FastWave Medical Gets OK to Start IVL Feasibility Study

FastWave Medical, an intravascular lithotripsy (IVL) startup, has earned Institutional Review Board (IRB) approval to begin a coronary feasibility study of its Sola laser IVL (L-IVL) system. The company is partnering with a clinical accelerator, paving the way for its U.S. pivotal trial.

The next-gen Sola L-IVL system helps treat cardiovascular calcium with sleek, rupture-resistant balloon catheters. A custom laser energy source produces actuating, circumferential sonic pressure waves.

“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,” added Scott Nelson, co-founder and CEO of FastWave.

FastWave also expects to begin an investigational device exemption (IDE) pivotal trial later this year for peripheral artery disease treatment 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, Fla.