HELIOSTAR™ Balloon Ablation Catheter is the first-ever radiofrequency balloon ablation catheter and supports more efficient cardiac arrhythmia ablation procedures
IRVINE, CA – September 28, 2021 – Biosense Webster, Inc., part of the Johnson & Johnson Medical Devices Companies* today announced post-approval procedures were successfully performed with the first-ever radiofrequency balloon ablation catheter at sites across Europe with Biosense Webster’s HELIOSTAR™ Balloon Ablation Catheter. In Europe, the HELIOSTAR Balloon Catheter is indicated for use in catheter-based cardiac electrophysiological mapping of the atria and for cardiac ablation.
Europe is home to more than 11 million people living with atrial fibrillation (AF), and estimates state that by 2030 the number of people with AF is projected to increase by up to 70%.1,2 In Europe, catheter ablation is a recommended first-line treatment option**13 and is associated with a significant improvement in quality of life and significant reductions in AF burden and AF-related complications.3,4,5
The HELIOSTAR Balloon Ablation Catheter, with the LASSOSTAR™ Catheter and CARTO® 3 System, allows physicians to provide more efficient ablation procedures, with lower procedure times and reduced fluoroscopy time and exposure***, potentially benefitting both the patient and physician.6,7,8 Shorter procedure time may require less anesthesia and radiation and may result in less nursing and facility time. These time savings may also enable more procedures per day facilitating patient access.9,10
The novel HELIOSTAR Balloon Ablation Catheter features ten gold-plated, irrigated electrodes that can be tailored based on anatomical location and known tissue thickness**** enabling personalized ablation procedures for unique patient anatomies and arrhythmias.8,11,12 The amount of power delivered to each electrode can be controlled independently to provide electrophysiologists with greater customization, control and the ability to achieve pulmonary vein (PV) isolation in approximately ten seconds.*****9
“Pulmonary vein isolation is a technically complex and time-consuming procedure so it’s important that advancements in balloon ablation systems help electrophysiologists quickly and easily isolate the pulmonary veins, while maintaining safety,” said Ahmed Abdelaal, Senior R&D Director and HELIOSTAR Project Leader at Biosense Webster. “The HELIOSTAR Balloon Ablation Catheter was developed with electrophysiologists in mind giving them the ability to perform personalized ablation procedures to better meet patient’s needs.”
In a multicenter single-arm study, SHINE, the HELIOSTAR™ Balloon Ablation Catheter was an effective treatment for paroxysmal atrial fibrillation (AF) and electrophysiologists isolated targeted pulmonary veins (PV) in 98.8% of patients without the need for focal touch-up.******7 On average, time to isolation of the pulmonary vein was approximately ten seconds, total procedure time was less than 90 minutes and dwell time was less than 40 minutes.*****,*******7
“HELIOSTAR™ Balloon Ablation Catheter reaffirms our commitment to partnering with physicians to advance the practice of electrophysiology and to help change the lives of patients suffering from atrial fibrillation,” said Uri Yaron, Worldwide President of Biosense Webster, Inc. “With CE mark approval and the first commercial procedures completed, we have made significant progress in providing electrophysiologists with another novel option for the safe and efficient treatment of this burdensome disease.”
In Europe, full commercial availability is expected in 2022. In the United States, HELIOSTAR is an investigational device and is not approved by the U.S. Food & Drug Administration.
About Biosense Webster
Biosense Webster is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of the Johnson & Johnson Family of Companies, the specialized medical-technology company is headquartered in Irvine, Calif., 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 Medical Devices Companies
At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere. For more information, visit www.jnjmedtech.com.
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, any of the other Johnson & Johnson Medical Devices 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; [manufacturing difficulties and delays; 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 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent 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 the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
* The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment
** Recommended first-line treatment for patients with symptomatic Paroxysmal AF episodes or persistent AF without major risk factors for AF recurrence, of as an alternative to AAD class I or III, considering patient choice, benefit, and risk.
*** In a multicenter single-arm study, SHINE (n=95), fluoroscopy time was 10.9 ± 9.1 minutes in per-protocol population while in a multicenter single-arm study RADIANCE (n=40), fluoroscopy time was 17.4 ± 10.1 minutes without using LASSOSTAR™ Diagnostic Catheter.
