#USA #Minneapolis #FastWave Medical #Sola IVL #Clinical Accelerator

FastWave Medical Secures IRB Approval for Sola™

FastWave Medical, a cutting-edge startup specializing in intravascular lithotripsy (IVL), has recently announced that it has received Institutional Review Board (IRB) approval to initiate a feasibility study for its novel Sola™ laser IVL (L-IVL) system. This crucial approval marks an important step as it sets the groundwork for the company's anticipated pivotal trial in the United States.

The Sola™ L-IVL system is designed to assist physicians in treating calcified coronary arteries, employing innovative technology that includes rupture-resistant balloon catheters. Notably, the system uses a unique laser energy source that generates circumferential sonic pressure waves, offering unmatched precision and consistent results. By enabling enhanced operator control, FastWave aims to transform how cardiovascular calcium is addressed, ultimately improving patient outcomes in coronary artery disease treatment.

Dr. Amir Kaki, who serves as the Director of Mechanical Circulatory Support and High-Risk Coronary Interventions at Henry Ford St. John Hospital, emphasized the system's potential, stating, "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."

Scott Nelson, co-founder and CEO of FastWave, expressed enthusiasm regarding the IRB approval, recognizing it as a pivotal milestone in the company’s mission to deliver transformational technology to both physicians and patients. "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," he stated.

In addition to the feasibility study focused on coronary artery diseases, FastWave Medical is also preparing to launch a U.S. Investigational Device Exemption (IDE) pivotal trial this year targeting peripheral artery disease with another innovative product, the Artero™ electric IVL (E-IVL) system. This dual approach showcases FastWave's commitment to advancing IVL therapy across a spectrum of vascular conditions.

Dr. Art Lee, Director of Peripheral Vascular Services at TCAVI in Gainesville, Florida, echoed the excitement around FastWave’s progress. "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."

About FastWave Medical

FastWave Medical is revolutionizing the field of intravascular lithotripsy (IVL) by introducing next-generation technology aimed at facilitating the treatment of calcific artery disease in both coronary and peripheral applications. Founded by seasoned professionals with extensive expertise in the medical device industry, FastWave has successfully raised over $40 million in venture funding, which supports the progression of its dual-platform IVL technologies.

The company’s innovations address significant shortcomings in current calcium modification techniques, enhancing deliverability, increasing energy output, and improving usability—effectively streamlining procedural steps while maintaining the simplicity that has contributed to IVL's rapid clinical adoption. More information can be found on their official website: FastWave Medical.

About Clinical Accelerator

Clinical Accelerator is a global contract research organization (CRO) that specializes in innovative medical device studies. The organization is dedicated to facilitating early clinic entry and ensuring the fast and efficient implementation of First-in-Human (FIH) and Early Feasibility Studies (EFS). With a wealth of experience in trial execution, Clinical Accelerator collaborates with companies of all sizes to provide groundbreaking solutions to patients worldwide. Visit Clinical Accelerator for more details.