IRVINE, Calif. – February 4, 2019 – Johnson & Johnson Medical Devices Companies* announced today that Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmias, has enrolled and treated the first patient in its U.S. Investigational Device Exemption (IDE) study** which evaluates the company’s QDOT MICRO Radiofrequency (RF) Ablation Catheter used for the treatment of symptomatic drug-refractory paroxysmal atrial fibrillation (AF). The first AF patient was treated at NYU Langone Health’s Heart Rhythm Center in New York City, one of up to 30 centers participating in the study that will enroll up to 185 patients throughout the U.S.
“The delivery of 90 watts of RF power in a short, four-second ablation session is a significant advancement in the treatment of paroxysmal atrial fibrillation,” said Dr. Larry A. Chinitz, electrophysiologist and Director of the Heart Rhythm Center at NYU Langone Health, who treated the first patient in the study.+ “We’re eager to see whether this new technology helps to reduce procedure time and improve clinical outcomes.”
Current catheter technologies typically deliver RF ablation at an average power level between 20 and 40 watts and for a duration of 20 to 40 seconds.1 The QDOT MICRO RF Ablation Catheter, which is only available for investigational use in the United States, is the first to deliver 90 watts of RF power in a short, four-second temperature-controlled session. Its temperature control and micro-electrode technology is specifically designed to provide more efficient and consistent lesion creation with advanced diagnostics.
An estimated 33 million people worldwide have been diagnosed with AF and its prevalence is projected to increase significantly as the population ages.2 Approximately 70 percent of patients with AF are between the ages of 65 and 85.3
“The QDOT MICRO RF Ablation Catheter is an example of the innovations we’ve been focused on developing to elevate the standard of care for patients with Cardiac Arrhythmias,” said Uri Yaron, Worldwide President of Biosense Webster, Inc. “We believe this ablation catheter will revolutionize the field of ablation and hope it will make a meaningful difference in outcomes for both physicians and patients, just as the first catheter created by our co-founder, the late Will Webster, did.”
The QDOT MICRO IDE follows the commencement of the STELLAR*** U.S. IDE study in November which will evaluate the safety and effectiveness of the HELIOSTAR Multi-electrode Radiofrequency Balloon Ablation Catheter in treating symptomatic drug refractory recurrent paroxysmal (intermittent) atrial fibrillation.
About Johnson & Johnson Medical Devices Companies
As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopaedics, vision and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. For more information, visit www.jnjmedtech.com.
About Biosense Webster, Inc.
Biosense Webster, Inc., part of Johnson & Johnson Medical Devices Companies, is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. For more information, visit www.biosensewebster.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 the QDOT MICRO Radiofrequency (RF) 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 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 December 31, 2017, 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 Biosense Webster, Inc., 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.
*Comprising the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.
** Evaluation of the QDOT MICRO™ Catheter for pulmonary vein isolation (PVI) in subjects with PAF
*** Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
+ Dr. Larry A. Chinitz performed the first QDOT MICRO procedure in the U.S. and is one of the study clinical investigators.
The device is approved for investigational use only. It is not approved or available for sale.
©Biosense Webster, Inc. 2019
2. European Heart Journal, Volume 37, Issue 38, 7 October 2016, Pages 2893–2962, https://doi.org/10.1093/eurheartj/ehw210
3. Amin A, Houmsse A, Ishola A, Tyler J, Houmsse M. The current approach of atrial fibrillation management. Avicenna J Med. 2016 Jan-Mar; 6(1): 8–16.