VERSONO Medical has begun enrolling patients in the FREEFLOW pivotal study for its FastWire System.
FastWire is a truly disruptive technology designed to quickly access previously untreatable complex blockages in arteries, increasing success rates and reducing risk of amputations via endovascular techniques.
As the revolutionary endovascular platform technology enables the treatment of severely diseased arterial blockages, it opens new clinical frontiers for physicians, with the aim of saving limbs from amputation and saving lives for patients globally.
FREEFLOW will evaluate the safety and effectiveness of VERSONO’s FastWire device technology through the FDA-approved Investigational Device Exemption (IDE) study. Subject to the successful completion of the study, the company will seek US market approval to launch FastWire.
The study is being performed in three centres in Lousiana, Tennessee, and Iowa. The first patients have already been enrolled at two of the clinical sites; the Vascular Institute of the Midwest (VIM) in Davenport, Iowa; and the Cardiovascular Institute of the South (CIS) in Houma, Louisiana. Enrolment at the study’s third site, the Vascular Institute of Chattanooga (VIC) in Tennessee, will begin in the coming weeks.
Professor Craig Walker, MD, an internationally renowned leader in the field, is FREEFLOW’s Principal Investigator (PI). He and his team in Louisiana, with Dr Eric Dippel, and his team in Davenport, and Dr Chris Lesar with his team in Chattanooga, have completed initial procedures and intend to complete enrolment and the IDE study over the coming months.
VERSONO Medical’s FastWire System uses a novel proprietary ultrasonic technology developed and patented by the company over the past six years. It can cross through severe, complex blockages in patient’s arteries, above, and below, the knee with Critical Limb Threatening Ischemia (CLTI). The technology has huge potential application in endovascular procedures.
VERSONO CEO Finbar Dolan said:
“The start of the FREEFLOW Pivotal IDE Study is an exciting major milestone on the road to deliver VERSONO Medical’s FastWire System to physicians and meet their need to treat a rapidly growing number of patients with CLTI. The device is designed to assist restoring blood flow in the severest Complex Total Occlusions (CTOs) in vulnerable patients, to help prevent amputation and in the words of the CLI fighters to ‘save limbs and save lives’.”
VERSONO CTO Hugh O’Donoghue said:
“It is a true honour for us to be working with Professor Craig Walker and the wonderful clinical research team in CIS, Dr Eric Dippel and the dynamic team in VIM, and Dr Chris Lesar and the talented team in the VIC. We are really excited about the future and look forward to the successful completion of FREEFLOW pivotal IDE study over the coming months.”