Trinitrate

Boston Scientific is proving itself to be a pivotal force in the pulsed-field ablation space. The Marlborough, MA-based company continues to be at the forefront of PFA with its technology The firm increased its presence recently by obtaining CE mark for the Farapoint Pulsed Field Ablation Catheter, the newest PFA catheter in the company’s electrophysiology portfolio. The CE mark submission was supported by data from Phase II of the ADVANTAGE AF clinical trial, demonstrating the efficacy and safety of the Farapulse PFA Platform and the Farapoint PFA Catheter as an adjunctive treatment for persistent AF and AFL. The study found that 97.9% of the 141 patients who received CTI ablation with the Farapoint PFA Catheter did not experience AFL recurrence, a comparable efficacy rate to the 98% seen with radiofrequency ablation (RFA), the standard of care, studied in Phase I of the trial. Similarly, CTI ablation with the Farapoint PFA Catheter saw comparable safety rates to RFA (2.1% versus 2.0% at 90 days following the procedure), and the administration of prophylactic nitroglycerine during CTI ablation led to zero coronary artery spasms. A sub-analysis showed that the Farapoint PFA Catheter provided significantly greater predictability in CTI applications and overall procedure times compared with RFA. These findings point to real-world procedural reliability, potentially resulting in more consistent workflows and procedural efficiencies. “Pulsed field ablation is already proven to deliver more effective ablation procedures for the treatment of atrial fibrillation, compared with standard radiofrequency ablation and cryoablation treatments,” said Andrea Natale, professor of medicine, Cardiology Division, University of Rome Tor Vergata, Italy. “We are now seeing the promise of PFA in treating atrial flutter, and the FARAPOINT PFA Catheter, along with wider mapping and 3D visualisation abilities of the Farapulse PFA Platform, can offer physicians the ability to optimise workflows and tailor atrial flutter procedures.” There's a race to be on top; the PFA competition doesn't stop Every approval and regulatory move is key in PFA, as Boston Scientific is fiercely competing with larger players in the space that include Medtronic, Johnson & Johnson, and Abbott Laboratories. Medtronic, the first company to score approval for PFA technology, saw its strongest revenue growth in cardiology in over a decade for its most recently reported quarter. Medtronic’s PFA portfolio also led the company’s cardiac ablation solutions revenue to grow 71% worldwide, and 128% in the U.S. “We're on an incredible trajectory with PFA,” said Geoff Martha, CEO and Chairman of Medtronic, according to a recent Seeking Alpha transcript of an earnings call. Boston Scientific reported strong success for its PFA portfolio during an earnings call in October. “We expect global PFA penetration to continue to expand and to exit 2025 at 50% penetration and grow to about 80% by 2028,” Boston Scientific President, CEO and Chairman Mike Mahoney said, according to a Seeking Alpha transcript of the call. “At our recent Investor Day, we shared that we aim to be the market share leaders, not just in PFA but the overall EP market over time.”

[11-21-2025] The Food and Drug Administration is advising consumers not to purchase or use mR.7 SUPER 700000, a product promoted and sold for male sexual enhancement on various websites, including ebay.com, and possibly in some retail stores. FDA laboratory analysis confirmed that mR.7 SUPER 700000 contains sildenafil and tadalafil not listed on the product label. Sildenafil and tadalafil are the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approval of Viagra and Cialis is restricted to use under the supervision of a licensed health care professional. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program: This notification is to inform the public of products potentially marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, pain relief and body building and are often represented as being all natural. Consumers should exercise caution before purchasing these products. FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. For more information: Content current as of: 11/21/2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.