Latest news with #VivekReddy
Ottawa Citizen
25-04-2025
- Health
- Ottawa Citizen
Kardium Announces 1-Year PULSAR IDE Study Results for Its PFA Device – the Globe® PF System
Article content VANCOUVER, British Columbia — Kardium Inc., a private medical device company that's advancing the way the world treats atrial fibrillation (AF), announced late-breaking, one-year clinical trial results for its innovative pulsed field ablation (PFA) device—the Globe PF System. These pivotal findings from the PULSAR IDE study were announced at the Heart Rhythm Society (HRS) meeting in San Diego 1, highlighting the safety and efficacy data of the Globe PF System, which is currently under PMA review with the US FDA. Article content Article content Article content Key results included: Article content 'These impressive one‑year efficacy results underscore the advanced catheter design of the Globe PF System,' said Dr. Vivek Reddy, Co-Principal Investigator from The Mount Sinai Fuster Heart Hospital, New York. 'Given the excellent durability achieved by the Globe PF System, the efficacy result is likely approaching the limit of what we can achieve with PV isolation alone.' Article content With just 1.2 applications per vein, the Globe PF System is the true single-shot PFA solution with integrated mapping and ablation built into a single catheter. Article content 'We are very pleased with the study's safety results,' says Dr. Atul Verma, Co-Principal Investigator from McGill University Health Centre in Montreal. 'The Globe PF System has demonstrated an exceptional safety profile and offers many key safety differentiators. Its unique design provides single-shot energy application with precise ablation control that allows us to make individualized patient‑centered treatment decisions.' Article content The PULSAR IDE study is a global, prospective, multicenter, single-arm study to demonstrate the safety and long-term efficacy of the Globe PF System. The study enrolled 183 patients across 12 centers in the United States, Europe, and Canada with symptomatic paroxysmal atrial fibrillation. The data presented at HRS was preliminary and the full data will be included in a publication. Article content 'These are truly outstanding results from the PULSAR IDE study,' said Kevin Chaplin, CEO of Kardium. 'The Globe PF System achieved incredible results for safety, efficacy, durability, PFA applications and procedure times. This study is another big step towards achieving our mission at Kardium of delivering the best treatment for atrial fibrillation.' Article content Atrial fibrillation is the most common type of cardiac arrhythmia and affects more than 8 million people in the United States and nearly 50 million people worldwide. 2 Unlike other catheter ablation systems, the Globe PF System is the only solution of its kind to combine single-shot PV isolation, advanced mapping and atrial ablation into a single catheter. Article content About Kardium Article content We are a rapidly growing, privately held medical solutions company made up of a team of scientists, engineers, creatives and business professionals. Our mission is to deliver the best treatment for atrial fibrillation. Article content Article content CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use. This press release may contain forward-looking statements, which reflect current expectations regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, performance or achievements to be materially different from those expressed or implied by such statements. Article content Article content Article content Article content Article content
National Post
25-04-2025
- Health
- National Post
Kardium Announces 1-Year PULSAR IDE Study Results for Its PFA Device – the Globe® PF System
Article content VANCOUVER, British Columbia — Kardium Inc., a private medical device company that's advancing the way the world treats atrial fibrillation (AF), announced late-breaking, one-year clinical trial results for its innovative pulsed field ablation (PFA) device—the Globe PF System. These pivotal findings from the PULSAR IDE study were announced at the Heart Rhythm Society (HRS) meeting in San Diego 1, highlighting the safety and efficacy data of the Globe PF System, which is currently under PMA review with the US FDA. Article content Article content Key results included: Article content 'These impressive one‑year efficacy results underscore the advanced catheter design of the Globe PF System,' said Dr. Vivek Reddy, Co-Principal Investigator from The Mount Sinai Fuster Heart Hospital, New York. 'Given the excellent durability achieved by the Globe PF System, the efficacy result is likely approaching the limit of what we can achieve with PV isolation alone.' Article content With just 1.2 applications per vein, the Globe PF System is the true single-shot PFA solution with integrated mapping and ablation built into a single catheter. Article content 'We are very pleased with the study's safety results,' says Dr. Atul Verma, Co-Principal Investigator from McGill University Health Centre in Montreal. 