Johnson & Johnson MedTech has encouraging Omnypulse results, more data backs Varipulse

 Johnson & Johnson MedTech (NYSE: JNJ)

 today announced 12-month pilot data from a study of its investigational Omnypulse platform for AFib.

The Omnypulse platform features the Omnypulse catheter and the Trupulse generator. The company offers the catheter as a large-tip, 12 mm device with Carto 3 mapping system integration. Carto 3 offers 3D heart mapping for electrophysiology procedures, including pulsed field ablation (PFA). The focal catheter features contact-force sensing and bipolar, biphasic pulse delivery with enhanced mapping capabilities. Altogether, it combines PFA therapy and mapping.

Results from OMNY-AF, presented during the 31st Annual AF Symposium in Boston, included 12-month outcomes across a 30-patient pilot cohort. Findings demonstrated 100% acute procedural success with no procedure-associated adverse events. Additionally, 56.7% of cases took place with zero fluoroscopy and 90% of patients achieved primary effectiveness at 12 months.

“The 12-month data provide encouraging early evidence on the OMNY-AF study with promising safety outcomes – no procedure-related adverse events or MRI-detected cerebral lesions – across eight centers in the pilot phase. In my cases during the ongoing OMNY-AF trial, the seamless integration of advanced mapping, ultrasound, and PF Index with contact force were valuable for precise and efficient pulsed field energy delivery,” said Dr. Dinesh Sharma, section head of cardiac electrophysiology at the Naples Heart Institute and the study’s presenting author.

Johnson & Johnson MedTech also has positive Varipulse data

The Varipulse catheter comprises one key piece of the Varipulse platform. [image courtesy of Biosense Webster/Johnson & Johnson MedTech]

Along with Omnypulse data, J&J MedTech shared new findings for its Varipulse PFA platform.

A study shared at the AF Symposium examined the incidence of neurovascular events following the workflow enhancements and the introduction of an optimized irrigation flow rate. The company announced the introduction of optimized irrigation flow rate capabilities earlier this week.

Varipulse sustained a low neurovascular event rate of 0.22% in 6,811 patients after the implementation of both workflow enhancements and the updated irrigation rate. This could prove relevant as, just over a year ago, the company temporarily halted all U.S. cases using Varipulse, having received reports of neurovascular events. After reviewing four reported neurovascular events, the company resumed sales a month later.

Additional Varipulse data added to the body of evidence suppoting the system’s safety profile. That includes a physician survey of 850 procedures with low complication rates. The survey recorded a 1.9% rate of primary adverse events, a 0.2% incidence of neurovascular events and no reported cases of coronary spasm or death. Same-day discharge occurred in 87.9% of patients.

Results from the REAL AF registry showed a low overall acute safety event rate of 0.5% with no neurovascular events as well.

“These data reinforce confidence in the consistency of safety outcomes observed across Johnson & Johnson’s electrophysiology portfolio. As a relatively new energy modality, pulse field ablation technologies should be individually evaluated for safety and reproducibility in atrial fibrillation ablation,” said Dr. Gregory Michaud, chief medical and scientific officer, Electrophysiology, Johnson & Johnson MedTech. “As pulsed field ablation continues to evolve, rigorous evidence generation and transparent data sharing will be essential to advancing the science and enabling the next wave of innovation with this technology.”

https://www.massdevice.com/johnson-johnson-medtech-encouraging-omnypulse-results/