Biosense Webster launches HELIOSTAR in Europe, the first radiofrequency balloon ablation catheter, enabling physicians to perform more efficient cardiac ablations

October 14, 2022 — Biosense Webster, Inc.part of Johnson & Johnson MedTech†, today announced the European launch of the HELIOSTAR Balloon Ablation Catheter – the first radiofrequency balloon ablation catheter. The HELIOSTAR Balloon Ablation Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (pacing and recording) of the atria and, when used with a compatible multi-channel RF generator, for cardiac ablation.

Europe has more than 11 million people with atrial fibrillation (A F); 2 by 2030, the number of people with AF is expected to increase by up to 70%.3 In Europe, catheter ablation is a recommended first-line treatment option‡4 and is associated with significant improvement in quality of life and significant reductions in AF burden and AF-related complications.5,6,7

The HELIOSTAR Balloon Ablation Catheter is fully integrated with the CARTO 3 system, a 3D mapping solution. The HELIOSTAR Balloon Ablation Catheter features a conformal balloon that can accommodate varied pulmonary vein anatomy8,§ and provides the ability to isolate the pulmonary vein (PIV) in one go in 12 seconds.1 Use of the HELIOSTAR Balloon Ablation Catheter, along with the LASSOSTAR™ and CARTO 3 System, can reduce fluoroscopy time and exposure,9,10,11,** potentially beneficial to both the patient and the doctor. A shorter procedure time may require less anesthesia and radiation therapy and may result in reduced installation time. These time savings may also allow for more procedures per day, making patient access easier.12,13 The HELIOSTAR™ Balloon Ablation Catheter is not commercially available in the United States.

“The HELIOSTAR catheter is an effective and efficient technology, allowing excellent results in less procedure time, which has many advantages for my patients, for myself and for my staff”, said Prof. . Gian Battista ChierchiaFull Professor of Cardiology, HRMC, Brussels, Belgium, CMO Electrophysiology Frontiers.* “The high success rate of single-shot isolation is especially valuable with regard to procedural efficiency, and at my institution we have been able to perform procedures reproducibly in 15 to 20 minutes.”

The HELIOSTAR Balloon Ablation Catheter features ten gold-plated irrigated electrodes and the amount of power delivered to each electrode can be customized based on anatomical location and known tissue thickness.8,12,16,†† HELIOSTAR™ is the only single-injection balloon multi-electrode with the flexibility to perform both circumferential and segmental ablation, enabling personalized PV ablation.8 The amount of power delivered to each electrode can be independently controlled1 and the catheter can deliver titrated radiofrequency energy for a customizable workflow.14

“The HELIOSTAR Catheter is an exciting addition to my toolset for performing customizable, effective and efficient cardiac ablations. I have performed over 120 cases with this tool at my facility to date, with an average atrial procedure time 35 minutes left,” said Professor Tillman Dahme, Ulm University Medical Center – Department of Medicine II (cardiology, angiology, pulmonology, intensive care medicine), Germany. to offer better and more personalized treatments to my patients.”

In a single-arm, multicenter study, SHINE, the HELIOSTAR Balloon Ablation Catheter was an effective treatment for paroxysmal atrial fibrillation (AF)10 and isolated targeted pulmonary veins (PV) in 98.8% of patients without requiring focal retouching.10 ,‡‡ The mean time to isolation of each pulmonary vein was 9 to 12 seconds.10,§§ In addition, the RADIANCE study demonstrated an 86% freedom from documented atrial arrhythmias at 12 month.15,*** In September 2021, the first post-approval procedures have been successfully performed with the HELIOSTAR Balloon Ablation Catheter at sites across Europe.

“Our goal at Biosense Webster is to use the latest science and technology to help electrophysiologists deliver the best possible outcomes for their patients,” said Michael Bodner, Ph.D., Global President, Biosense Webster Inc. “The launch of the HELIOSTAR Balloon Ablation Catheter in Europe is an exciting milestone as we work with the EP community to advance safe, effective and efficient treatment solutions for patients with atrial fibrillation. »

The HELIOSTAR Balloon Ablation Catheter is CE approved and now available throughout Europe.

For more information: www.biosensewebster.com

Related content:

First Patient Treated in the STELLAR Atrial Fibrillation IDE Study

What’s New in Electrophysiology Technologies

First Human Cases of Atrial Fibrillation in Europe Treated Using the Heliostar Balloon Ablation Catheter

References:

† The Johnson & Johnson MedTech companies include the surgical, orthopedic, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.

