The longest balloon expandable stent graft1-3 is now 6 Fr compatible, unlocking greater accessibility for patients with complex vascular disease.
The lower profile VBX Stent Graft is the same trusted device that physicians have used for years, now equipped with the most 6 Fr compatible configurations among balloon expandable stent grafts available in the United States. 1-3
While the delivery system was improved to enable a lower profile, no changes have been made to the VBX Stent Graft design. The device maintains its valued characteristics and still offers the widest range of diameter adjustability on the market, with configurations up to 79 mm in length.1-3
Professor Andrew Holden, MD, director of interventional radiology at Auckland Hospital in New Zealand, was involved in the first cases with the VBX Stent Graft and says the system has become a core part of his practice.
“Even at the start, I could tell this was something different than anything else we had available at the time,” he said. According to Dr. Holden, he reaches for the VBX Stent Graft time and again for two key reasons: the high radial resistive force, and its conformability.
“I think we’ve learned that with any device that struggles against anatomy, the anatomy is going to win. The VBX Stent Graft conforms to the anatomy,”4 he said.
Dr. Holden, who has spent almost a decade using the device, published data last year showing the extended follow-up results of those early cases.
“The data confirms what we’d already seen for ourselves, which is that when the VBX Stent Graft is used in the iliac arteries, it is associated with sustained durability and a low incidence of needing retreatment,”5 he said.
Five-year follow-up data demonstrated long-term, durable clinical outcomes when used in the treatment of complex aortoiliac occlusive disease—patients showed 89.5% primary patency and 96.1% primary-assisted patency per lesion and 89.1% freedom from target lesion revascularization per subject.5
“In other words, 9 of 10 complex iliac disease patients treated were completely patent at least through 5-year follow-up, but many for even longer,” said Dr. Holden. “In regard to peripheral vascular intervention, that’s an incredible patency to achieve. These patients will hopefully go on to live a long life, so proving the long-term durability of the stent graft is extremely important.”
“Not only does the VBX Stent Graft offer proven patency as well as a broad offering of lengths and diameters, but its balloon technology is unique as well,” said Fakhir Elmasri, MD, a private practice interventional radiologist with Lakeland Regional Health in Florida.
“We are taught to never advance a balloon-mounted stent through a lesion to avoid the stent falling off the balloon,” Dr. Elmasri said. “With the VBX Stent Graft, I have high confidence that the stent graft will not come off the balloon, even while tracking through tortuous anatomy.”
The Gore VBX FLEX Clinical Study, a prospective, multicenter, single-arm study of 134 patients with complex aortoiliac occlusive disease, reviewed 234 device deployments and found that the device had a 100% success rate at providing delivery of the stent to the target lesion without device dislodgement, and 100% stent retention.4
Dr. Elmasri said he also appreciates that the VBX Stent Graft is a covered stent, as it reduces risk of rupture and reocclusion.6
“There is definitely a proven benefit to using a covered stent over a bare metal stent,” he said, citing the covered stent’s ability to exclude plaque, cover vessel ruptures and decrease risk of complications related to distal embolization. 7-9
For Dr. Holden, the VBX Stent Graft is so effective that he would have continued to accept a 7 Fr access sheath in return for what he called “the gold standard technology.” The lower profile device, however, will only enhance physician use and patient benefit, he said.
According to Dr. Elmasri, who recently completed his first cases using the lower-profile VBX Stent Graft, the 1 Fr difference has a huge impact on patients.
“For one thing, a 6 Fr sheath enables access with a radial approach, because attempting it with a 7 Fr could cause damage of the radial artery, especially for patients with smaller arteries,” he said. “Additionally, if I’m doing manual compression, there’s a huge difference between a 6 Fr and a 7 Fr.”
The low-profile compatibility is a win–win update to a system that has proven its clinical effectiveness and is utilized by physicians worldwide—and the data backs up its value.4,5
“Shortly, we will publish an interesting study that shows that even if the upfront cost of the VBX Stent Graft may be higher than that of its competitors when used in the iliac arteries, the greater range of device length options, combined with the lower rates of reinterventions, result in the VBX Device being the most cost-effective balloon expandable covered stent strategy,”10 Dr. Holden said. “So, the two previous barriers to VBX Stent Graft adoption—6 Fr compatibility and cost—are no longer issues.”
