FastWave Medical Receives IRB Approval for Sola™, its Novel Coronary Laser IVL (L-IVL) System

Feasibility study for coronary artery disease will commence ahead of FastWave's expected U.S. pivotal trial.

  MINNEAPOLIS, May 7, 2025 /PRNewswire/ -- FastWave Medical, a pioneering intravascular lithotripsy (IVL) startup, has secured Institutional Review Board (IRB) approval to commence a coronary feasibility study utilizing Sola^™, its novel laser IVL (L-IVL) system. FastWave is partnering with Clinical Accelerator to achieve this milestone, paving the way for its planned U.S. pivotal trial.

FastWave's next-generation Sola^™ L-IVL system empowers physicians treating cardiovascular calcium with sleek, rupture-resistant balloon catheters. With a custom laser energy source that produces actuating, circumferential sonic pressure waves with unmatched precision and consistency, FastWave's Sola^™ platform allows for improved operator control to safely and effectively modify calcium. FastWave aims to set a new bar in coronary artery disease treatment with its Sola^™ L-IVL system, resulting in superior patient outcomes.

"FastWave's laser IVL system is sophisticated, yet very easy to use. It holds a lot of promise for reshaping complex arterial disease treatment, enabling cardiologists to treat calcified arteries with more precision and efficiency," said Dr. Amir Kaki, Director of Mechanical Circulatory Support and High-Risk Coronary Interventions at Henry Ford St. John Hospital.

"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," said Scott Nelson, co-founder and CEO of FastWave.

In addition to this coronary feasibility study, FastWave looks forward to commencing a U.S. Investigational Device Exemption (IDE) pivotal trial this year for the treatment of peripheral artery disease with its Artero^™ electric IVL (E-IVL) system.

"FastWave is taking the reins and rapidly advancing IVL therapy with its differentiated peripheral and coronary systems. On behalf of my fellow interventionalists, we're genuinely excited to have more IVL options to treat patients with complex arterial disease," said Dr. Art Lee, Director of Peripheral Vascular Services at TCAVI in Gainesville, FL.

About FastWave Medical
FastWave Medical is pioneering next-generation intravascular lithotripsy (IVL) technology designed to transform the treatment of calcific artery disease in both peripheral and coronary applications. Founded by industry veterans with extensive startup and multinational medical device experience, FastWave has secured over $40 million in venture funding to date, supporting the advancement of its dual-platform IVL technology.

The company's innovations address key limitations in current calcium-modification approaches through enhanced deliverability, increased energy output, and improved usability, eliminating cumbersome procedural steps while maintaining the simplicity that has driven IVL's rapid clinical adoption. Learn more at https://fastwavemedical.com.

About Clinical Accelerator
Clinical Accelerator is a global CRO specializing in the study of innovative medical device studies by facilitating early entry into the clinic and ensuring fast and efficient implementation of First-in-Human (FIH) and Early Feasibility Studies (EFS). With extensive experience in trial execution, Clinical Accelerator partners with companies of all sizes to bring groundbreaking solutions to patients worldwide. Learn more at https://clinicalaccelerator.com.

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SOURCE FastWave Medical