{"id":4263,"date":"2019-11-25T14:00:00","date_gmt":"2019-11-25T20:00:00","guid":{"rendered":"https:\/\/shockwavemedical.com\/safe-and-sound-ivl-facilitated-transfemoral-tavr-study-in-jacc-ci\/"},"modified":"2024-12-09T14:02:15","modified_gmt":"2024-12-09T20:02:15","slug":"tavr-study-jacc","status":"publish","type":"post","link":"https:\/\/shockwavemedical.com\/de\/education\/tavr-study-jacc\/","title":{"rendered":"Safe and Sound: IVL-Facilitated Transfemoral TAVR Study in JACC: CI"},"content":{"rendered":"\n
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42 patients, 42 valves safely implanted through calcified iliofemoral access!<\/p>\n

Read about the multicenter registry results of using Shockwave Intravascular Lithotripsy to preserve Transfemoral TAVR in a recent publication in JACC: Cardiovascular Interventions.<\/p>\n

Read the publication here<\/a>.<\/p>\n

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

Caution:\u00a0Federal law (USA) restricts this device to sale by or on the order of a physician. Indication for Use\u00a0\u2013 The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries.\u00a0 Not for use in the coronary or cerebral vasculature. <\/span><\/p>\n

Contraindications\u00a0\u2013 Do not use if unable to pass 0.014 guidewire across the lesion \u2022 Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries. <\/span><\/p>\n

Warnings\u00a0\u2013 Only to be used by physicians who are familiar with interventional vascular procedures \u2022 Physicians must be trained prior to use of the device \u2022 Use the Generator in accordance with recommended settings as stated in the Operator\u2019s Manual <\/span><\/p>\n

Precautions\u00a0\u2013 Use only the recommended balloon inflation medium \u2022 Appropriate anticoagulant therapy should be administered by the physician \u2022 Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology <\/span><\/p>\n

Adverse Effects\u00a0\u2013 Possible adverse effects consistent with standard angioplasty include: \u2022 Access site complications \u2022 Allergy to contrast or blood thinners \u2022 Arterial bypass surgery \u2022 Bleeding complications \u2022 Death \u2022 Fracture of guidewire or device \u2022 Hypertension\/Hypotension \u2022 Infection\/sepsis \u2022 Placement of a stent \u2022 Renal failure \u2022 Shock\/pulmonary edema \u2022 Target vessel stenosis or occlusion \u2022 Vascular complications. Risks unique to the device and its use: \u2022 Allergy to catheter material(s) \u2022 Device malfunction or failure \u2022 Excess heat at target site <\/span><\/p>\n

Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions, and adverse events.\u00a0www.shockwavemedical.com<\/a><\/span><\/p>\n\t<\/div>\n\t<\/section>","protected":false},"excerpt":{"rendered":"

Read about the multicenter registry results of using Shockwave IVL to preserve Transfemoral TAVR in a publication in JACC: Cardiovascular Interventions.<\/p>\n","protected":false},"author":2,"featured_media":4249,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":[207],"meta":{"_acf_changed":true,"content-type":"","footnotes":""},"categories":[3],"tags":[],"disease-state":[169,177],"education-topic":[185,189],"product-tag":[285],"specialty":[330,346],"technology":[326],"class_list":["post-4263","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-unkategorisiert","disease-state-peripheral-artery-disease-de","disease-state-pre-tavr-tavi-de","education-topic-best-practices-de","education-topic-case-reviews-de","format-article-de","product-tag-shockwave-m5-de","specialty-interventional-cardiologists-de","specialty-vascular-surgeons-de","technology-peripheral-ivl-de"],"acf":[],"_links":{"self":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts\/4263","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/comments?post=4263"}],"version-history":[{"count":0,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts\/4263\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/media\/4249"}],"wp:attachment":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/media?parent=4263"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/categories?post=4263"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/tags?post=4263"},{"taxonomy":"disease-state","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/disease-state?post=4263"},{"taxonomy":"education-topic","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/education-topic?post=4263"},{"taxonomy":"format","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/format?post=4263"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/product-tag?post=4263"},{"taxonomy":"specialty","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/specialty?post=4263"},{"taxonomy":"technology","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/technology?post=4263"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}