Cooper is one of only a handful of hospitals\u00a0in the tri-state region\u2014and fewer than\u00a040 nationwide\u2014participating in a pivotal\u00a0study of the GORE\u00ae TAG\u00ae Thoracic Branch\u00a0Endoprosthesis (TBE), the first device\u00a0designed specifically for the endovascular treatment of aortic arch lesions.<\/p>\n
It offers a minimally invasive treatment\u00a0for patients with these more complicated aortic aneurysms.<\/p>\n
\u201cTechnology came out about 20 years\u00a0ago that enabled us to endovascularly repair\u00a0aortic aneurysms below the kidney arteries,\u201d\u00a0says vascular surgeon Joseph V. Lombardi,\u00a0MD, FACS, head of the Division of Vascular\u00a0and Endovascular Surgery and director of the Cooper Aortic Center.<\/p>\n
\u201cBut the technology has developed slowly\u00a0for treating thoracic aneurysms and aortic\u00a0arch disease,\u201d he continues. \u201cWhile we can\u00a0treat many thoracic and thoracoabdominal\u00a0aneurysms with an endovascular stent graft,\u00a0there are limitations when the aortic arch\u00a0is involved. As a result, these patients have required open surgical procedures.\u201d<\/p>\n
Not any more\u2014if this new clinical study\u00a0lives up to its promise. The objective of the\u00a0study is to determine the safety and efficacy\u00a0of the TBE in treating lesions of the aortic\u00a0arch and descending thoracic aorta, which includes dissection, trauma or aneurysm.<\/p>\n
This pivotal study follows both an early\u00a0feasibility study conducted in Zones 0-1 with\u00a0the branch device in the brachiocephalic or\u00a0left common carotid arteries, and a feasibility\u00a0study in Zone 2 with the branch device\u00a0in the left subclavian artery. The new pivotal\u00a0study will include up to 40 sites across the\u00a0U.S. that are expected to recruit up to 435\u00a0patients, treating all etiologies requiring proximal graft placement in Zones 0-2.<\/p>\n
\u201cThrough this trial, we can treat these\u00a0arch aneurysms, or thoracic aneurysms with\u00a0arch involvement, endovascularly, through\u00a0the groin,\u201d Dr. Lombardi explains. \u201cWe don\u2019t\u00a0have to put the patient on cardiopulmonary\u00a0bypass or crack the chest, and potentially\u00a0reduce associated complications resulting in\u00a0these existing methods of access.\u201d<\/p>\n
Bottom line, as a commercially available\u00a0device\u2014which it already is in Europe\u2014the\u00a0TBE could offer an important less-invasive\u00a0treatment option for the population of U.S.\u00a0patients with aortic arch disease, a condition\u00a0that traditionally has posed significant challenges\u00a0for both open surgical and endovascular management.<\/p>\n
The limited options currently available\u00a0for treating patients with aortic arch disease\u00a0is one of the reasons that the TBE is the\u00a0first GORE device to receive the new FDA\u00a0Expedited Access Pathway (EAP) designation,\u00a0and among the first medical devices\u00a0to receive this designation in the U.S. This\u00a0pathway is limited to certain medical devices\u00a0that demonstrate the potential to address\u00a0unmet medical needs for life-threatening\u00a0diseases and offer a meaningful patient benefit compared to existing options.<\/p>\n
\u201cThere\u2019s a commitment on the part of\u00a0the Cooper Aortic Center to introduce new\u00a0technology to the South Jersey community\u00a0that enables us to treat more complicated\u00a0aneurysms,\u201d Dr. Lombardi says. \u201cThis trial\u00a0represents a major milestone in our ability to do just that.<\/p>\n
\u201cThe company that makes this device\u00a0(W.L. Gore & Associates, Inc.) is meticulous\u00a0about the hospitals they select to participate\u00a0in this trial,\u201d he adds, noting that selection is\u00a0based on surgical expertise, volume, and national\u00a0stature. \u201cSo being chosen for this trial\u00a0speaks loudly about the quality of Cooper\u2019s aortic program.\u201d<\/p>\n
If you have questions about this study or a patient\u2019s eligibility for enrollment,\u00a0call Dr. Lombardi at 856.968.7067 or email Lombardi-joseph@cooperhealth.edu.<\/p>\n","protected":false},"excerpt":{"rendered":"
Cooper is one of only a handful of hospitals\u00a0in the tri-state region\u2014and fewer than\u00a040 nationwide\u2014participating in a pivotal\u00a0study of the GORE\u00ae TAG\u00ae Thoracic Branch\u00a0Endoprosthesis (TBE), the first device\u00a0designed specifically for the endovascular treatment of aortic arch lesions. It offers a minimally invasive treatment\u00a0for patients with these more complicated aortic aneurysms. \u201cTechnology came out about 20 … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":7,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55,4],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-rmineo","4":"post-1750","6":"format-standard","7":"category-new-initiatives","8":"category-news-updates"},"_links":{"self":[{"href":"https:\/\/blogs.cooperhealth.org\/sjmedicalreport\/wp-json\/wp\/v2\/posts\/1750","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.cooperhealth.org\/sjmedicalreport\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.cooperhealth.org\/sjmedicalreport\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.cooperhealth.org\/sjmedicalreport\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.cooperhealth.org\/sjmedicalreport\/wp-json\/wp\/v2\/comments?post=1750"}],"version-history":[{"count":1,"href":"https:\/\/blogs.cooperhealth.org\/sjmedicalreport\/wp-json\/wp\/v2\/posts\/1750\/revisions"}],"predecessor-version":[{"id":1751,"href":"https:\/\/blogs.cooperhealth.org\/sjmedicalreport\/wp-json\/wp\/v2\/posts\/1750\/revisions\/1751"}],"wp:attachment":[{"href":"https:\/\/blogs.cooperhealth.org\/sjmedicalreport\/wp-json\/wp\/v2\/media?parent=1750"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.cooperhealth.org\/sjmedicalreport\/wp-json\/wp\/v2\/categories?post=1750"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.cooperhealth.org\/sjmedicalreport\/wp-json\/wp\/v2\/tags?post=1750"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}