Peripheral Clinical Evidence
In multiple pre-clinical and FIH models, Pulse IVL™ was shown to be effective in simultaneously achieving luminal expansion while producing full-thickness calcium fractures in diseased peripheral arteries.
Pre-Clinical Evidence
With a demonstrated ability to fracture and expand severely calcified arteries without adjunctive devices, Pulse IVL™ delivers promising results for treating calcified arterial disease.
Deep Fractures
When tested in multiple cadaveric models with peripheral artery disease, Pulse IVL™ was effective at achieving luminal expansion and producing full-thickness calcium fractures.
First in Human
In 2023, the 30-day results of our First in Human clinical trial, POWER PAD I, were presented at TCT by Dr. Jon George, demonstrating excellent outcomes in each of the nine patients treated.
9
Patients with calcified femoral-popliteal lesions
20
Lesions treated with 95% defined as a heavily calcified by PARC
195mm
Average calcified lesion length
21% ± 6%
Average post-procedure stenosis vs 77% ± 18% at baseline
0
≥ Grade D dissection
3.0mm ± 0.9mm
Acute luminal gain
This early data set demonstrated Pulse IVL™ could successfully treat patients with significantly challenging lesions — helping increase blood flow and improve their ability to walk.
Pivotal IDE
In June 2024, AVS received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin our pivotal trial for Pulse IVL™. This study will evaluate the safety and efficacy of our system in treating U.S.-based patients with severely calcified peripheral arterial disease.
The POWER PAD II Clinical Trial will enroll up to 120 patients at up to 20 U.S. sites to understand how Pulse IVL™ can help treat calcific femoropopliteal arteries, increase blood flow and improve patients’ ability to walk. This first-of-its-kind peripheral intravascular lithotripsy pivotal IDE trial in the U.S. is the next step in gaining FDA clearance and commercializing the Pulse IVL system.
See ClinicalTrials.gov