Kardium Announces First US Procedures in PULSAR Study of Globe® Pulsed Field System
VANCOUVER, BC — Kardium Inc., a private medical device company that has developed the Globe System for the treatment of atrial fibrillation (AF) using pulsed field ablation (PFA), announced today that the first US patients have been successfully treated in the PULSAR clinical study.
The PULSAR study will enroll over 400 patients for treatment at up to 35 sites in the United States, Canada, and Europe. Dr. Vivek Reddy (Mount Sinai Hospital, New York) and Dr. Atul Verma (McGill University Health Centre, Montreal) are the principal investigators. The first US patients were treated this week at New York’s Mount Sinai Hospital by Dr. Reddy.
The study expands on the successful Globe System PULSE-EU study of 69 patients treated in Prague, Czech Republic. Results of the PULSE-EU study were recently presented at the Heart Rhythm Society Annual Meeting in New Orleans. 100% of veins were acutely isolated, with an average of 22.5 minutes required to isolate all veins. At 3-month remapping, 96% of veins were still durably isolated in patients with paroxysmal AF. No esophageal or brain lesions were identified in these patients.
“As a next generation pulsed field system, the Globe System allows precise delivery of pulsed field energy. Clinical results have shown rapid and durable PV isolation and have so far demonstrated high rates of effectiveness,” said Dr. Vivek Reddy, MD, Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital. “I am excited to be starting the US phase of the PULSAR study here at Mount Sinai.”
“This is a very important milestone for Kardium, as we start the US phase of the PULSAR study,” said Kardium CEO Kevin Chaplin. “We believe the Globe System has the potential to improve outcomes for patients with atrial fibrillation. We look forward to replicating the outstanding results from our PULSE-EU study, here in the US.”
The Globe System features the revolutionary Globe Catheter with 122 gold electrodes, each of which can map the patient’s cardiac anatomy and electrical activity and deliver PF energy to the heart. The Globe Catheter sensors are used to create a proprietary CONTACT™ Map to identify electrodes in contact with cardiac tissue, helping ensure that therapy for atrial fibrillation is effectively delivered.
The PULSAR clinical study is a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study that will be used to validate the safety and effectiveness of the Globe System for regulatory approval and commercial sale.
The Globe System is not currently approved for commercial use.
Kardium Inc. (kardium.com) is a rapidly growing, privately held medical solutions company that has developed an advanced system for atrial fibrillation (AF) treatment: the Globe® System. Kardium has built an outstanding team, who have worked with top medical advisors to develop the Globe System. Founded in 2007 and headquartered in Vancouver, Canada, Kardium has consistently ranked as one of the top companies to work for in British Columbia.
Original source here.