Latest news with #VivekReddy
Medscape
26-06-2025
- Health
- Medscape
New Pulsed-Field Ablation Device Found Effective at 1 Year
SAN DIEGO — Building on the success of a growing number of devices employing pulsed field ablation to control treatment-resistant paroxysmal atrial fibrillation (AF), a new spherical device produced the highest rate so far of sustained pulmonary vein isolation and freedom from the arrhythmia at 1 year. The results, characterized as 'unprecedented,' relate to the device's multielectrode array that can map, pace, and ablate for a single-shot pulmonary vein isolation in most patients, according to Vivek Y. Reddy, MD, director of Cardiac Arrhythmia Services at the Mount Sinai Health System in New York City. Reddy presented data from the PULSAR IDE pivotal trial of the technology at the 2025 annual meeting of the Heart Rhythm Society. The experimental evidence that ultra-rapid high-voltage electrical pulses provide more consistent and durable pulmonary vein isolation than radiofrequency and other commonly used forms of ablation led to the first approval in the US of a device for pulse field ablation in late 2023. Others quickly followed. Durable AF Suppression an Unmet Need Reddy said pulsed field ablation fills an unmet need in cardiology. 'Creating durable pulmonary vein isolation is critical to improve the long-term freedom from recurrent atrial arrhythmia,' he said. The Globe Pulsed Field System (Kardium Inc.) is a globe-shaped device with a diameter of about 30 mm that clinicians navigate to the pulmonary vein ostium with fluoroscopy. There are 122 gold-plated electrodes mounted on the 16 ribs that provide the structure for the sphere. The multicenter single-arm trial enrolled 164 patients directly into the pivotal trial; 19 others were rolled in from an earlier phase study. All 183 patients had treatment-resistant or treatment-intolerant paroxysmal AF. On the primary efficacy endpoint of freedom from treatment failure 1 year after the procedure, 78% achieved durable control of AF. The only safety event was a hemorrhagic stroke in a patient with severe hypertension. No procedural safety events were reported. 'The efficacy result is likely approaching the limit of what we can achieve with pulmonary vein isolation alone,' Reddy said. New Device Maps Electrical Activity The spherical shape was inspired by preclinical data suggesting higher electrical field strength and greater proximity to cardiac tissue are among the variables that determine the durability of pulmonary vein isolation. However, the Globe Pulse Field device also is able to calculate atrial chamber geometry and map electrical activity in order to deliver pulsed field ablation for what Reddy called 'single-shot' pulmonary vein isolation. In a smaller first-in-human study with the device, 21 patients were assigned to either single-shot ablation or to a sequence of three pulses, but researchers observed no difference in the rate of success (100% in both groups) or in adverse events (zero in both groups). Procedure time was shorter (73.2 vs 93.7 minutes, respectively), and the proportion of patients with durable pulmonary vein isolation (100% vs 30%, respectively) was higher after the 'single-shot,' according to Reddy, who was also the senior author of the pilot study. In the PULSAR IDE trial, the mean mapping time was 9.1 minutes, the mean transpired ablation time was 25.5 minutes, the median left atrial catheter dwell time was 59.9 minutes, and the median procedure time was 95.8 minutes. In a 33-patient substudy that looked for moderate or severe pulmonary vein narrowing, no such events were seen. Pulsed field ablation is a nonthermal but irreversible form of ablation that causes cell death by several mechanisms but acts preferentially on myocardial tissue while sparing the esophagus and phrenic nerve, Reddy said. In the pivotal PULSED AF trial for the first approved pulsed-field ablation device, PulseSelect (Medtronic), 66.2% of patients achieved the composite efficacy endpoint of freedom from procedural failure and recurrence of arrhythmia. PulseSelect is not spherical. This device has nine electrodes and includes mapping and precision delivery of energy, according to promotional descriptions. Pivotal trials with the subsequently approved FARAPULSE (Boston Scientific) and VARIPULSE (Johnson & Johnson) devices generated similar results using comparable measures of effectiveness. In the ADVENT trial of the FARAPULSE device, 73.3% of patients achieved the primary efficacy endpoint. In the AdmIRE trial of VARIPULSE, roughly 75% of patients reached the primary efficacy endpoint. Dhanunjaya D.J. Lakkireddy, MD, executive director of the Kansas City Heart Rhythm Institute in Overland Park, Kansas, called the latest data encouraging, but 'one has to be cautiously excited about these supersized single-shot systems,' he warned. Large single-shot devices like Globe Pulsed Field are effective for rapid ablation, but they have the potential for 'collateral effects on the atrial and neighboring ventricular myocardium.' The chances of such damage over the long term are 'largely unknown.' Reddy reported financial relationships with more than 50 pharmaceutical and device companies, including Kardium, which provided funding for the PULSAR IDE trial. Lakkireddy reported no relevant conflicts of interest.
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.
