Pulse IVL™ System
With its novel MOA to fracture arterial calcium, Pulse IVL™ enables operators to treat a wider range of patients faster, more efficiently, with fewer devices.
How Pulse IVL™ Works
Pulse IVL™ uses high-frequency hydraulic pulsatile pressure waves to fracture arterial calcium. With its unique MOA, improved deliverability and intuitive design, our innovative system gives healthcare providers an effective, efficient tool to restore blood flow, and improve patients’ ability to walk.
Different
Pulse IVL™ uses high-frequency hydraulic pulsatile pressure waves to disrupt calcium, meaning there is no need for stiff emitter elements.
Deliverable
Because there is no need for emitters, Pulse IVL™ has lower balloon profiles and better performance, including distal flexibility and crossability.
Efficient
Pulse IVL™ delivers 15 uniform pulses per second along the entire length of the balloon, creating multi-directional fractures in the calcium. Additionally, our system is the only IVL catheter to use a non-compliant balloon, which provides maximum luminal gain with less vessel trauma.
Easy to Use
With a small console, single-button activation and auto shut-off should the balloon rupture, the Pulse IVL system is incredibly intuitive.
Pulse IVL™ in Action
1. Cross
Cross the lesion with the Pulse IVL™ catheter, delivered over a 0.014” wire. Prime the system to 0.5-1.5 atm to enable energy transmission.
2. PULSE
High-frequency (15/second) pulses are uniformly transmitted from the amplifier, through the catheter shaft, and ultimately through the balloon to the calcium, initiating lithotripsy.
3. FRACTURE
Pulse IVL™ fractures intimal and medial calcium, increasing vessel elasticity.
4. EXPAND
The non-compliant balloon allows for the low-stress expansion of the surrounding soft tissue to maximize luminal gain.
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1 Console
- Small console mounted on standard IV pole for compact footprint
- Indication-agnostic
- Powered by standard Type E CO2 tank commonly found within the hospital
2 Handle
- Intuitive user interface with single button activation
- Ergonomic handle for clinician interaction
3 Amplifier
- 5,000 maximum pulses
- Automatic shut-off in case of balloon rupture
4 Catheter
- 0.014” Guidewire compatible
- 45-second lock-out to restore blood flow
5 Balloon
- Non-compliant, low-profile and resilient for maximum luminal gain
- Automatic shut-off in case of rupture
Proficient from Pre-Clinical to Pivotal IDE
Developed to reduce pain, increase blood flow and improve patients’ ability to walk, Pulse IVL™ is establishing a new treatment option for calcified arterial disease.
Peripheral Clinical Evidence
In several pre-clinical models, Pulse IVL™ was shown to be effective in simultaneously achieving luminal expansion while producing full-thickness calcium fractures in diseased arteries in both concentric and eccentric lesions.
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Coronary Clinical Evidence
Due to the excellent results in treating calcified lesions in peripheral clinical models, we are working to achieve these same beneficial outcomes for patients with coronary artery disease.
Carotid Clinical Evidence
We believe the treatment efficiency benefits of Pulse IVL™ will be especially meaningful in treating carotid artery disease. Plans are underway to expand our system’s capabilities into carotid clinical models.
