Gore Scores FDA Nod for More Precise TEVAR Solution

W.L. Gore and Associates has received a nod from FDA for a more precise Thoracic Endovascular Aortic Repair (TEVAR) solution. The Flagstaff, AZ-based company said the Gore Tag Conformable Thoracic Stent Graft with Active Control System provides new precision and predictable patient outcomes in the endovascular repair of aneurysms, transections, and Type B dissections of the descending thoracic aorta. A smaller-diameter primary delivery sleeve gives the device and system a lower profile across 10 device sizes. “Gore has been on the front end and has really defined and established the TEVAR minimally invasive repair of the thoracic aorta going back more than 10 years now,” Eric Zacharias, a vascular business leader at Gore, told MD+DI. “Over that time, we’ve [been able to] broaden the treatment of a range of disease states that need repair of the thoracic aorta.” Zacharias added, “More recently, the change we made was going after the improvement of the delivery system. The [Gore Tag Conformable Thoracic Stent Graft] is known as a device that treats a wide range of anatomies and fits the anatomy really naturally.” The Gore Active Control System provides controlled, two-stage deployment, with primary deployment to an intermediate diameter and a secondary deployment to full diameter. This design allows for continuous blood flow throughout the deployment wit...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news

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Conclusions: High EI of ILT may predict the occurrence of type II endoleaks after EVAR of AAA. PMID: 31621439 [PubMed - as supplied by publisher]
Source: Minimally Invasive Therapy and Allied Technologies - Category: Surgery Tags: Minim Invasive Ther Allied Technol Source Type: research
True Internal mammary artery aneurysms are rarebut rupture has been described.
Source: Annals of Vascular Surgery - Category: Surgery Authors: Tags: Case Report Source Type: research
Aortic endovascular treatment with fenestrated or branched devices (f/bEVAR) requires a connection between the aortic graft and the visceral vessel (VV). However, data on the perioperative and long-term fate of the VVs remain scarce. The aim of our study was to evaluate the VV loss (VVL) according to the type of revascularization performed (fenestrations vs branched) and the necessity for adjunctive visceral procedures (AVPs).
Source: Journal of Vascular Surgery - Category: Surgery Authors: Source Type: research
The durability of endovascular aneurysm repair (EVAR) when compared to open surgical repair (OSR) in younger patients for elective, infrarenal abdominal aortic aneurysms (AAA) remains unclear due to limited follow up.
Source: Annals of Vascular Surgery - Category: Surgery Authors: Tags: Clinical Research, Basic Science Source Type: research
Efforts to achieve optimal seal during endovascular aortic aneurysm repair (EVAR) may produce partial coverage of the lowest renal artery and in some cases even occlusion. This coverage might alter the renal ostial flow, which could finally affect renal function.We sought to evaluate the incidence of renal ostium coverage and its possible effects on renal function.
Source: Annals of Vascular Surgery - Category: Surgery Authors: Tags: Clinical Research, Basic Science Source Type: research
Few centers in the United States have the expertise to manage patients with Thoracoabdominal aortic aneurysm (TAAA). The purpose of this study is to use a nationally representative vascular database to assess the role of hospital volume on outcomes in patients undergoing endovascular repair for TAAA.
Source: Annals of Vascular Surgery - Category: Surgery Authors: Tags: Clinical Research, Basic Science Source Type: research
This review aims to collect all available data on early and late outcomes in patients undergoing fenestrated endovascular aortic aneurysm repair (F-EVAR) for pararenal or juxtarenal abdominal aortic aneurysms (AAAs).
Source: Annals of Vascular Surgery - Category: Surgery Authors: Tags: General Review Source Type: research
Although endovascular repair (EVAR) is the first-line treatment for abdominal aortic aneurysm, type 2 endoleak (EL), which is associated with late sac enlargement or rupture, remains a concern. The present study aimed to assess the influence of type 2 EL on long-term outcomes after EVAR.
Source: Annals of Vascular Surgery - Category: Surgery Authors: Tags: Clinical Research, Basic Science Source Type: research
The aim of this study was to evaluate the safety and effectiveness of endovascular occlusion of the prevertebral subclavian artery (SA) using an Amplatzer vascular plug after prophylactic revascularization with carotid-subclavian bypass (CSB) in the setting of endovascular thoracic stent grafting or open arch repair with frozen elephant trunk.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Source Type: research
We thank Dr Kang and Dr Zhang for their interest in our study and their note regarding the potential relevance of systemic inflammatory disease (e.g. psoriasis) as a risk factor for pulmonary embolism (PE) after endovascular aortic repair (EVAR).
Source: European Journal of Vascular and Endovascular Surgery - Category: Surgery Authors: Tags: Correspondence Source Type: research
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