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Additional real-world outcomes further demonstrate safety, efficacy and procedural reproducibility of the FARAPULSE Pulsed Field Ablation System*

Results from global trial of the POLARx Cryoablation System* meet safety and effectiveness endpoints

MARLBOROUGH, Mass., May 20, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced data supporting use of the company's key electrophysiology and cardiac rhythm management therapies, and the WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device. All data were presented at Heart Rhythm 2023, the annual meeting of the Heart Rhythm Society, held in New Orleans from May 19-21.

Real-world outcomes from the EU-PORIA registry of the FARAPULSE Pulsed Field Ablation (PFA) SystemReal-world outcomes from the multi-center EU-PORIA registry were highlighted in a late-breaking data presentation, further demonstrating the safety, efficacy and learning curve characteristics of the FARAPULSE PFA System. The registry data included favorable single procedure success rates, along with efficient procedure times in a broad patient population. More than 1,200 patients with paroxysmal or persistent atrial fibrillation (AF)** were enrolled and treated at seven high-volume European centers.

Key findings from the registry:

Primary results of the FROZEN-AF IDE trial with the POLARx Cryoablation SystemResults from the global, prospective, non-randomized, single-arm FROZEN-AF IDE study of the POLARx Cryoablation System met the safety and effectiveness endpoints of the trial. The study, which examined use of the device for the treatment of patients with paroxysmal, or intermittent atrial fibrillation (AF), included an extension arm for the POLARx FIT Cryoballoon Catheter, a single device capable of enabling 28 and 31mm sizes. The extension arm sub-study also achieved its safety and effectiveness endpoints and included 50 patients who were treated with at least one application of the 31mm cryoballoon and will be followed for 12 months. At the time of data release, patients had undergone six out of a total of 12 months of follow up.

Key findings from the trial:

Effects of the EMBLEM MRI Subcutaneous Implantable Defibrillator (S-ICD) on tricuspid regurgitationData from a secondary analysis of the investigator-sponsored, randomized ATLAS trial compared among nearly 450 patients the severity of tricuspid regurgitation at six months following the implantation of a transvenous implantable cardioverter-defibrillator (TV-ICD) versus the EMBLEM MRI S-ICD. Tricuspid regurgitation is a disease that occurs when the tricuspid valve does not close properly and is a risk factor for heart failure.

Key findings from the analysis:

Hybrid strategy for secondary prevention of sudden cardiac death using ventricular tachycardia (VT) ablation and the EMBLEM MRI S-ICDThe prospective, investigator-sponsored VTabl-SICD trial explored among 32 patients the safety and efficacy of a novel hybrid management strategy combining VT ablation with S-ICD implantation in patients who have scar-related VT. Findings from the study suggested that the combination strategy was superior to conventional TV-ICD implantation for the secondary prevention of sudden cardiac death by significantly reducing the need to deliver ICD therapy and avoiding untreated, symptomatic arrhythmias.

Notable developments for the WATCHMAN FLX LAAC DeviceData presented from two new sub-analyses of the SURPASS study out of the National Cardiovascular Data Registry (NCDR) LAAO Registry provided insights into real-world treatment strategies with the WATCHMAN FLX LAAC Device. The first analysis assessed outcomes with different post-procedural antithrombotic therapies and demonstrated that patients treated with direct oral anticoagulants (DOAC) alone had the lowest risk of major adverse events in comparison to other drug regimens following the implant. The second analysis demonstrated that concomitant catheter ablation and LAAC with the WATCHMAN FLX device was safe and had similar outcomes when compared to device implantation alone.

In addition, the latest preclinical data for the investigational WATCHMAN FLX Pro LAAC Device demonstrated that its new thromboresistant coating may further reduce the risk of device-related thrombus and result in faster and more uniform tissue coverage on the device at 45 days post implant. The findings were also published in JACC Clinical Electrophysiology.

"The data shared at this year's Heart Rhythm meeting showcases the breadth and depth of our cardiology therapies, which spans from diagnosis to treatment of cardiac disease, and highlights the continued growth of our portfolio," said Kenneth Stein, M.D., senior vice president and global chief medical officer, Boston Scientific. "From preclinical data to real-world surveillance, data demonstrated positive outcomes for our FARAPULSE PFA System, the POLARx Cryoablation System, the EMBLEM S-ICD System as well as our WATCHMAN FLX LAAC device, and is evidence of our commitment to providing physicians with innovative technologies that make a meaningful impact on the lives of patients living with heart disease."

About Boston ScientificBoston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit http://www.bostonscientific.com and connect on Twitter and Facebook.

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This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding clinical trials; our business plans and product performance and impact and new and anticipated product approvals and launches. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

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CONTACTS:Steve BaileyMedia Relations(651) 582-4343 (office)[emailprotected]

Lauren TenglerInvestor Relations(508) 683-4479[emailprotected]

*Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.** Use of FARAPULSE in persistent AF patients is outside labeled indications.

SOURCE Boston Scientific Corporation

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Data at Heart Rhythm 2023 Highlight Key Boston Scientific Therapies - PR Newswire