GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System

The device behind the data

GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System

What defines conformability for TEVAR?

Quote from Dittmar Böckler, M.D.

See the comparisons

Bench-top evaluations are intended to demonstrate relative physical characteristics and may not correlate to clinical results.

Why conformability matters

Boufi et al.,1 states that conformability implies adequacy of contact between the device and landing zone. Adverse events such as compression failures and Type I endoleak have been associated with inadequate conformability.2,3

Graphic showing why conformability matters

See case use

Designed for conformability
 

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Watch video: Sukgu Han, M.D. underscores importance of conformability in TEVAR (1:02)

NEXT: See predictable outcomes

  1. Risk Factor Analysis of Bird Beak Occurrence after Thoracic Endovascular Aortic Repair. Boufi, M. et al., European Journal of Vascular and Endovascular Surgery, Volume 50, Issue 1, 37-43.
  2. Incidence and outcomes after infolding or collapse of thoracic stent grafts Kasirajan, Karthikeshwar et al., Journal of Vascular Surgery, Volume 55, Issue 3, 652-658.
  3. New C-TAG device overcome of compression events K. Kasirajan Journal of Cardiovascular Surgery, Volume 53, No. 2, 169-172.
  4. OP869 Farber MA, Krishnasastry KV, Desai N, Starnes BW, Matsumura JS, Tohill BC; TAG 08-02 Clinical Trial Investigators. Five-year outcomes with Conformable GORE® TAG® endoprosthesis used in traumatic aortic transections. Annals of Thoracic Surgery. In press. https://www.sciencedirect.com/science/article/pii/S0003497521010134
  5. OP871 Jordan WD, Desai N, Letter AJ, Matsumura JS. Long-term outcomes of the CTAG thoracic endograft in a prospective multicenter trial. Journal of Vascular Surgery 2021;74(5):1491-1498. https://www.sciencedirect.com/science/article/pii/S0741521421007485
  6. W. L. Gore & Associates. Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection. Bethesda, MD: National Library of Medicine; 2009. NLM Identifier: NCT00908388. Published May 25, 2009. Updated October 27, 2017. Accessed March 1, 2022. Available from: https://clinicaltrials.gov/ct2/show/NCT00908388

eIFU Symbol

INDICATIONS FOR USE IN THE U.S.: The GORE® TAG® Conformable Thoracic Stent Graft is intended for endovascular repair of all lesions of the descending thoracic aorta, including: isolated lesions in patients who have appropriate anatomy, including: adequate iliac/femoral access, aortic inner diameter in the range of 16-42 mm, ≥ 20 mm non-aneurysmal aorta proximal and distal to the lesion; Type B dissections in patients who have appropriate anatomy, including: adequate iliac/femoral access, ≥ 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected, diameter at proximal extent of proximal landing zone in the range of 16-42 mm. CONTRAINDICATIONS: Patients with known sensitivities or allergies to the device materials; patients who have a condition that threatens to infect the graft. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

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