The first successful use of the B-Laser Atherectomy System in a “step-by-step” approach (crossing a non-crossable CTO cap without guidewire) for the therapy of patients afflicted by highly complex, arterial occlusive peripheral arterial disease (PAD) as well as the first ever utilization of On-line Photo-Acoustic Monitoring to enhance safety during these procedures was announced today by Eximo Medical, Ltd.
The therapy of highly complex, chronically occluded arteries in patients suffering from PAD often requires highly skilled interventionists and dedicated endovascular devices that add significant burden to the episode of care. The B-Laser Atherectomy System technology enables a “step-by-step” crossing approach using a standard B-Laser™ catheter followed by atherectomy with the same catheter while using standard guidewires.
Under a clinical study in Katowice, Poland, a team led by Professor Waclaw Kuczmik used successfully, without any complications, the B-Laser Atherectomy System in several such cases, including long and severely calcified lesions. In addition, these procedures included the use of Eximo’s future proprietary On-line Photo-Acoustic Signal Monitoring technology. The On-line Photo-Acoustic Signal Monitoring is a novel technology that employs machine learning that will empower interventionists to characterize the material in contact with the catheter tip and provide a warning signal to avoid vessel injury and procedural complications. This technology will further enhance the B-Laser’s™ industry leading safety profile, for the treatment of native stenotic and occluded arteries and in-stent restenosis, and will be especially important as the company continues to progress with the coronary indication.
As previously reported, the B-Laser™ Atherectomy System has commenced commercial activity in the United States, and recently added PIMA Vascular, in Tucson, Arizona as a commercial account. PIMA Vascular is headed by Drs. John P Pacanowski and Luis R Leon Jr., and each clinician has already begun using the B-Laser™ to treat patients affected by highly complex, highly calcific lesions at both the above- and below-the knee arterial segments, that includes antegrade and retrograde pedal approaches.
Dr. Luis Leon commented, “there is a well-known paucity of devices that allows interventionists to cross occlusive lesions in an intraluminal path as opposed to sub-intimal. I am very excited to work with Eximo using the B-Laser in a variety of PAD patients and to incorporate it routinely in our outpatient-based laboratory. The capability to cross chronically occluded arteries without needing to cross with a wire first, and to then be able to perform atherectomy over a wire by using the same catheter represents a welcomed and significant addition to our toolkit as it addresses a real unmet need in our practice. I am very proud to be part of this exciting technology and journey”.
“Eximo is extremely excited with the current commercial progress the B-Laser™ is experiencing in the competitive United States market. We continue to leverage the inherent advantages of our unique short pulse 355nm laser platform to develop novel techniques and expand our system’s utilization and market opportunity. It was a significant milestone for us to show B-Laser’s™ ability to cross a highly calcified lesion using the step-by-step technique without the need to cross with a wire first in very challenging scenarios (including long and severely calcific lesions). I am also excited to see our Photo-Acoustic Monitoring technology successfully employed in clinical cases; we believe this technology in time has the potential to shift therapeutic practice,” stated Yoel Zabar, CEO of Eximo Medical.