#8 Modular Device for Treating Complex Aneurysms

Overview

Aortic aneurysms pose a serious medical problem and when they rupture, the results are catastrophic and deadly.

Aneurysm comes from the Greek word “aneurysma,” meaning, “a widening.” The aorta is the largest artery in the body and is the primary artery that carries blood from the heart and lungs to the head and rest of the body. Generally, about an inch in diameter, the aorta is shaped like a candy cane, rises out of the heart, and then rounds down towards the abdomen. Over the course of a lifetime, it transports 200 million liters of blood and has to withstand the pressure of three billion or so heartbeats.

When someone has an aneurysm, there is a weak balloon-like bulge in the wall of the aorta that causes the diameter to sometimes double in size over a period of months or years. Abdominal aortic aneurysms, the most common, occur in the section of the aorta that passes through the abdomen. Thoracic aortic aneurysms occur in the portion of the aorta that passes through the chest. Aneurysms are irreversible and the risk is that, as the aneurysm grows larger over time, it will rupture, triggering massive internal bleeding, shock, and loss of consciousness.

Death is imminent in more than half of the cases, even for those who are able to have emergency surgery. Aortic aneurysms are the 13th leading cause of death in the United States, with over 15,000 fatalities annually. Most of these deaths could have been avoided with proper monitoring and treatment.

Aneurysm treatment depends upon the size and location of the aneurysm and the patient’s overall health. If the aneurysm is large (5.5 to 6 cm in diameter), enlarging rapidly, or leaking, then minimally invasive endovascular repair is the preferred treatment. This entails special tests to visualize the aneurysm followed by selection of a stent graft to fit the body. 

During the surgical procedure, a catheter is inserted through the femoral artery in the leg and snaked up to the aneurysm, where it is positioned to release the stent graft within the aorta. The underlying metallic stent portion of the fabric graft immediately expands and holds it in place within the aorta, reducing pressure on the aorta. Blood flows through the graft to arteries that go to the legs and, over time, the aneurysm eventually shrinks.

Unfortunately, as many as 20 to 40% of people with aortic aneurysms have anatomies that are not suitable for the grafts that are currently marketed, nor are they candidates for the more demanding open surgical repair procedure.

However, thanks to a new innovative fenestrated stent graft system, surgeons can now treat patients with these complex aneurysms without having to take detailed measurements and then wait for weeks, sometimes months, for the customized endografts to be delivered.

The FDA recently approved a multicenter trial of the modular stent device for aneurysms that come close to the renal artery. The device incorporates individual branches to both renal arteries and the superior mesenteric artery. Taken “off-the-shelf” by a surgeon, it can be used for both elective and urgent cases involving the renal arteries.

The new modular stent graft system represents a giant leap forward from prior aortic aneurysm technologies. Not only does it offer a significant reduction in morbidity and ICU stay, but more importantly, it allows an application of life-saving technology to high-risk patients who never could have been treated for their aneurysms.

Where Are They Now

Representing the next frontier in aortic aneurysm endovascular repair, the branched and fenestrated endografts market is expected to grow from $50 million in 2013 to at least $900 million by 2020 as they become more readily available ