In the first-in-human procedure, five patients were treated with investigational CellFX nsPFA 360 cardiac catheter at Na Homolce Hospital in Prague, Czech Republic
Pulse Biosciences has announced first human use of CellFX nsPFA cardiac catheter. (Credit: Elisabeth from Pixabay)
US-based Pulse Biosciences has reported the completion of the first five procedures in its first-in-human (FIH) feasibility study with its CellFX nanosecond pulsed field ablation (nsPFA) cardiac catheter.
The company focuses on using its CellFX nsPFA technology to treat atrial fibrillation (AF). The technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue.
In the FIH procedure, the patients were treated with an investigational CellFX nsPFA 360 cardiac catheter integrated with 3D mapping and navigation technologies that include the iMap System and CardioNXT.
The five patients with AF were treated at Na Homolce Hospital in Prague, Czech Republic. All patients were successfully discharged post-completion of the procedure.
Furthermore, the patients will be monitored and assessed in the coming months to evaluate safety and effectiveness with the primary safety endpoint at 30 days.
Pulse Biosciences president and CEO Kevin Danahy said: “As we embark on this new era of advancement in medical device technology, our mission is clear: to revolutionize healthcare with CellFX nsPFA, with the intention of significantly improving clinical outcomes for both patients and physicians.
“Through relentless innovation, unwavering dedication, and commitment to pushing the boundaries of what is possible in bioelectric energy, we are reshaping the future of the treatment for atrial fibrillation with our cardiac catheter in electrophysiology and with our cardiac clamp in cardiothoracic surgery.
“CellFX nsPFA will empower doctors, inspire patients to seek life-altering treatment, and create a world where CellFX nsPFA technology can become a catalyst for healing and hope.”
The company anticipates that the current feasibility study will enrol a maximum of 30 participants.
Patients undergoing therapy will undergo evaluations regularly to determine the safety and efficacy of the interventions.
In the following months, the company plans to offer further details on the FIH surgeries, including the CellFX technology.
In the next few quarters, the company plans to begin the regulatory procedure with the US Food and Drug Administration (FDA) and relevant international regulatory bodies, including Europe.