Intravascular lithotripsy for peripheral arterial disease (PAD), developed by Amplitude Vascular Systems (AVS), has reached a significant milestone in its journey toward regulatory clearance and market availability for its innovative Pulse IVL System. The U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to AVS, paving the way for a pivotal trial to explore the efficacy and safety of its pulsatile intravascular lithotripsy therapy.
The POWER-PAD-II clinical study, the focal point of this IDE approval, aims to assess the performance of AVS’s Pulse IVL System in patients grappling with severely calcified peripheral arterial disease. This condition, characterized by the narrowing or obstruction of vessels due to atherosclerosis, affects a substantial population, estimated to be around eight to 12 million individuals in the United States alone.
Central to the trial’s objectives is the enrolment of up to 120 patients with PAD across various regions of the US. These patients, grappling with the debilitating effects of calcification, will undergo treatment with AVS’s Pulse IVL System, with subsequent monitoring for up to six months post-therapy.
AVS’s Pulsatile Intravascular Lithotripsy Set to Revolutionize Peripheral Arterial Disease Treatment
Pulsatile intravascular lithotripsy, the cornerstone of AVS’s therapy, harnesses the power of sound waves to dismantle calcified deposits within vessels. This innovative approach applies high-frequency, pulsatile pressure to fracture calcium lesions, thereby restoring the patency of affected vessels. Notably, there is currently no FDA-approved device employing this method for the treatment of peripheral artery disease.
Mark Toland, Chairman of the AVS board, expressed enthusiasm about this pivotal milestone, highlighting the significance of the IDE approval as AVS advances towards securing FDA clearance and making the Pulse IVL System commercially available. The system, designed to navigate complex calcified lesions and reduce procedural costs, holds promise in revolutionizing peripheral arterial disease treatment paradigms.
Positive Results Propel AVS and Competitors in Advancing Peripheral Arterial Disease Treatments
The POWER-PAD-II clinical study follows the positive outcomes observed in AVS’s preceding POWER-PAD-I trial (NCT05192473), which demonstrated the efficacy of the Pulse IVL System in patients with calcific femoropopliteal arteries. Notable improvements in leg pain, blood flow, and walking ability underscored the therapeutic potential of AVS’s technology.
Amidst AVS’s endeavors, Elixir Medical stands as another player in the calcified lesion landscape, developing its own intravascular lithotripsy system, the LithiX Hertz Contact device. Recent data showcasing the safety and effectiveness of Elixir Medical’s device mirrors the progress in this burgeoning field of innovation.
Beyond AVS and Elixir Medical, a multitude of novel devices are emerging for peripheral arterial disease treatment. Becton, Dickinson and Company (BD) initiated a study evaluating its vascular-covered stent, while ReFlow Medical reported positive outcomes from its retrievable stent designed for infrapopliteal artery lesions. The IDE approval for AVS represents a pivotal step in the journey towards enhancing peripheral arterial disease treatment options, underlining the industry’s commitment to innovation and addressing unmet clinical needs in vascular healthcare.
Resource: Businesswire, June 06, 2024
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