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Late Breaking Data on Pulmonary Vein Isolation with HELIOSTAR™ Balloon Ablation Catheter Presented at AF Symposium 2023
IRVINE, Calif., Feb. 3, 2023 /-- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, announced that positive results from the company-sponsored STELLAR study were presented as a late breaker, titled "Pulmonary Vein Isolation of Paroxysmal Atrial Fibrillation with Multielectrode Radiofrequency Balloon Catheter: Results from the Global, Multicenter, STELLAR Study," at the 28th Annual International AF Symposium.
The STELLAR study investigated the safety and efficacy of pulmonary vein isolation (PVI) using the HELIOSTAR™ Balloon Ablation Catheter in drug refractory symptomatic paroxysmal atrial fibrillation (AFib). This study is the largest clinical study to date with 12-month follow-up data for HELIOSTAR™ Balloon Ablation Catheter.
In the analysis, acute PVI was achieved in 98.8% of subjects, and in 93.0% without additional use of focal catheters. Majority of PVIs were achieved without needing focal touch-up. Primary effectiveness at 12 months was 67.7% and >90% of patients were free from repeat ablation at 12 months. In addition, the rate of clinical success – defined in the study as freedom from 12-month symptomatic atrial arrhythmia recurrence – was 77.7%.1
"With the growing prevalence of AFib, it is important that innovative tools are evaluated in various markets and patient populations to deliver value to patients across regions," said Sandeep Goyal, M.D., FHRS, Director, Electrophysiology Lab, Piedmont Atlanta Hospital, who served as an investigator in the STELLAR studyii. "The results of this study provide further evidence of how RF balloon catheters can be an important tool for electrophysiologists when treating AFib."
The STELLAR Study was an FDA-regulated investigational device exemption study conducted in the US, China and Italy to assess the safety and efficacy of PVI using the HELIOSTAR™ Balloon Ablation Catheter in drug refractory symptomatic paroxysmal AFib.2
The HELIOSTAR™ Balloon Ablation Catheter is the first radiofrequency balloon ablation catheter approved in EMEA for cardiac ablation. The HELIOSTAR™ Balloon Ablation Catheter is fully integrated with the CARTO™ 3 System, enabling an efficient, customizable, and reduced fluoroscopy workflow for PVI.3 HELIOSTAR™ Balloon Ablation Catheter is not approved in the US.
"Biosense Webster is committed to working with the EP community to advance safe, effective and efficient tools to treat cardiac arrhythmias, so that people with AFib can live the lives they want," said Anthony Hong, Vice President, Preclinical and Clinical Research and Medical Affairs, Biosense Webster, Inc. "We are pleased that this analysis from the STELLAR study reinforces the value of the HELIOSTAR™ Balloon Ablation Catheter in treating drug refractory symptomatic paroxysmal atrial fibrillation."
About STELLAR
The STELLAR study is a pivotal, prospective, multicenter, single-arm, clinical evaluation of the Multielectrode RF Balloon catheter. The study will evaluate the safety and effectiveness of the Multielectrode RF Balloon catheter used for ablation in patients with paroxysmal atrial fibrillation (PAF).
About Biosense Webster
Biosense Webster, Inc. is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of Johnson & Johnson MedTech, the specialized medical-technology company is headquartered in Irvine, California, and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care. Learn more at www.biosensewebster.com and connect on LinkedIn and Twitter.
About Johnson & Johnson MedTechi
At Johnson & Johnson MedTechi, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.
© Biosense Webster, Inc. 2023
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i Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson's MedTech segment.
ii Piedmont Healthcare, Inc. entered into a clinical trial agreement with Biosense Webster, Inc. for their participation in the STELLAR Study. Dr. Goyal served as a trial investigator and was not compensated for this authorship contributions.
1 Goyal SK, et al. Pulmonary Vein Isolation of Paroxysmal Atrial Fibrillation with Multielectrode Radiofrequency Balloon Catheter: Results From the Global, Multicenter, STELLAR Study [abstract]. AF Symposium; February 2-4; Boston.
2 ClinicalTrials.gov. Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR). https://clinicaltrials.gov/ct2/show/NCT03683030. Accessed January 11, 2023.
3 Schilling R, et al. Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE. Europace. 2021;23(6):851-860.
