN.PACT 018 DCB is engineered to cross tight lesions and designed for better deliverability

News | Drug-Eluting Balloons

Medtronic Announces FDA Approval for IN.PACT 018 PTA Balloon Catheter

May 27, 2022 — Medtronic today announced approval from the U.S. Food and Drug Administration (FDA) for the IN.PACT 018 ...

May 27, 2022

The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES).

News | Drug-Eluting Balloons

MedAlliance’s SELUTION SLR Drug-eluting Balloon Receives FDA Investigational Device Exemption Approval

May 27, 2022 — The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a ...

May 27, 2022

Three years ago a study raised concerns that paclitaxel-coated devices may cause increased mortality in peripheral artery disease patients. However, numerous studies now show there is no risk of increased mortality. The most recent study is the SAFE-PAD study presented at SCAI22.

News | Peripheral Artery Disease (PAD)

New Longterm Data of Paclitaxel Devices Continues to Show No Increased Mortality Compared to Non-drug Coated Devices

May 20, 2022 — New long-term data from the Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel ...

May 20, 2022

First multi-center, randomized controlled study provides the largest long-term evidence for the treatment of heavily calcified femoropopliteal lesions

News | Peripheral Artery Disease (PAD)

Disrupt PAD III Trial Demonstrates Safety and Effectiveness of Intravascular Lithotripsy for Peripheral Artery Calcification

May 19, 2022 — One year outcomes from the Disrupt PAD III Trial comparing intravascular lithotripsy (IVL) with a drug ...

May 19, 2022

Boston Scientific announced that Peter M. “Pete” Nicholas, co-founder and former CEO of Boston Scientific from 1979 to 1999 and a corporate visionary in the minimally invasive surgery industry, passed away peacefully on May 14 just a few days before his 81st birthday.

News | Cardiovascular Business

Boston Scientific Co-founder and Former CEO Passes Away

May 16, 2022 — Boston Scientific announced that Peter M. “Pete” Nicholas, co-founder and former CEO of Boston Scientific ...

May 16, 2022

The Neurescue device is an FDA-approved device currently in use for patients with severe bleeding which will now be used in a new study to help increase survival rate for those who experience in-hospital cardiac arrests

News | Sudden Cardiac Arrest

MemorialCare Long Beach Medical Center Only Site in Nation to Offer ARISE-Study – New Experimental Treatment for In-Hospital Cardiac Arrest

May 13, 2022 — The MemorialCare Heart & Vascular Institute at Long Beach Medical Center has been designated the only ...

May 13, 2022

In accordance with its commitment to patient safety, Medtronic recently voluntarily recalled a subset of its IN.PACT Admiral and IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility.

News | Drug-Eluting Balloons

Medtronic Issues Voluntary Recall for Subset of IN.PACT Admiral and IN.PACT AV Drug Coated Balloon

March 31, 2022 — In accordance with its commitment to patient safety, Medtronic recently voluntarily recalled a subset ...

March 31, 2022

News | Balloon Catheter

Cardiovascular Systems, Inc. and OrbusNeich Announce FDA PMA Approval of Scoreflex Scoring Balloon

Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional ...

February 25, 2022

News | Balloon Catheter

CERENOVUS Launches EMBOGUARD Balloon Guide Catheter to Use In the Treatment of Acute Ischemic Stroke

February 15, 2022 – CERENOVUS, an emerging leader in neurovascular care and part of Johnson & Johnson Medical Devices ...

February 15, 2022