VERSONO Medical is celebrating the success of a new pilot study which found its FastWire intravascular medical device to be hugely effective at enabling the treatment of the worst type of arterial blockages, reducing amputation in vulnerable patients threatened by sepsis caused by vascular disease.
Professor Craig Walker, MD, a world-leading vascular specialist and member of VERSONO Medical’s Clinical Advisory Board, presented the results of the FREEFLOW pilot study to the New Cardiovascular Horizons meeting in Chicago on September 23rd, 2023.
VERSONO Medical’s FastWire device uses ultrasonic technology to cross through complex blockages in patients with Critical Limb Threatening Ischemia (CLTI), the most severe and advanced form of peripheral vascular disease (PAD).
CLTI affects eight million people in the United States and accounts for 90% of lower limb amputations. More than 30% of CLTI patients will have a limb amputated within the first year of diagnosis and 60% will die within five years of diagnosis.
Established therapies have had limited success in treating severe blockages in CLTI patients because clinicians cannot get these to cross the blockage, increasing the probability of an amputation. Some 91% of lower limb amputations in Europe and the US each year are a result of CLTI.
VERSONO Medical’s compact device’s flexible FastWire follows the curvature of arteries, carrying ultrasonic waves to the tip of the wire which then crosses through calcified lesions allowing blood flow to be restored in the affected limb.
Professor Walker told the conference of specialists in peripheral vascular medicine that the patients who were treated using VERSONO Medical’s FastWire device had presented with very severe blockages. Two-thirds of the study cohort had already undergone a previous amputation in the opposite limb to the one being treated.
The conference heard that the FREEFLOW pilot study was successful with no adverse events reported. The restoration of the blood flow, Professor Walker said, would likely prevent further amputations in these patients.
The company is now preparing for a larger pivotal study in the USA of the FastWire device in 2024 before bringing the product to market.
VERSONO CEO Finbar Dolan said: “The VERSONO Medical FREEFLOW pilot study represents another positive step on the journey to bringing VERSONO Medical’s FREEFLOW medical device to market. We are honoured and delighted that Professor Craig Walker presented the findings of the study to the New Cardiovascular Horizons meeting in Chicago. Inviting scrutiny of our FastWire technology by some of the world’s leading medical experts is an important step in building confidence that FastWire can transform the treatment of vascular disease in patients across the world.”
VERSONO CTO Hugh O’Donoghue said: “VERSONO Medical’s mission is to transform the treatment of complex vascular disease. Our unique and revolutionary FastWire technology has the potential to make a life-saving difference to people suffering from complex blockages due to Critical Limb Threatening Ischemia (CLTI). The FREEFLOW pilot study is an important step in demonstrating this.”