'The Globe PF System has demonstrated an exceptional safety profile and offers many key safety differentiators. Its unique design provides single-shot energy application with precise ablation control that allows us to make individualized patient‑centered treatment decisions.' Article content The PULSAR IDE study is a global, prospective, multicenter, single-arm study to demonstrate the safety and long-term efficacy of the Globe PF System. The study enrolled 183 patients across 12 centers in the United States, Europe, and Canada with symptomatic paroxysmal atrial fibrillation. The data presented at HRS was preliminary and the full data will be included in a publication. 'These are truly outstanding results from the PULSAR IDE study,' said Kevin Chaplin, CEO of Kardium. 'The Globe PF System achieved incredible results for safety, efficacy, durability, PFA applications and procedure times. This study is another big step towards achieving our mission at Kardium of delivering the best treatment for atrial fibrillation.' Article content Atrial fibrillation is the most common type of cardiac arrhythmia and affects more than 8 million people in the United States and nearly 50 million people worldwide. 2 Unlike other catheter ablation systems, the Globe PF System is the only solution of its kind to combine single-shot PV isolation, advanced mapping and atrial ablation into a single catheter. Article content About Kardium Article content We are a rapidly growing, privately held medical solutions company made up of a team of scientists, engineers, creatives and business professionals. Our mission is to deliver the best treatment for atrial fibrillation. Article content Article content CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use. This press release may contain forward-looking statements, which reflect current expectations regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, performance or achievements to be materially different from those expressed or implied by such statements. Article content Article content Article content Article content Article content
Business Wire
25-04-2025
- Business
- Business Wire
Kardium Announces 1-Year PULSAR IDE Study Results for Its PFA Device – the Globe ® PF System
VANCOUVER, British Columbia--(BUSINESS WIRE)-- Kardium Inc., a private medical device company that's advancing the way the world treats atrial fibrillation (AF), announced late-breaking, one-year clinical trial results for its innovative pulsed field ablation (PFA) device—the Globe PF System. These pivotal findings from the PULSAR IDE study were announced at the Heart Rhythm Society (HRS) meeting in San Diego 1, highlighting the safety and efficacy data of the Globe PF System, which is currently under PMA review with the US FDA. Key results included: 0% device-related primary safety events 78% 12-month primary effectiveness 100% acute procedural success 25-minute average time to isolate all pulmonary veins 1.2 PFA applications per vein on average "These impressive one‑year efficacy results underscore the advanced catheter design of the Globe PF System,' said Dr. Vivek Reddy, Co-Principal Investigator from The Mount Sinai Fuster Heart Hospital, New York. 'Given the excellent durability achieved by the Globe PF System, the efficacy result is likely approaching the limit of what we can achieve with PV isolation alone.' With just 1.2 applications per vein, the Globe PF System is the true single-shot PFA solution with integrated mapping and ablation built into a single catheter. 'We are very pleased with the study's safety results,' says Dr. Atul Verma, Co-Principal Investigator from McGill University Health Centre in Montreal. 'The Globe PF System has demonstrated an exceptional safety profile and offers many key safety differentiators. Its unique design provides single-shot energy application with precise ablation control that allows us to make individualized patient‑centered treatment decisions." The PULSAR IDE study is a global, prospective, multicenter, single-arm study to demonstrate the safety and long-term efficacy of the Globe PF System. The study enrolled 183 patients across 12 centers in the United States, Europe, and Canada with symptomatic paroxysmal atrial fibrillation. The data presented at HRS was preliminary and the full data will be included in a publication. 'These are truly outstanding results from the PULSAR IDE study,' said Kevin Chaplin, CEO of Kardium. 'The Globe PF System achieved incredible results for safety, efficacy, durability, PFA applications and procedure times. This study is another big step towards achieving our mission at Kardium of delivering the best treatment for atrial fibrillation.' About the Globe PF System Atrial fibrillation is the most common type of cardiac arrhythmia and affects more than 8 million people in the United States and nearly 50 million people worldwide. 2 Unlike other catheter ablation systems, the Globe PF System is the only solution of its kind to combine single-shot PV isolation, advanced mapping and atrial ablation into a single catheter. About Kardium We are a rapidly growing, privately held medical solutions company made up of a team of scientists, engineers, creatives and business professionals. Our mission is to deliver the best treatment for atrial fibrillation. CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use. This press release may contain forward-looking statements, which reflect current expectations regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, performance or achievements to be materially different from those expressed or implied by such statements.