**** Tissue thickness is known per anatomical location or measured via intracardiac echocardiography.
***** In a multicenter single-arm study (SHINE, n=95), pure single shot isolation was achieved by one initial RF application (regardless of the duration of ablation). Time to isolation (mean ± SD, sec) was 9.0 ± 6.46 (LIPV), 12.0 ± 11.58, (LSPV), 9.1 ± 4.95 (RIPV), 8.9 ± 6.22 (RSPV).
****** This data is based on 7 operators. PV isolation is defined as sustained PV entrance block on adenosine/isoproterenol challenge. PV isolation is defined as sustained PV entrance block on adenosine/isoproterenol.
******* SHINE study (n = 95, roll-ins = 8 patients). Per SHINE protocol, a roll-in phase of up to 3 patients per physician was implemented. Total procedure time: 87.6 ± 22.25 min. and dwell time: 40.3 ± 16.69 min.
- Global Burden of Disease Collaborative Network (2016) Global Burden of Disease Study 2016 (GBD 2016) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2017. Accessed 2018-04-20.
- Zoni-Berisso M, Lercari F, Carazza T, Domenicucci S (2014) Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol. 6: 213-220.
- Walfridsson, Håkan, 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." EP Europace. 17.2 (2015): 215-221.
- Blomström-Lundqvist, Carina, et al. "Effect of catheter ablation vs antiarrhythmic medication on quality of life in patients with atrial fibrillation: the CAPTAF randomized clinical trial." JAMA. 321.11 (2019): 1059-1068.
- Journal of Nursing: June 2019 - Volume 119 - Issue 6 - p 18 doi:10.1097/01.NAJ.0000559795.09114.0b.
- Calkins et al, 2017HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation, Europace (2018) 20, e1–e160.
- Schilling, R., Dhillon, G., Tondo, C., et al. Safety, Effectiveness, and Quality of Life Following Pulmonary Vein Isolation with a Multi-Electrode Radiofrequency Balloon Catheter in Paroxysmal Atrial Fibrillation: One Year Outcomes from SHINE. Europace (2021) 23, 851-860.
- Dhillon G, Honarbakhsh S, di Monaco Antonio et al. Use of a multi-electrode radiofrequency balloon catheter to achieve pulmonary vein isolation in patients with paroxysmal atrial fibrillation: 12-Month outcomes of the RADIANCE study. J Cardiovasc Electrophysiol. 2020 Jun;31(6):1259-1269.
- Klein G, Lickfett L, Schreieck J, Deneke T, Wieczorek M et al. (2015) Comparison of ‘anatomically designed’ and ‘point-by-point’ catheter ablations for human atrial fibrillation in terms of procedure timing and costs in German hospitals. Europace. 17 (7): 1030-1037.
- Yildiz M, Yilmaz Ak H, Oksen D, Oral S. Anesthetic Management In Electrophysiology Laboratory: A Multidisciplinary Review. J Atr Fibrillation. 2018;10(5):1775. Published 2018 Feb 28. doi:10.4022/jafib.1775.
- HELIOSTAR™ Balloon Ablation Catheter Clinical Evaluation Report 100503977 Rev 3; CO:100610371.
- Grimaldi et al., Impact of Workflow Modifications in Atrial Fibrillation Ablation for Reducing the Incidence of Silent Cerebral Lesions with a New Multi-Electrode Radiofrequency Balloon Catheter, ESC 2019.
- Hindricks G et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic 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.
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Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® 3 System User Guide regarding recommendations for fluoroscopy use.
Pellegrino, P.L., Brunetti, N.D., Gravina, D., Sacchetta, D., De Sanctis, V., Panigada, S., Di Biase, L., Di Biase, M., and Mantica, M. (2013). Nonfluoroscopic mapping reduces radiation exposure in ablation of atrial fibrillation. Journal of cardiovascular medicine 14, 528-533.
Earley, M.J., Showkathali, R., Alzetani, M., Kistler, P.M., Gupta, D., Abrams, D.J., Horrocks, J.A., Harris, S.J., Sporton, S.C., and Schilling, R.J. (2006). Radiofrequency ablation of arrhythmias guided by non-fluoroscopic catheter location: a prospective randomized trial. Eur Heart J 27, 1223-1229
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