* Drs. Chierchia and Dahme are remunerated and present on behalf of Biosense Webster, and must report information in accordance with applicable regulatory requirements.

‡ Recommended first-line therapy for patients with symptomatic episodes of paroxysmal AF or persistent AF without major risk factors for AF recurrence, or as an alternative to AAD Class I or III, based on patient choice , profit and risk.

§ In a multicenter, single-arm SHINE study (n=95), 100% of targeted PVs were electrically isolated and no additional ablation with a focal ablation catheter was required.

** In a single-arm multicenter study, SHINE (n = 95), the time to scopy was 10.9 ± 9.1 minutes in the per-protocol population while in a single-arm multicenter study RADIANCE (n = 40), the scopy time was 17.4 ± 10.1 minutes without using the LASSOSTAR™ diagnostic catheter.

†† Tissue thickness is known by anatomical location or measured by intracardiac echocardiography.

‡‡ This data is based on 7 operators. PV isolation is defined as sustained PV input block during adenosine/isoproterenol challenge.

§§ In a single-arm, multicenter study (SHINE, n=95), pure single-shot isolation was achieved by initial RF application (regardless of ablation duration). Isolation time (mean ± SD, sec) was 9.0 ± 6.46 (LIPV), 12.0 ± 11.58, (LSPV), 9.1 ± 4.95 (RIPV), 8, 9±6.22 (RSPV).

*** 86.4% (32/37) includes DAAs on/off; 75.7% (28/37) off DAAs. Based on n=37/39 pts, observational study.

1 Almorad, A. et al (2021). The optimized clinical workflow for pulmonary vein isolation with the radiofrequency balloon. Journal of Interventional Cardiac Electrophysiology, 10.1007/s10840-021-01094-9. Early online publication.

2 Global Burden of Disease Collaborative Network (2016) Results of the Global Burden of Disease Study 2016 (GBD 2016). Seattle, USA: Institute for Health Metrics and Evaluation (IHME), 2017. Accessed 2018-04-20.

3 Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S (2014) Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 6: 213-220.

4 Hindricks G et al. ESC 2020 guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardiothoracic Surgery (EACTS): The Task Force for the Diagnosis and Management of Atrial Fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498.

5 Walfridsson, Hakan, et al. “Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation: results on health-related quality of life and symptom burden. The MANTRA-PAF trial.” Europace EP. 17.2 (2015): 215-221.

6 Blomström-Lundqvist, Carina, et al. “Effect of catheter ablation versus antiarrhythmic drugs on the quality of life of patients with atrial fibrillation: the CAPTAF randomized clinical trial.” JAMA. 321.11 (2019): 1059-1068.

7 Journal of Nursing: June 2019 – Volume 119 – Number 6 – p 18 doi:10.1097/01.NAJ.0000559795.09114.0b.

8 SHINE Study Clinical Study Report (BWI_2017_01 12M Final Results). December 20, 2019.

9 Calkins et al, 2017HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation, Europace (2018) 20, e1–e160.

10 Schilling, R., Dhillon, G., Tondo, C., et al. Safety, efficacy and quality of life after pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: one-year results from SHINE. Europace (2021) 23, 851-860.

11 RADIANCE multi-electrode radiofrequency balloon catheter for the treatment of symptomatic drug-resistant paroxysmal atrial fibrillation (HELI-169). June 6, 2018.

12 Klein G, Lickfett L, Schreieck J, Deneke T, Wieczorek M et al. (2015) Comparison of “anatomically designed” and “point-to-point” catheter ablations for human atrial fibrillation in terms of timing and costs of the procedure in German hospitals. Europace. 17 (7): 1030-1037.

13 Yildiz M, Yilmaz Ak H, Oksen D, Oral S. Anesthetic management in the electrophysiology laboratory: A multidisciplinary review. Fibrillation J Atr. 2018;10(5):1775. Published February 28, 2018. doi:10.4022/jafib.1775.

14 Reddy, VY et al (2019). Isolation of pulmonary veins with a novel multi-electrode radiofrequency balloon catheter that enables direction-appropriate energy delivery: short-term results from a multicenter First-in-Human (RADIANCE) study. Traffic. Arrhythmia and Electrophysiology, 12(12), e007541.

15 Dhillon, G., Schilling, R. et al. Use of a multi-electrode radiofrequency balloon catheter to achieve pulmonary vein isolation in patients with paroxysmal atrial fibrillation: twelve-month results from the RADIANCE study. Journal of Electrophysiology, April 2020. doi: 10.1111/jce.14476.