Valiant™ Captivia™ thoracic stent graft system maintains vessel wall apposition and fixation, regardless of angulation and oversizing.1 Clinically supported by low type Ia endoleak rate (0% at five years).2 The stent graft system has over a decade of worldwide experience and was chosen for over 200,000† patients worldwide. It has five years of clinical data across all descending thoracic aortic pathologies.2–4
Case image courtesy of Dr. Roy M. Fujitani
Results1,5
The Valiant™ Captivia™ stent graft is the only device that maintains complete apposition regardless of angulation and oversizing.
The Valiant™ Captivia™ stent graft system remained apposed to the aortic wall at each increment of neck angulation and degree of oversizing in a simulated environment.
For the other stent grafts tested, lack of device wall apposition was observed between the proximal anchorage segment and the inferior aortic wall.
Angular flexibility and radial strength give the Valiant™ Captivia™ stent graft conformability and optimal seal1,2,5,6
‡ 10–19% device oversizing.
Bench testing may not be indicative of clinical performance.
Risks associated with TEVAR procedures may include rupture, conversion to open repair, or secondary procedures.
Product tested
Proximal apposition at different landing zone angulation
Body apposition at different landing zone angulation
Medtronic Valiant™ Captivia™ system
No lack of apposition (remained apposed)
No lack of apposition (remained apposed)
A
Lack of apposition above 120º
No lack of apposition (remained apposed)
B
No lack of apposition (remained apposed)
Lack of apposition above 110º
C
Lack of apposition above 110º
No lack of apposition (remained apposed)
Features
Continuous seal
How does the design of the Valiant™ Captivia™ stent graft system address continuous seal?
The aorta is elastic, flexible, and moves according to the cardiac cycle.7
Achieving and maintaining a continuous seal is critical in TEVAR durability.1,2,4,8
The Valiant™ Captivia™ system establishes and maintains a continuous seal and optimizes apposition in a dynamic environment.1
Bench testing may not be indicative of clinical performance.
Continuous seal is achieved by the combination of three proximal elements.
Proximal 8-Peak FreeFlo configuration evenly distributes radial force for complete vessel wall apposition and extends past the covered stent graft for additional fixation.5,6
Mini support spring maintains the fabric in a stretched position, minimizing infolding.2–4
First body stent provides appropriate radial force for migration resistance, ensuring stability in dynamic environments.1,2,4,8
Risks associated with TEVAR procedures may include rupture, conversion to surgical repair, or secondary procedures.
Ease of access
Crossing profile is similar to or lower than other thoracic stent grafts for ease of access.
Bench testing may not be indicative of clinical performance.
Precise deployment
Platinum-iridium Figur8 markers provide high visibility for accurate placement.
Three-step deployment with tip capture release provides controlled deployment and precise placement in the thoracic aorta.
Step 1
Slow, controlled deployment for precise placement13
Step 2
Quick deployment option, if desired
Step 3
Tip capture release
Absence of a longitudinal bar allows for enhanced flexibility and kink resistance.1,5,9
Broad selection of proximal and distal components leads to many combinations to customize for a variety of patients.14
Physicians’ perspectives
Clinician experiences with Valiant™ Captivia™ video (03:47)
Watch this video to hear leading clinicians discuss why they choose the Valiant™ Captivia™ stent graft system for their patients.
Dr. Frank Arko accuracy video (03:15)
See how the three-step Captivia™ delivery system enables simple graft adjustment and precise placement within the thoracic aorta.9–12
Dr. Jean Panneton conformability video (03:42) Medtronic consultant
Watch this video and hear Dr. Panneton discuss how Valiant™ Captivia™ is highly flexible and conformable due to its sinusoidal shape, super‑elastic nitinol springs, and lack of a longitudinal bar.1,5,9
Dr. Hitoshi Matsuda dissection video (02:50)
Watch this video and hear Dr. Matsuda review a type B aortic dissection case he treated with TEVAR, which provides a minimally invasive alternative to open surgical repair.
