Late Breaking Data on Pulmonary Vein Isolation with HELIOSTAR™ Balloon Ablation Catheter Presented at AF Symposium 2023

Rhea-AI Summary

Biosense Webster, part of Johnson & Johnson MedTech, announced positive results from the STELLAR study, presented at the 28th Annual International AF Symposium. This study evaluated the HELIOSTAR™ Balloon Ablation Catheter in patients with drug refractory symptomatic paroxysmal atrial fibrillation (AFib). Key findings include an acute pulmonary vein isolation (PVI) rate of 98.8%, with 67.7% primary effectiveness at 12 months. Furthermore, over 90% of participants remained free from repeat ablation after one year, with a clinical success rate of 77.7%. The HELIOSTAR™ is the first radiofrequency balloon catheter approved in EMEA for cardiac ablation.

Positive

• Acute PVI achieved in 98.8% of subjects.
• Primary effectiveness at 12 months was 67.7%.
• Over 90% of patients free from repeat ablation after 12 months.
• 77.7% clinical success rate defined as freedom from 12-month symptomatic atrial arrhythmia recurrence.
• HELIOSTAR™ is the first radiofrequency balloon ablation catheter approved in EMEA.

Negative

• HELIOSTAR™ Balloon Ablation Catheter is not approved in the US.

Presentation details results from Biosense Webster's global, multicenter STELLAR study 

IRVINE, Calif., Feb. 3, 2023 /PRNewswire/ -- 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.

Cautions Concerning Forward-Looking Statements 
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding HELIOSTAR™ Balloon Ablation Catheter. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc., any of the other Johnson & Johnson MedTech Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 2, 2022, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Biosense Webster, Inc., the Johnson & Johnson MedTech Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 

© 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, Sandeep K., et al. Pulmonary Vein Isolation of Paroxysmal Atrial Fibrillation with Multielectrode Radiofrequency Balloon Catheter: Results From the Global, Multicenter, STELLAR Study [abstract]. In: 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 SHINE primary article Schilling Europace 2021; 23(6):851-860.

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SOURCE Biosense Webster, Inc.

FAQ

What are the key findings from the STELLAR study presented by JNJ?

The STELLAR study showed a 98.8% acute PVI rate and 67.7% primary effectiveness at 12 months.

What is the clinical success rate of the HELIOSTAR™ Balloon Ablation Catheter?

The clinical success rate for the HELIOSTAR™ Balloon Ablation Catheter was 77.7% for freedom from symptomatic atrial arrhythmia recurrence at 12 months.

Is the HELIOSTAR™ Balloon Ablation Catheter approved in the US?

No, the HELIOSTAR™ Balloon Ablation Catheter is not approved in the US.

What is the significance of the STELLAR study for JNJ?

The STELLAR study is significant as it reinforces the efficacy of the HELIOSTAR™ system in treating drug refractory symptomatic paroxysmal AFib.

When were the results of the STELLAR study presented?

The results were presented on February 3, 2023, at the 28th Annual International AF Symposium.