FastWave Medical has received approval from the US Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application, allowing the company to begin a pivotal US clinical trial of its Artero electric intravascular lithotripsy (IVL) system for peripheral artery disease (PAD).

The SPARC trial will enrol up to 125 patients across 30 investigational sites. The study will assess the safety and effectiveness of Artero in treating calcified peripheral artery lesions.

Artero is designed to deliver circumferential sonic pressure waves at a frequency of 4 Hz, which the company says is up to four times faster than earlier IVL devices. The system uses a one-click, hands-free operation and has a rupture-resistant design with a low crossing profile, intended to support easier device delivery and more efficient procedures.

The IDE approval follows a first-in-human study of the Artero platform and a 30-patient feasibility study of FastWave’s Sola laser-based coronary IVL system.

The pivotal trial will be led by co-principal investigators Dr Sahil Parikh of Columbia University Irving Medical Center and Dr Venita Chandra of Stanford Health Care.

The trial is expected to provide further clinical evidence on Artero’s performance in treating calcified peripheral lesions and represents another step in FastWave Medical’s development of IVL technologies for vascular disease.

 

Source: prnewswire.com

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