News | Ablation Systems | November 30, 2018

First Patient Treated in STELLAR Atrial Fibrillation IDE Study

U.S. trial investigating safety and effectiveness of Heliostar Multi-electrode RF Balloon Ablation Catheter for intermittent AFib

First Patient Treated in STELLAR Atrial Fibrillation IDE Study

November 30, 2018 — Johnson & Johnson Medical Devices Companies announced that Biosense Webster Inc. has enrolled and treated the first patient in its STELLAR U.S. Investigational Device Exemption (IDE) study. The study will evaluate the safety and effectiveness of Heliostar Multi-electrode Radiofrequency (RF) Balloon Ablation Catheter in treating symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation (AF). Up to 640 patients will be enrolled in as many as 40 clinical sites worldwide.

"This new balloon catheter is unique because it conforms to any pulmonary vein anatomy and allows me to control electrodes individually to deliver tailored energy when ablating around pulmonary veins," said cardiac electrophysiologist Rodney Horton, M.D., who treated the first patient in the study with Andrea Natale, M.D., FHRS, FACC, FESC, at the Texas Cardiac Arrhythmia Institute at St. David's Medical Center.

"The Heliostar catheter design has the potential to overcome the limitations of current balloon ablation catheters, result in fewer catheter exchanges and, most importantly, shorter procedure times. Heliostar is an exciting technology and we look forward to seeing the final study results," said Natale, cardiac electrophysiologist and executive medical director, Texas Cardiac Arrhythmia Institute at St. David's Medical Center+.

The Heliostar RF Balloon Ablation Catheter has 10 electrodes, which allows electrophysiologists to deliver different levels of energy depending on the tissue during lesion creation. In addition, the balloon design makes it possible to achieve pulmonary vein isolation with a single application of RF energy. The device is compatible with the Biosense Webster CARTO 3 Mapping System, an advanced imaging technology that enables creation of real-time 3-D maps of a patient's cardiac structures. The use of the CARTO 3 System during an ablation procedure can reduce exposure to radiation from fluoroscopy.

It is estimated that 33 million people worldwide are living with AF, or an irregular heartbeat, which can lead to blood clots, stroke, heart failure and other heart-related complications.1

For more information: www.biosensewebster.com

 

Reference

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4151302/


Related Content

News | Ablation Systems

January 31, 2023 —Imricor, a global leader in real-time interventional cardiac magnetic resonance (iCMR) ablation ...

Home January 31, 2023
Home
News | Ablation Systems

December 21, 2022 — Stereotaxis, a global leader in robotic technologies for the treatment of cardiac arrhythmias ...

Home December 21, 2022
Home
News | Ablation Systems

October 24, 2022 — Acutus Medical, Inc, an arrhythmia management company focused on improving the way cardiac ...

Home October 24, 2022
Home
News | Ablation Systems

May 13, 2022 — Acutus Medical, an arrhythmia management company focused on improving the way cardiac arrhythmias are ...

Home May 13, 2022
Home
News | Ablation Systems

May 4, 2022 – Stereotaxis, the global leader in innovative robotic technologies for the treatment of cardiac arrhythmias ...

Home May 04, 2022
Home
News | Ablation Systems

April 5, 2021 — Acutus Medical today announced initial U.S. enrollments in the company’s AcQForce Flutter ...

Home April 05, 2021
Home
News | Ablation Systems

June 16, 2020 – The Montreal Heart Institute (MHI) and Thermedical, a developer of thermal-ablation systems to treat ...

Home June 16, 2020
Home
News | Ablation Systems

May 8, 2020 – Results from a first-in-human early feasibility study (EFS) using a saline enhanced radiofrequency (SERF) ...

Home May 08, 2020
Home
Feature | Ablation Systems

May 8, 2020 — A new clinical trial effectively uses pulsed field (PF) energy to treat patients with persistent or ...

Home May 08, 2020
Home
Videos | Ablation Systems

Clifford Robinson, M.D., associate professor of radiation oncology, chief of the SBRT service, director of clinical ...

Home September 26, 2019
Home
Subscribe Now