# Pragmatic implementation of intravascular lithotripsy in Japan based on the guidelines for proper use

## TL;DR

This paper describes how Japan implemented a new medical device for treating calcified coronary lesions, adapting guidelines based on clinical evidence and safety data.

## Contribution

The paper presents a pragmatic, evidence-based approach to introducing and regulating intravascular lithotripsy in Japan.

## Key findings

- The 30-day major adverse cardiac event-free rate was 98.3% in the Dual-Prep Registry.
- The procedural success rate was 98.3% for IVL following atherectomy in calcified lesions.
- Guidelines for IVL use were revised in 2025 to include combined atherectomy device use based on registry data.

## Abstract

The Shockwave C2 Coronary Intravascular Lithotripsy (IVL) system (Shockwave Medical, Santa Clara, California), designed to disrupt calcified, de novo coronary lesions, was approved for use in Japan in 2022. Unlike in other countries, where IVL is limited to prestenting use, Japan permitted its broader application, owing to the unique percutaneous coronary intervention environment in this country. Moreover, given that severely calcified lesions in coronary arteries are relatively difficult to treat and that treatment strategies vary widely, clarifying the position of IVL and establishing an algorithm for treating calcified lesions based on available evidence would be helpful in daily clinical practice. Additionally, not all indications for IVL use are supported by evidence; thus, the algorithm should be modified according to the accumulated evidence. To ensure postmarketing safety, it was introduced in stages, in cooperation with relevant academic societies. The guidelines for proper IVL use were established by the academic society. The use of concomitant procedures was restricted during the initial phase of IVL introduction while the guidelines were revised in response to postmarket clinical evidence. The Dual-Prep Registry, designed to evaluate the safety and effectiveness of IVL following atherectomy in severely calcified coronary lesions, was conducted at 20 sites involving 118 patients with 120 lesions. The 30-day major adverse cardiac event-free rate, the primary safety endpoint, was 98.3%, and the procedural success rate, the primary efficacy endpoint, was 98.3%. In 2025, based on the Dual-Prep Registry, the guidelines for proper IVL use were revised to address the combined use of an atherectomy device. Thus, this review demonstrates pragmatic efforts to introduce medical devices in Japan, utilizing the guidelines for proper use.