How does Pulse IVL remodel vascular calcification treatment work?
Amplitude Vascular Systems’ core product, the Pulse IVL™ System, utilizes carbon dioxide (CO₂)-driven pulsating pressure wave technology, distinguishing it from traditional electrohydraulic lithotripsy systems. Its working principle involves generating high-frequency pulsating pressure waves externally, which are transmitted through a catheter to a balloon. Within the balloon, these waves are amplified and act on calcified plaques in the vessel wall. The short-duration high-pressure wave impact causes multi-directional fracture of the calcifications, thereby increasing vascular compliance and allowing the vessel to safely dilate and maintain its dilated state.
A key innovation of this technology is the absence of electrodes or laser components within the balloon. The pressure wave is generated externally and transmitted and amplified through the balloon. This design significantly reduces the catheter crossing profile, improving device flexibility and delivery capability.
Unlike traditional IVL catheters that integrate electrodes or laser emitters within the balloon, Pulse IVL™ employs a unique mechanical energy delivery mechanism. After the pressure wave is generated externally, it is transmitted to the balloon via the catheter shaft; the balloon contains no rigid emitter components. This design significantly reduces the catheter crossing profile, improving the device’s flexibility and deliverability, enabling it to traverse more challenging lesions.
Non-compliant balloon AVS is a manufacturer of IVL catheters using non-compliant balloons. Non-compliant balloons exhibit minimal diameter change during expansion, with a nominal pressure of 4 atm and a rated burst pressure of 6 atm. This design allows for more effective vascular dilation while avoiding excessive stretching or trauma to normal vessel walls, which is particularly important in the treatment of severe calcified lesions.
Multi-lumen catheter shaft structure: The catheter shaft contains three functional lumens: an inflation lumen for balloon inflation and deflation (using a 50/50 saline/contrast mixture); a guidewire lumen compatible with standard 0.014-inch guidewires for easy catheter crossing of lesions; and an energy delivery channel that transmits hydraulic pulsations from the generator to the balloon.
Dual radiopaque marking bands: Each end of the balloon features a radiopaque metallic marking band, clearly visible under X-ray, used to precisely determine the balloon’s working length and ensure accurate coverage of the calcified lesion in the treatment area.
The system employs a hydraulic pulsating energy delivery design. The generator converts pressurized CO₂ into hydraulic pulsating waves, which are transmitted along the catheter axis to the balloon at a high frequency of 15 times/second. When the energy wave reaches the balloon and contacts the lesion, it generates a short-duration peak pressure pulse of approximately 50 atm, radiating uniformly and multidirectionally along the entire length of the balloon, forming continuous pulsating force until calcification and rupture.
The catheter features a quick-change design, a working length of 138cm, and is compatible with 6F guiding catheters. It has a tip outer diameter of 0.023 inches and a penetration profile of 0.044-0.047 inches. The system includes safety features such as single-button activation, automatic shutdown (in case of balloon rupture), and a 45-second blood flow restoration lockout. The maximum pulse count can reach 5,000 pulses/case, meeting the needs of treating complex lesions.
In April 2026, Stryker announced the acquisition of AVS, aiming to incorporate its next-generation IVL technology into its peripheral vascular product line, further validating the clinical value of its structural design.
