Amplitude Vascular Systems (AVS), a medical device company dedicated to treating severely calcified arterial disease, has announced the enrolment of its first patient in the U.S. pivotal trial for Pulsatile Intravascular Lithotripsy (PIVL) therapy.

The POWER PAD II clinical study aims to assess the safety and effectiveness of AVS’s Pulse IVL™ System for patients with moderate to severely calcified peripheral arterial disease. The first case was conducted at UnityPoint Trinity Medical Center in Bettendorf, Iowa, by Dr. Nicolas W. Shammas.

In June 2024, AVS received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate the POWER PAD II trial. This study will enrol up to 120 participants, who will be monitored for six months across 20 facilities in the U.S.

AVS is among the first companies to conduct a pivotal IDE trial for peripheral intravascular lithotripsy in the U.S. This milestone marks a significant step towards FDA clearance and market availability for the Pulse IVL™ System.

The innovative technology is designed for effective delivery across complex calcified lesions, potentially reducing overall procedural costs.

UnityPoint Trinity Medical Center is the first hospital to participate in the POWER PAD II Study, having successfully treated the initial U.S. patient with this new approach to Intravascular Lithotripsy.

The device has been noted for its ease of delivery and efficiency in modifying calcium deposits to restore blood flow in patients.

The introduction of this innovative treatment for calcified arterial disease is expected to significantly enhance patient outcomes and overall quality of life. The results from this pivotal trial will provide valuable insights into a promising new treatment option within the field of IVL therapy.




Source: businesswire.com

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