Shockwave - Intravascular Lithotripsy (IVL) Device
Challenging Calcium Made Shockingly Easy. Address the Challenges of Calcium Without Compromising. Predictably Safe - Safely modify calcium while significantly reducing the risk of complications to make procedures more predictable and efficient. Distinctly Intuitive - Simplify the treatment of calcium from the very first case via a unique MOA on an intuitive platform. Consistently Effective - Proven to achieve low residual stenosis across multiple vessel beds by disrupting superficial and deep calcium.
Urologic Lithotripsy
30 years of safety data in kidney stone treatment. Sonic Pressure Waves preferentially impact hard tissue, disrupt calcium, leave tissue undisturbed.
Intravascular Lithotripsy (IVL)
Miniaturized and arrayed lithotripsy emitters create a localized field effect at the site of the calcium. Optimized energy for the treatment of cardiovascular calcium.
- Portable and rechargeable
- No external connections
- Quick & easy setup with no settings
- Simple magnetic connections
- Push-button activated
- Standard interventional technique
- RX & OTW systems
- 0.014" guidewire of your choice
- The IVL Catheter is delivered across a calcified lesion over an 0.014" wire and the integrated balloon is expanded to 4atm to facilitate efficient energy transfer
- An electrical discharge from the emitters vaporizes the fluid within the balloon, creating a rapidly expanding & collapsing bubble that generates sonic pressure waves
- The waves create a localized field effect that travels through soft vascular tissue, selectively cracking intimal and medial calcium within the vessel wall
- After calcium modification, the integrated balloon may subsequently be used to dilate the lesion at low pressure in order to maximize luminal gain
IVL technology leverages the familiarity of angioplasty balloon catheters to provide a safe, effective and intuitively understandable procedure when treating complex calcified lesions.
- Built upon the principles of lithotripsy
- Modifies calcium through shockwaves
- Shockwaves delivered on an intuitive, low pressure balloon platform
- Shockwaves fracture superficial and deep calcium while safely passing through soft tissue
IVL modifies calcium through use of shockwaves, which are a specific form of sonic pressure waves.
The shockwave waveform has a rapid increase of peak pressure for approximately one micro-second, followed by a small negative pressure trough.
In contrast to ultrasound technologies which are characterized by low amplitude but very high frequency waveforms, an acoustic pressure shockwave has a very high amplitude but low frequency.
Fractures occur when the shockwave encounters tissue with differing impedances, such as the transition to superficial and deep calcium.