Israel-based Eximo Medical has reported positive results from its first, multicentre human clinical trial in Europe with a hybrid catheter to treat complex lesions in peripheral blood vessels.
The trial, aimed at securing a CE mark approval to introduce the product in the European market, has exhibited a safe, precise and effective solution to treat partial blockage, complete blockage and severe calcification.
In the trial, which included 20 patients and was led by two physicians from Poland, some of the patients, who origianlly required bypass surgery or a leg amputation, were no longer at risk of amputation after the treatment.
The Eximo system is a solid-state ultraviolet laser with a wavelength of 355nm.
It is connected to a hybrid catheter, combining tissue ablation with the laser and resection with a blunt mechanical blade.
Eximo is said to be the first company to combine a 355nm laser with a mechanical blade to facilitating accuracy.
The patented hybrid laser-mechanical blade design removes blockages irrespective of the type of blockage or the size of the blood vessel, enhancing the efficacy and safety of performance while reducing the risk of puncturing the blood vessel.
Eximo CEO Yoel Zabar said: "We are pleased to announce the successful completion of a first-in-human study with a PAD application, which constitutes a significant milestone that will enable the receipt of CE marketing approval in Europe.
"We are proud that thanks to the unique technology developed by our company, we were able to alleviate patients’ suffering and prevent complicated, unnecessary surgeries, which could, in extreme cases, even have led to amputation of the leg.
"The completion of the trial represents an additional significant step toward a multi-participant FDA trial in the United States, a potential market of billions of dollars."
Following the successful trial, the company is said to be pursuing a CE Mark and an FDA approval next year.