FastWave Medical Receives FDA IDE Approval for Pivotal Artero™ Trial in PAD Treatment
FastWave Medical has recently achieved a significant milestone with the receipt of FDA approval for its Investigational Device Exemption (IDE) application. This approval enables the company to commence a pivotal trial for the Artero™ electric intravascular lithotripsy (IVL) system, aimed at treating patients suffering from peripheral artery disease (PAD). The SPARC trial will involve an enrollment of up to 125 patients across 30 investigational sites, assessing the safety and efficacy of the Artero™ system in addressing calcified peripheral lesions.
The trial will be led by respected figures in the field: Dr. Sahil Parikh, who serves as the Director of Endovascular Services at Columbia University Irving Medical Center, and Dr. Venita Chandra, who is a Clinical Professor of Surgery at Stanford Health Care. These prominent investigators are poised to ensure a thorough evaluation of this innovative technology.
Tristan Tieso, Chief Operating Officer of FastWave Medical, expressed gratitude to everyone involved in reaching this point, recognizing the dedication of employees, physicians, and partners. Tieso emphasized the importance of demonstrating the capabilities of Artero™ through a rigorous IDE trial and highlighted the company's commitment to delivering advanced medical solutions to patients in need.
The Artero™ system is designed to deliver circumferential sonic pressure waves at a frequency of 4 Hz, significantly faster than existing IVL devices. This innovative design allows for a one-click, hands-free operation, and integrates features aimed at improving procedure times while maintaining predictable performance, particularly in complex cases.
Scott Nelson, CEO of FastWave Medical, reiterated the value of teamwork and resilience in reaching this milestone, stating, "I also want to credit the FDA and its review team for being very responsive and keeping our submission moving forward."
Previously, the IDE approval was accompanied by successful results from a first-in-human study concerning FastWave's Artero™ platform, alongside a 30-patient feasibility study of another system, the Sola™ laser-based coronary IVL solution. FastWave continues to build its reputation in the medical technology landscape, being named one of Fierce Medtech's "Fierce 15" companies and recognized as MD+DI's Medtech Company of the Year for 2025.
The company has robust plans for the future, with a focus on advancing its dual-platform IVL systems. In total, FastWave Medical has successfully secured over $50 million in venture capital to fuel its innovative approaches towards tackling arterial diseases.
The Artero™ device's compelling design features address critical challenges that persist in current calcium-modification technologies. By enhancing deliverability and energy output, its implementation seeks to simplify existing procedures while ensuring the safety and efficacy that have contributed to the rapidly increasing acceptance of IVL therapy in clinical practice.
As the trial gets underway, the medical community anticipates insights that could potentially revolutionize the treatment of peripheral artery disease. FastWave Medical stands ready to showcase the capabilities of its groundbreaking technologies in this pivotal study, with hopes of making impactful contributions to patient care in the realm of cardiovascular health.
The trial will be led by respected figures in the field: Dr. Sahil Parikh, who serves as the Director of Endovascular Services at Columbia University Irving Medical Center, and Dr. Venita Chandra, who is a Clinical Professor of Surgery at Stanford Health Care. These prominent investigators are poised to ensure a thorough evaluation of this innovative technology.
Tristan Tieso, Chief Operating Officer of FastWave Medical, expressed gratitude to everyone involved in reaching this point, recognizing the dedication of employees, physicians, and partners. Tieso emphasized the importance of demonstrating the capabilities of Artero™ through a rigorous IDE trial and highlighted the company's commitment to delivering advanced medical solutions to patients in need.
The Artero™ system is designed to deliver circumferential sonic pressure waves at a frequency of 4 Hz, significantly faster than existing IVL devices. This innovative design allows for a one-click, hands-free operation, and integrates features aimed at improving procedure times while maintaining predictable performance, particularly in complex cases.
Scott Nelson, CEO of FastWave Medical, reiterated the value of teamwork and resilience in reaching this milestone, stating, "I also want to credit the FDA and its review team for being very responsive and keeping our submission moving forward."
Previously, the IDE approval was accompanied by successful results from a first-in-human study concerning FastWave's Artero™ platform, alongside a 30-patient feasibility study of another system, the Sola™ laser-based coronary IVL solution. FastWave continues to build its reputation in the medical technology landscape, being named one of Fierce Medtech's "Fierce 15" companies and recognized as MD+DI's Medtech Company of the Year for 2025.
The company has robust plans for the future, with a focus on advancing its dual-platform IVL systems. In total, FastWave Medical has successfully secured over $50 million in venture capital to fuel its innovative approaches towards tackling arterial diseases.
The Artero™ device's compelling design features address critical challenges that persist in current calcium-modification technologies. By enhancing deliverability and energy output, its implementation seeks to simplify existing procedures while ensuring the safety and efficacy that have contributed to the rapidly increasing acceptance of IVL therapy in clinical practice.
As the trial gets underway, the medical community anticipates insights that could potentially revolutionize the treatment of peripheral artery disease. FastWave Medical stands ready to showcase the capabilities of its groundbreaking technologies in this pivotal study, with hopes of making impactful contributions to patient care in the realm of cardiovascular health.
Topics Health）
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