Houston Methodist Hospital is the first institution in the United States to implant a new FDA-approved device that successfully restored blood flow to a patient’s clogged iliac arteries, the three arteries that run from the end of the aorta down to the pelvis and legs.
Jean Bismuth, M.D., a vascular surgeon with the Houston Methodist DeBakey Heart & Vascular Center, was the primary investigator for the VBX FLEX IDE clinical study and the first to implant the new GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft).
“Hardened blockages had narrowed the patient’s right iliac artery by 70 percent and restricted blood flow to the legs, causing the patient to be in severe pain even at rest,” Bismuth said. “Such calcification can also lead to leg cramping, sexual dysfunction, difficulty walking, and even gangrene and amputation. The condition was severely hampering this patient’s quality of life.”
Peripheral arterial disease (PAD) occurs when the vessels that carry blood to the legs, arms, stomach or kidneys become narrow, restricting blood flow to those areas. According to the Centers for Disease Control (CDC) more than 8 million people in the United States have PAD. Risk factors for peripheral arterial disease include smoking, diabetes, high blood pressure, and other factors.
Bismuth says that because the iliac artery tends to be more highly calcified in comparison to other vessels, stents require greater radial strength and flexibility to restore blood flow to a patient’s legs.
“The construct of this device is much different than the other stents used to open up iliac arteries,” Bismuth said. “Most stents are one unit, however, this stent is like a bunch of independent stents within the one stent. It conforms better, and it’s the missing link of what we needed to treat this type of condition.”
Bismuth says there were no recorded incidences of device dislodgement, failures in stent integrity, or device-related serious adverse events during the nine-month trial.
“This first procedure went extremely well and I think the patient’s quality of life is going to dramatically improve.” Bismuth said. “As vascular surgeons we are always looking for new ways to help our patients through a minimally-invasive approach and I believe we have found it with this new stent.”
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