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Unlike other countries where IVL is limited to prestenting, Japan enabled broader use due to its specific percutaneous coronary intervention environment and the clinical difficulty and variability of treating severely calcified lesions. A pragmatic, evidence-updated algorithm and stagewise introduction were implemented with academic societies to ensure postmarketing safety, with restricted concomitant procedures early on. The Dual-Prep Registry (20 sites, 118 patients, 120 lesions) showed 98.3% 30-day major adverse cardiac event-free rate and procedural success rate, and the guidelines were revised in 2025 to address combined atherectomy use.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/pragmatic-implementation-of-intravascular-lithotripsy-in-japan-based-on-the-guidelines-for-proper-use-review-article/468062/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/pragmatic-implementation-of-intravascular-lithotripsy-in-japan-based-on-the-guidelines-for-proper-use-review-article/468062.png","ImageObject",300,407,{"name":92,"@type":93},"Emma Wilson","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-30",true,{"@type":102,"interactionType":103,"userInteractionCount":52},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is the purpose of intravascular lithotripsy (IVL) in this review?","Question",{"text":112,"@type":113},"IVL is used to disrupt calcified coronary lesions, and the review focuses on establishing its position and a treatment algorithm for managing calcification in daily practice.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How did Japan’s IVL approval and use differ from other countries?",{"text":117,"@type":113},"Japan permitted broader application rather than limiting IVL to prestenting use, reflecting Japan’s percutaneous coronary intervention environment.",{"name":119,"@type":110,"acceptedAnswer":120},"What evidence from the Dual-Prep Registry supported guideline revisions?",{"text":121,"@type":113},"The registry evaluated safety and effectiveness after atherectomy in severely calcified lesions, reporting a 30-day major adverse cardiac event-free rate of 98.3% and a procedural success rate of 98.3%, which informed subsequent guideline updates in 2025.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},468062,1791047050,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":52,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":34,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144,"preview_page_count":4},3848291630094,"https://eur-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","Cardiovascular Intervention and Therapeutics (2026) 41:29–35  \n[https://doi.org/10.1007/s12928-025-01224-4](https://doi.org/10.1007/s12928-025-01224-4)  \nREVIEW ARTICLE  \nPragmatic implementation of intravascular lithotripsy in Japan based on the guidelines for proper use  \nTakeshi Shiba1,5 · Masato Nakamura2 · Ken Kozuma3 · Teruyasu Sugano4 · Koichi Aizawa1 · Naoyuki Yabana1 · Kensuke Ishii1  \nReceived: 3 November 2025 / Accepted: 25 November 2025 / Published online: 3 December 2025 © The Author(s) 2025, modified publication 2025  \nAbstract  \nThe 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 atherectomyin 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.  \nKeywords Guidelines for proper use · Intravascular lithotripsy · Percutaneous coronary intervention  \n􀀍 Takeshi Shiba [shiba-takeshi@pmda.go.jp](shiba-takeshi@pmda.go.jp)  \n1 Pharmaceuticals and Medical Devices Agency, Tokyo, Japan  \n2 Division of Minimally Invasive Treatment in Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan  \n3 Department of Cardiology, Teikyo University Hospital, Tokyo, Japan  \n4 Department of Cardiology, Saiseikai Yokohamashi Nanbu Hospital, Yokohama, Kanagawa, Japan  \n5 Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency, 3-2-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan  \nIntroduction  \nMedical devices evolve rapidly; thus, their appropriate use may change based on clinical evidence. Hence, rebalancing between premarketing and postmarketing may be crucial and useful for the approval of their use. To restore the balance and to introduce innovative medical devices appropriately into the medical setting, establishing guidelines for proper use in cooperation with relevant academic societies and planning training programs for physicians have been considered important. Opportunities for such initiatives have been increasing in recent years. Guidelines for proper use play a significant role in medical device utilization, owing not only to the device’s performance but also the wide-ranging factors that affect treatment outcomes. Such factors include the type of patients, the type of facility and physicians, and the manner of using the device. Generally,  \npremarket clinical trials are co","cbCaidhoU5Q1ePxp","https://ap.wps.com/l/cbCaidhoU5Q1ePxp","pdf",1172520,"English","# Abstract\n# Introduction\n## Rationale for guidelines and postmarketing evidence\n## Japan approval of IVL and early evidence-based restrictions","[{\"question\":\"What is the purpose of intravascular lithotripsy (IVL) in this review?\",\"answer\":\"IVL is used to disrupt calcified coronary lesions, and the review focuses on establishing its position and a treatment algorithm for managing calcification in daily practice.\"},{\"question\":\"How did Japan’s IVL approval and use differ from other countries?\",\"answer\":\"Japan permitted broader application rather than limiting IVL to prestenting use, reflecting Japan’s percutaneous coronary intervention environment.\"},{\"question\":\"What evidence from the Dual-Prep Registry supported guideline revisions?\",\"answer\":\"The registry evaluated safety and effectiveness after atherectomy in severely calcified lesions, reporting a 30-day major adverse cardiac event-free rate of 98.3% and a procedural success rate of 98.3%, which informed subsequent guideline updates in 2025.\"}]","Pragmatic implementation of intravascular lithotripsy in Japan based on the guidelines for proper use - Review Article | PDF",1790773720,18]