The company presented results from its admIRE pivotal clinical trial and additional data from the Virtue study at HRS 2024. Both studies evaluated Varipulse for the treatment of cardiac arrhythmias, including AFib.
Biosense Webster’s Varipulse system features the Varipulse catheter, a variable-loop multielectrode catheter. The platform also includes TruPulse generator and the Carto 3 3D cardiac mapping system. Carto integration enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms. The company designed Varipulse to enable pulmonary vein isolation with the versatility of a catheter loop, simple generator user interface and an intuitive mapping system. It also features contact indicators and PF tagging mechanisms.
The company submitted Varipulse for FDA approval at the end of March. If approved, Varipulse would become the third PFA system authorized for treating AFib, following Medtronic and Boston Scientific.
Biosense Webster submitted the results from the admIRE study to support its FDA approval bid.
“The admIRE study demonstrated good safety and effectiveness results,” said Dr. Vivek Reddy, director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York. “Differentiated by its unique Carto 3 system integration, this was the first PFA IDE study to support a substantial number of fluoro-free procedures; 25% of procedures were performed with zero fluoroscopy.”
A look at the data presented by Biosense Webster
One-year data from the pivotal phase of admIRE looked at the safety and efficacy of Varipulse in 277 patients with paroxysmal AFib. It spanned 30 U.S. healthcare centers in the U.S. with 39 total operators.
Biosense Webster reported 75% overall primary effectiveness, with 85% peak primary effectiveness. The study saw a 2.9% overall primary adverse event rate, with no reported incidents of device- or procedure-related death. It also had no reports of atrioesophageal fistula, coronary spasm or hemolysis-related renal failure requiring hemodialysis.
All patients achieved acute procedural success, with 98% having first-pass isolation recorded per vein. The procedure had a median time of 81 minutes in pulmonary vein isolation (PIV)-only procedures. Biosense Webster reported a median procedure time of 90 minutes in all procedures and a fluoroscopy time of seven minutes. Additionally, 43% of patients were able to leave the healthcare facility on the same day of their procedure.
In total, a quarter of procedures took place without fluoroscopy, thanks to Carto 3 integration.
“Findings from the admIRE study add to our comprehensive PFA evidence generation strategy and continue to point to the safety and efficacy of the VARIPULSE™ Platform, and other PFA tools,” said Jennifer Currin, VP, scientific affairs, Cardiovascular & Specialty Solutions, Johnson & Johnson MedTech. “The breadth of data presented by Biosense Webster at this year’s meeting underscores our commitment advancement of knowledge and innovation in the treatment of cardiac arrhythmias.”
Data from the VIRTUE study also evaluated further use of Varipulse in patients more reflective of usual clinical practice. It included patients with paroxysmal and persistent AFib, plus atypical atrial flutter, either as first-time or re-do procedures. Biosense Webster said its inclusion criteria extended beyond typical criteria for catheter ablation trials. For instance, of 125 patients in VIRTUE, only 23% would have met the criteria
Investigators performed ablation beyond PVI in 80% of participants. Biosense Webster says the study showed that Varipulse can treat a variety of AFib patients and those with other arrhythmias with lesions beyond PVI.
