{"id":8980,"date":"2021-08-23T22:50:00","date_gmt":"2021-08-24T03:50:00","guid":{"rendered":"https:\/\/shockwavemedical.com\/education\/ivl-not-an-eccentric-option-for-eccentric-calcium\/"},"modified":"2024-12-11T11:27:44","modified_gmt":"2024-12-11T17:27:44","slug":"ivl-not-an-eccentric-option-for-eccentric-calcium","status":"publish","type":"post","link":"https:\/\/shockwavemedical.com\/en-eu\/education\/ivl-not-an-eccentric-option-for-eccentric-calcium\/","title":{"rendered":"IVL: Not an Eccentric Option for Eccentric Calcium"},"content":{"rendered":"\n
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Eccentric calcium has challenged current modalities\u2019 ability to adequately modify calcium due to several device-dependent factors. NC balloons often expand the healthy, non-calcified side of the artery, while high pressure or cutting balloons may result in disruption or dissection of healthy intima. Even atherectomy devices are limited due to wire bias that may often result in nonuniform ablation of calcium leaving the calcified plaque untouched.<\/p>\n

Prof. Carlo Di Mario, Director of Structural Interventional Cardiology at the Careggi University Hospital in Florence, Italy and Prof. Holger Nef, Associate Director at Giessen University Hospital in Germany, shared their experience treating eccentric calcified coronary lesions with Shockwave IVL.<\/p>\n

Read the\u00a0Cardiovascular News article here<\/a> about the challenges of tackling eccentric calcium and the data supporting the safety and efficacy of Shockwave IVL in modifying both concentric and eccentric calcium.<\/p>\n

Download the\u00a0Cardiovascular News PDF here<\/a>.<\/p>\n

\n

Coronary Important Safety Information:<\/span><\/strong><\/p>\n

In the United States: Rx only.<\/span><\/p>\n

Indications for Use\u2014The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2\u00a0Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic\u00a0de novo\u00a0coronary arteries prior to stenting. <\/span><\/p>\n

Contraindications\u2014The Shockwave C2\u00a0Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or cerebrovascular arteries. <\/span><\/p>\n

Warnings\u2014 Use the IVL Generator in accordance with recommended settings as stated in the Operator\u2019s Manual. The risk of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment, including IVL. Appropriate provisional interventions should be readily available. Balloon loss of pressure was associated with a numerical increase in dissection which was not statistically significant and was not associated with MACE.\u00a0 Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure.\u00a0 IVL generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required.\u00a0 In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy. <\/span><\/p>\n

Precautions\u2014 Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating.\u00a0Appropriate anticoagulant therapy should be administered by the physician.\u00a0Precaution should be taken when treating patients with previous stenting within 5mm of target lesion. <\/span><\/p>\n

Potential adverse effects consistent with standard based cardiac interventions include\u2013 Abrupt vessel closure \u2013 Allergic reaction to contrast medium, anticoagulant and\/or antithrombotic therapy-Aneurysm-Arrhythmia-Arteriovenous fistula-Bleeding complications-Cardiac tamponade or pericardial effusion-Cardiopulmonary arrest-Cerebrovascular accident (CVA)-Coronary artery\/vessel occlusion, perforation, rupture or dissection-Coronary artery spasm-Death-Emboli (air, tissue, thrombus or atherosclerotic emboli)-Emergency or non-emergency coronary artery bypass surgery-Emergency or non-emergency percutaneous coronary intervention-Entry site complications-Fracture of the guide wire or failure\/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention-Hematoma at the vascular access site(s)-Hemorrhage-Hypertension\/Hypotension-Infection\/sepsis\/fever-Myocardial Infarction-Myocardial Ischemia or unstable angina-Pain-Peripheral Ischemia-Pseudoaneurysm-Renal failure\/insufficiency-Restenosis of the treated coronary artery leading to revascularization-Shock\/pulmonary edema-Slow flow, no reflow, or abrupt closure of coronary artery-Stroke-Thrombus-Vessel closure, abrupt-Vessel injury requiring surgical repair-Vessel dissection, perforation, rupture, or spasm. Risks identified as related to the device and its use:\u00a0Allergic\/immunologic reaction to the catheter material(s) or coating-Device malfunction, failure, or balloon loss of pressure leading to device embolism, dissection, serious injury or surgical intervention-Atrial or ventricular extrasystole-Atrial or ventricular capture. <\/span><\/p>\n

Prior to use, please reference the Instructions for Use for more information on warnings, precautions and adverse events.\u00a0\u00a0https:\/\/shockwavemedical.com\/IFU <\/a><\/span><\/p>\n

Please contact your local Shockwave representative for specific country availability and refer to the Shockwave C2\u00a0instructions for use containing important safety information.<\/span><\/p>\n\t<\/div>\n\t<\/section>","protected":false},"excerpt":{"rendered":"

Eccentric calcium has challenged current modalities\u2019 ability to adequately modify calcium due to several device-dependent factors.<\/p>\n","protected":false},"author":2,"featured_media":8361,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":[203],"meta":{"_acf_changed":true,"content-type":"","footnotes":""},"categories":[17],"tags":[],"disease-state":[159],"education-topic":[183],"product-tag":[],"specialty":[295,328,332,344],"technology":[316],"class_list":["post-8980","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized-en-uk","disease-state-coronary-artery-disease-en-uk","education-topic-best-practices-en-uk","format-article-en-uk","specialty-fellows-residents-en-uk","specialty-interventional-cardiologists-en-uk","specialty-interventional-radiologists-en-uk","specialty-vascular-surgeons-en-uk","technology-coronary-ivl-en-uk"],"acf":[],"_links":{"self":[{"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/posts\/8980","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/comments?post=8980"}],"version-history":[{"count":0,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/posts\/8980\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/media\/8361"}],"wp:attachment":[{"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/media?parent=8980"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/categories?post=8980"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/tags?post=8980"},{"taxonomy":"disease-state","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/disease-state?post=8980"},{"taxonomy":"education-topic","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/education-topic?post=8980"},{"taxonomy":"format","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/format?post=8980"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/product-tag?post=8980"},{"taxonomy":"specialty","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/specialty?post=8980"},{"taxonomy":"technology","embeddable":true,"href":"https:\/\/shockwavemedical.com\/en-eu\/wp-json\/wp\/v2\/technology?post=8980"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}