Pulse IVL
Phase 3- Indications
- Peripheral arterial disease, Coronary artery disease, Carotid artery disease
Company intelligence / Profile preview
Amplitude Vascular Systems
Boston, Massachusetts, United Statesavspulse.com ↗
- Ownership
- Private
- Development stage
- Phase 3
01
Overview
Amplitude Vascular Systems' Pulse IVL™ system has demonstrated efficacy in preclinical and early human studies by safely fracturing vascular calcium to restore blood flow. The pivotal POWER PAD II U.S. IDE trial is ongoing for femoropopliteal arteries, aiming to enroll up to 120 patients at 20 sites. Early results show reduced leg pain and improved walking ability. Additional IDE trials are planned or underway for coronary and carotid indications. The device remains investigational as of mid/late 2025.
- Therapeutic areas
- Cardiovascular
- Modalities
- DeviceIntravascular Lithotripsy (IVL) device using pulsatile pressure waves ("Pulse IVL System")Balloon-based platform for intravascular lithotripsy (PIVL)
- Industry
- Therapeutic Medical Devices
02
Drug pipeline
1 asset03
Partnerships
Jacobs InstituteBioStar CapitalCue Growth Partners
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