Pulsatile intravascular lithotripsy uses sound waves to break up calcified portions of vessels. Image credit: Shutterstock / DmitrySteshenko.

The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to Amplitude Vascular Systems (AVS), greenlighting a pivotal trial investigating the company’s pulsatile intravascular lithotripsy therapy.

The POWER-PAD-II clinical study will evaluate the safety and efficacy of AVS’s device, named the Pulse IVL System, for the treatment of patients with severely calcified peripheral arterial disease.

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Peripheral artery disease is the narrowing or blockage of vessels caused by atherosclerosis. The condition affects around eight to 12 million people in the US.

The trial aims to enrol up to 120 patients with peripheral artery disease in the US. Patients will be followed for up to six months after the therapy.

Pulsatile intravascular lithotripsy uses sound waves to break up calcified portions of vessels. The high-frequency, pulsatile pressure fragments calcium lesions and helps restore vessel patency. There is currently no FDA-approved device that uses this approach for peripheral artery disease treatment.

AVS board chairman Mark Toland said: “The IDE approval marks our most significant clinical milestone to date as we approach FDA clearance and market availability for the Pulse IVL System, which is designed to easily deliver therapy across complex calcified lesions and reduce overall procedural costs.”

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The POWER-PAD-II clinical study follows the company’s POWER-PAD-I study (NCT05192473), which demonstrated positive efficacy in patients with calcific femoropopliteal arteries. The system reduced leg pain, increased blood flow and improved walking ability.

Also in the calcified lesion space is Elixir Medical, which, similar to AVS, is developing an intravascular lithotripsy system. The company revealed positive safety and effectiveness data for its LithiX Hertz Contact device last month.

A range of novel devices are in development for the treatment of peripheral artery disease. Becton, Dickinson and Company (BD) enrolled the first subject in a study evaluating its vascular-covered stent in March this year. ReFlow Medical has reported positive data from its retrievable stent, indicated for the treatment of vascular lesions in the infrapopliteal arteries below the knee.