FastWave Medical has announced the completion of its initial first-in-human procedures in the feasibility study of its Sola coronary laser intravascular lithotripsy (IVL) system.
These procedures are part of a multi-centre study aimed at evaluating the safety and performance of Sola in patients suffering from calcified coronary artery disease.
The device is designed to provide precision and control to physicians treating hardened calcium in blood vessels, using laser energy to deliver a consistent 360-degree pressure with each pulse, even in challenging lesions.
The latest milestone follows FastWave’s successful first-in-human study of its Artero peripheral electric IVL system, which achieved 100% procedural success with no adverse events at a 30-day follow-up.
Findings from the Sola study will contribute to shaping FastWave’s regulatory submissions and inform the design of its US pivotal trial, a crucial step towards broader US Food and Drug Administration (FDA) approval.
FastWave co-founder and CEO Scott Nelson said: “Our committed team is aiming to set a new standard in the IVL category, enabling physicians to achieve best-in-class clinical outcomes. This IRB approval represents a major milestone in our mission to deliver transformative technology to physicians and their patients.”
FastWave is engaged in developing next-generation IVL technology, aiming to transform treatment for calcific artery disease in both peripheral and coronary applications.
The company has secured over $40m in venture funding to further develop its dual-platform IVL systems. Its technologies aim to address current limitations in calcium-modification devices by enhancing deliverability, energy output, and usability without additional procedural steps.
Last month, FastWave received Institutional Review Board (IRB) approval to begin the coronary feasibility study with its Sola L-IVL system. The company is partnering with Clinical Accelerator in this regard.
The Sola system features sleek, rupture-resistant balloon catheters and custom laser energy sources that produce precise circumferential sonic pressure waves.
FastWave’s Sola platform is designed to offer improved operator control for safe and effective calcium modification, setting a new standard in coronary artery disease treatment and potentially leading to better patient outcomes.