Malaysian Reserve
25-04-2025
- Business
- Malaysian Reserve
CIRCA Scientific Announces FDA Clearance of PeriCross™ Epicardial Access Kit
CIRCA Scientific receives FDA 510(k) clearance for the PeriCross™ Epicardial Access Kit, a novel tine-based system designed to support controlled and efficient subxiphoid access to the pericardial space. Preliminary data from the EASY-R trial (n=21) demonstrated 100% access success, with a mean access time of 3.5 minutes, low fluoroscopy time, and minimal contrast usage. Results are being presented at HRS 2025. ENGLEWOOD, Colo., April 24, 2025 /PRNewswire/ — CIRCA Scientific is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the PeriCross™ Epicardial Access Kit (formerly Rook®), a purpose-built solution designed to enable controlled and efficient access to the pericardial space via a subxiphoid approach. Epicardial access remains a technically demanding step in many electrophysiology and structural heart procedures. The PeriCross system features a unique tine-based retraction mechanism integrated with a 21-gauge micro-puncture needle, allowing physicians to create separation between the pericardium and myocardium prior to needle advancement—a design intended to improve control, support procedural consistency, and streamline workflow. 'The PeriCross system addresses one of the most challenging aspects of epicardial procedures with an elegant and intuitive design,' said Dr. Petr Neuzil, Director of the Cardiac Arrhythmia Service at Na Homolce Hospital in Prague. 'Our early clinical experience has shown that the device performs reliably and efficiently across a range of patient anatomies.' Preliminary results from the first 21 patients enrolled in the EASY-R (Epicardial Access StudY with Rook) clinical trial demonstrate encouraging procedural outcomes1: 100% success rate in achieving pericardial access Mean access time of 3.5 ± 2.2 minutes (range 1–8 minutes). Eight of the 21 cases (38.1%) achieved access in 2 minutes or less Low fluoroscopy burden, averaging 2.1 ± 1.1 minutes Minimal contrast use, with 0.7 ± 0.2 mL required per case Dr. Vivek Reddy, The Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital in New York City, NY, commented, 'PeriCross simplifies a complex step and fits naturally into existing workflows. It's intuitive, efficient, and reduces the variability that often comes with epicardial access.' Preliminary data from the study will be presented at the upcoming Heart Rhythm Society (HRS) 2025 Annual Meeting, taking place April 24–27 in San Diego, CA. Enrollment in the trial is now complete, and full clinical results will be submitted for peer-reviewed publication. 'The FDA clearance of PeriCross represents a significant milestone in our strategy to provide physicians with differentiated access tools for complex cardiac procedures,' said Lee Geist, President & CEO of CIRCA Scientific. 'It's a meaningful addition to our portfolio and reflects our ongoing commitment to a CardioCentric™ approach to procedural innovation.' PeriCross will launch within the U.S. market in the coming months, with further expansion to select international markets expected in 2026. About CIRCA Scientific CIRCA Scientific is dedicated to empowering physicians with innovative technologies that offer unprecedented access and control for complex medical interventions. Guided by a CardioCentric™ approach, we are committed to enhancing procedural success and advancing patient care. For more information on CIRCA Scientific and its portfolio of cardiac solutions, visit © CIRCA Scientific, Inc., 2025. All rights reserved. PeriCross, CardioCentric, CIRCA Scientific, and the CIRCA Scientific logo are trademarks of CIRCA Scientific, Inc. Patents: CAUTION: Federal law restricts this device to sale by or on the order of a physician. Please consult the Instructions for Use for indications, contraindications, warnings, and precautions. 1- Neuzil P, Petru J, Funasako M, Hala P, Skoda J, Weiss P, Reddy VK. A First-in-Human Clinical Experience with a Novel Tine-Based Pericardial Retraction and Needle Technology for Facile Epicardial Access. Poster presented at: Heart Rhythm Society Annual Scientific Sessions; April 24–27, 2025; San Diego, CA.