The Gore VBX Stent Graft will be featured in the SIR 2024 New Product Showcase. Be sure to stop by Gore’s Booth 512 at the Expo to learn more about this and other Gore solutions.
References
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2023. MD169334.
- LIFESTREAM® Balloon Expandable Vascular Covered Stent [Instructions for Use]. Tempe, AZ: Bard Peripheral Vascular, Inc; 2019. BAW1345700 Rev. 5 06/19.
- iCast covered stent system [Instructions for Use]. Merrimack, NH: Atrium Medical Corporation; 2023. AW009603-EN Rev 11.
- Bismuth J, Gray BH, Holden A, Metzger C, Panneton J; VBX FLEX Study Investigators. Pivotal study of a next-generation balloon-expandable stent-graft for treatment of iliac occlusive disease. Journal of Endovascular Therapy 2017;24(5):629-637. https://journals.sagepub.com/doi/pdf/10.1177/1526602817720463
- Holden A, Takele E, Hill A, et al. Long-term follow-up of subjects with iliac occlusive disease treated with the Viabahn VBX Balloon-Expandable Endoprosthesis. Journal of Endovascular Therapy. In press.
- Society for Vascular Surgery Lower Extremity Guidelines Writing Group, Conte MS, Pomposelli FB, et al. Society for Vascular Surgery practice guidelines for atheroscleroticocclusive disease of the lower extremities: management of asymptomatic disease and claudication. Journal of Vascular Surgery 2015;61(3) Supplement:2S-41S
- Piazza M, Squizzato F, Dall'Antonia A, et al. Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts usingpropensity score modelling. European Journal of Vascular & Endovascular Surgery 2017;54(2):177-185.
- Mwipatayi BP, Sharma S, Daneshmand A, et al; COBEST co-investigators. Durability of the balloon-expandable covered versus bare-metal stents in the Covered versusBalloon Expandable Stent Trial(COBEST) for the treatment of aortoiliac occlusive disease. Journal of Vascular Surgery 2016;64(1):83-94.e1.
- Sabri SS, Choudhri A, Orgera G, et al. Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusivedisease at the aortic bifurcation. Journal of Vascular & Interventional Radiology 2010;21(7):995-1003.
- Warburton TM, Thomas SD, Holden A, Katib N, Varcoe RL. A cost-consequence analysis comparing balloon-expandable covered stents for the management of aortoiliac occlusive disease. Journal of Endovascular Therapy. In press. A Cost-Consequence Analysis Comparing Balloon-Expandable Covered Stents for the Management of Aortoiliac Occlusive Disease - Thomas M. Warburton, Shannon D. Thomas, Andrew Holden, Nedal Katib, Ramon L. Varcoe, 2024 (sagepub.com)
INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm–13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation. CONTRAINDICATIONS: Do not use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the market where this product is available. Rx Only
Products listed may not be available in all markets.
GORE, Together, improving life, VBX, VBX FLEX, VIABAHN and designsare trademarks of W. L. Gore & Associates.
© 2024 W. L. Gore & Associates, Inc. 214395596-EN MARCH 2024
Disclaimers:
This article is sponsored by a SIR Corporate Partner and does not necessarily reflect the views or policies of SIR. SIR assumes no liability, legal, financial or otherwise, for the accuracy of information in this article or the manner in which it is used. The statements made in the column are not intended to set a standard of care and should not be treated as medical advice nor as a substitute for independent, professional judgment.
Views and opinions of physicians expressed herein are their own and do not necessarily reflect those of W. L. Gore & Associates, Inc., (Gore) or constitute any representation, claim, assertion or opinion of Gore. Gore products referenced within are used within their FDA approved/cleared indications. Gore makes not representations as to the surgical techniques, medical conditions or other factors that may be described in this article. The reader is advised to contact the manufacturer for current and accurate information.
