Pulse Biosciences Achieves Enrollment Target in NANOPULSE-AF IDE Pivotal Clinical Study Evaluating nPulse™ Cardiac Catheter System for Atrial Fibrillation Treatment
Key Highlights
- ➤NANOPULSE-AF enrolled 164 evaluable patients across 15 clinical sites
- ➤Enrollment target reached three months ahead of original nine-month timeline
- ➤Primary endpoints will assess procedural success and safety at six and 12 months
- ➤Pivotal data expected at a future medical society conference
Expert Statements
Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at Mount Sinai Fuster Heart Hospital and National Principal Investigator of the NANOPULSE-AF Study
“The compelling first-in-human dataset from the nPulse Cardiac Catheter System created significant investigator interest within the EP community across the United States.”
Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at Mount Sinai Fuster Heart Hospital and National Principal Investigator of the NANOPULSE-AF Study
“With so many leading centers eager to evaluate this new catheter and nsPFA technology, we were able to activate 15 world-class clinical sites quickly.”
Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at Mount Sinai Fuster Heart Hospital and National Principal Investigator of the NANOPULSE-AF Study
“The rapid learning curve, seamless integration into current practice and efficient workflow allowed operators to enroll steadily once they started.”
Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at Mount Sinai Fuster Heart Hospital and National Principal Investigator of the NANOPULSE-AF Study
“This is one of the fastest-enrolling trials I have seen or participated in.”
Shephal Doshi, MD, FACC, of Pacific Heart Institute and investigator in the NANOPULSE-AF Study
“In my experience to date, the catheter design and one-shot approach have allowed for a straightforward and efficient procedural workflow.”
Shephal Doshi, MD, FACC, of Pacific Heart Institute and investigator in the NANOPULSE-AF Study
“I look forward to seeing the results of the NANOPULSE-AF Study and gaining a better understanding of the technology as the clinical experience continues to grow.”
David Kenigsberg, MD, FACC, FHRS, Chief Medical Officer of Pulse Biosciences
“We are proud of the commitment to quality as well as patient betterment at each study site and pleased by the speed with which this study reached its enrollment target, three months ahead of our original 9-month timeline.”
David Kenigsberg, MD, FACC, FHRS, Chief Medical Officer of Pulse Biosciences
“The enrollment pace reflects the enthusiasm we saw at sites from their first cases- once operators did one or two cases, they were amazed and hooked and eager to do more.”
Pulse Biosciences Achieves Enrollment Target in NANOPULSE-AF IDE Pivotal Clinical Study Evaluating nPulse™ Cardiac Catheter System for Atrial Fibrillation Treatment
Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nano-PFA or nsPFA™) technology, today announced that its NANOPULSE-AF Study has reached its enrollment target of 164 evaluable patients across 15 clinical sites.
Get started
Create a free account to read the full story.
