What is Lithoplasty® Technology?

Lithoplasty Technology integrates the calcium disrupting power of lithotripsy with the familiarity and simplicity of balloon-based interventional devices. Built on a traditional balloon catheter platform, Lithoplasty Devices use the intermittent pulsatile mechanical energy of lithotripsy to disrupt calcium while minimizing soft tissue injury and an integrated balloon to dilate lesions, restoring blood flow.

The Challenge of Rigid Calcium

Unfortunately, most interventional technology today only addresses superficial calcium or doesn’t address calcium at all. Inflating angioplasty balloons to high pressures causes damage to the surrounding soft tissue – the physics of constant high pressures in the presence of calcium preferentially targets, or damages, soft tissue. Adding scoring or cutting elements to the balloon increases the focal force on the soft tissue, but does not address the calcium. Removing calcified plaque through atherectomy only addresses the superficial calcium, damages the surrounding soft tissue and increases the risk of perforation and distal emboli.

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A Disruptive Solution

Lithoplasty Technology does not use high constant pressure or remove calcified lesions; instead, it applies intermittent pulsatile mechanical energy to disrupt both superficial and deep calcium deposits, normalizing vessel compliance prior to controlled, low pressure dilatation.

before

Before1

In the vasculature, the Lithoplasty Balloon Catheter is positioned and dilated to a sub-nominal pressure of 4 atmospheres. At the push of a button, lithotripsy emitters along the balloon deliver a pre-specified level of pulsatile mechanical energy.

during

During1

These pulses are inherently tissue selective, passing through the balloon and the surrounding soft tissue. When they come in contact with calcium, they disrupt it by creating a series of micro-fractures.

after

After1

The vessel, restructured with improved compliance across the lithotripsy-treated area, can now be dilated evenly by inflating the balloon to reference vessel size using low pressure.

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  1. *Under normal conditions of use per the IFU.