#USA #Minneapolis #FastWave Medical #Artero IVL #Peripheral Arterial Disease

FastWave Medical's Innovative Step in Peripheral IVL Treatment

FastWave Medical, a pioneering company in intravascular lithotripsy (IVL), has recently announced the appointment of notable vascular specialists to lead its upcoming clinical trial for the Artero™ electric IVL system. This groundbreaking trial aims to assess the safety and effectiveness of this advanced treatment for peripheral arterial disease (PAD).

Appointment of Leading Experts

The company has named Dr. Sahil Parikh, Director of Endovascular Services at Columbia University Irving Medical Center, and Dr. Venita Chandra, Clinical Professor of Surgery at Stanford Health Care, as co-principal investigators. They are joined by an esteemed group of specialists: Dr. Eric Secemsky of Beth Israel Deaconess Medical Center, Dr. Marc Bonaca from the University of Colorado, and Dr. Daniel Clair, Professor and Chair of Vascular Surgery at Vanderbilt University Medical Center. Together, they will guide the clinical strategy for the trial, aiming to address the pressing health issue of PAD.

Understanding Peripheral Arterial Disease

Peripheral arterial disease is a serious condition characterized by the narrowing of arteries, often due to plaque buildup, which restricts blood flow to the legs and lower extremities. In the United States, the statistics are alarming: a limb is amputated every three to five minutes because of complications arising from PAD, and nearly half of patients who undergo amputation may not survive beyond a year. This condition not only impacts quality of life but is also critically under-recognized and under-treated.

The Role of the Artero™ IVL System

The Artero™ IVL system is designed to treat calcified lesions in arteries, which pose significant challenges during peripheral interventions. Dr. Parikh emphasized, "Calcified lesions aren't just a technical challenge; they are a significant barrier to successful procedures." By testing the Artero™ system, the trial aims to determine whether this advanced technology can make a genuine difference in the lives of those afflicted by this disease.

Dr. Chandra added, "It's not just about whether a device works; it's also about how it improves the efficiency of procedures and offers physicians a more predictable tool for treating complex arterial diseases.” The anticipation surrounding the Artero™ system is high, as its unique design promises to enhance the treatment process significantly.

Innovative Features of Artero™

FastWave Medical claims that the Artero™ system operates at an impressive 4 Hz, doubling the speed of existing IVL technology. This system integrates a hands-free, one-click approach that simplifies usage while maintaining high reliability in the performance of procedures, even in patients with complex vascular conditions. Additionally, its rupture-resistant balloon technology ensures that doctors can treat a wider range of calcified lesions with confidence and precision.

Scott Nelson, CEO of FastWave Medical, expressed his vision for the system: "One of our main objectives with Artero™ is to provide a device that enhances a physician's confidence when addressing these challenging cases. By combining speed, simplicity, and reliability, we aim to create a versatile tool for treating calcified lesions effectively."

Looking Ahead

This announcement by FastWave Medical signifies a major step forward not only for the company but also for the field of vascular treatment. As the trial progresses, the implications of the findings could reshape the management strategies for patients suffering from PAD. Furthermore, FastWave is actively expanding its portfolio with ongoing feasibility studies on its other IVL platforms, including a coronary system known as Sola™, which commenced earlier this year.

In conclusion, FastWave Medical's commitment to addressing the challenges posed by PAD using innovative IVL technology showcases its potential to transform patient outcomes and redefine treatment protocols in the medical community. The upcoming trial serves as a beacon of hope for many and is a vital stride in advancing vascular healthcare.