Indications
The Valiant™ thoracic stent graft with the Captivia™ delivery system is indicated for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in patients having the appropriate anatomy, including:
Iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories;
Nonaneurysmal aortic diameter in the range of 18 mm to 42 mm (fusiform and saccular aneurysms/penetrating ulcers), or 18 mm to 44 mm (blunt traumatic aortic injuries), or 20 mm to 44 mm (dissections); and
Nonaneurysmal aortical proximal and distal neck lengths ≥ 20 mm (fusiform and saccular aneurysms/penetrating ulcers), landing zone ≥ 20 mm proximal to the primary entry tear (blunt traumatic aortic injuries, dissections). The proximal extent of the landing zone must not be dissected.
TM* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
† Data on file. Internal global finance report, total Valiant™ Captivia™ cases.
‡ 10–19% device oversizing.
Canaud L, Cathala P, Joyeux F, Branchereau P, Marty-Ané C, Alric P. Improvement in conformability of the latest generation of thoracic stent grafts. J Vasc Surg. 2013;57(4):1084–1089. doi:10.1016/j.jvs.2012.09.019.
Conrad MF, Tuchek J, Freezor R, Bavaria J, White R, Fairman R. Results of the VALOR II trial of the Medtronic Valiant™ Thoracic Stent Graft. J Vasc Surg. 2017;66(2):335–342. doi:10.1016/j.jvs.2016.12.136.
Bavaria JE, Brinkman WT, Hughes GC, et al. Five-year outcomes of endovascular repair of complicated acute type B aortic dissections. J Thorac Cardiovasc Surg. 2022;163(2):539–548.e2. doi:10.1016/j.jtcvs.2020.03.162.
Patel HJ, Azizzadeh A, Matsumoto AH, et al. Five-year outcomes from the United States pivotal trial of Valiant™ Captivia™ Stent Graft for blunt aortic injury. Ann Thorac Surg. 2020;110(3):815–820. doi:10.1016/j.athoracsur.2019.12.028.
Based on internal test report TR4370, Valiant™ Thoracic Stent Graft System kink testing, Rev E.
Drawing Specification. Stent, Assembly, 8-Peak, Formed Wire 15 mm Length, Valiant™ Stent Graft. MS115713-XX.
Mileva N, Velikova T, Velikov T, Vassilev D. Aortic elasticity and cardiovascular risk stratification: A narrative review on the current understanding. J Vasc Dis. 2024;3(1):88–101. doi:10.3390/jvd3010008.
Based on internal test report TR12001, Rev B, Stent radial force of the Valiant™ Thoracic Stent Graft. 2009.
Based on internal test report TR11570, Simulated Use Test Report for Design Verification, Valiant™ Thoracic Stent Graft System, Rev A.
Khoynezhad A, Azizzadeh A, Donayre CE, et al. Results of a multicenter, prospective trial of thoracic endovascular aortic repair for blunt thoracic aortic injury (RESCUE trial). J Vasc Surg. April 2013;57(4):899-905.e1. doi:10.1016/j.jvs.2012.10.099.
Lim CY. Endovascular repair in acute complicated Type B aortic dissection: 3-year results from the Valiant™ US Investigational Device Exemption Study. Korean J Thorac Cardiovasc Surg. 2017;50(3):137-143. doi:10.5090/kjtcs.2017.50.3.137.
Fairman RM, Tuchek JM, Lee WA, et al. Pivotal results for the Medtronic Valiant™ Thoracic Stent Graft System in the VALOR II trial. J Vasc Surg. 2012;56(5):1222-1231.e1. doi:10.1016/j.jvs.2012.04.062.
Valiant™ Captivia™ stent graft system information for use, M333320F001, Rev AA. 2024.
Product Label Tech Info Chart (PLTIC): Valiant™ Captivia™ US Commercial. PLTIC128924-04, Rev 1A. Medtronic data on file.