VERSONO® Medical Ltd 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.
More than 230 million people, aged 25 or older, are living with Peripheral Arterial Disease (PAD). It is prevalent in around 20% of those aged over 65 and, with a rapidly aging population, these numbers are expected to double by 2030. The four main risk factors for PAD include smoking, hypertension, diabetes and high cholesterol.
Alarmingly more than 30 per cent of patients with the most advanced presentation of PAD, CLTI, will have a limb amputated within the first year post diagnosis, even greater concern is that more than 60 per cent of patients diagnosed will die within five years.
CLTI occurs when total blockages form in the arteries of the lower extremities. Over time blood flow reduces, and eventually, as a total occlusion forms, it eventually completely stops blood flow through the artery. The rising risk of sepsis in the ischemic tissues raises the risk of amputation, restoring blood flow can prevent minor and major amputations.
Prof. Walker has already presented the results of the FREEFLOW first in human (FIH) Pilot study at the New Cardiovascular Horizons meeting in Chicago. That found FastWire to be hugely effective at crossing severely calcified long lesions in tibial and Fem Pop arteries, enabling their treatment, reducing the risk of amputation in these the most vulnerable of patients.
VERSONO Medical’s FastWire Technology has been awarded European Innovation Council and Disruptive Technology Innovation Fund Grants. The European Innovation Council’s funds is to assist finalising and commercialising FastWire. The Irish Department of Enterprise Trade & Employment and Enterprise Ireland’s Disruptive Technology Innovation Fund is enabling Versono develop its product portfolio a pipeline of future Clinical indications for FastWire.
VERSONO Medical now employs 22 staff in Parkmore, Galway and is developing its presence in the US. It is focused on getting FastWire into the hands of physicians to help meet a rapidly growing global clinical need in peripheral vascular interventions.
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 Dr 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.”
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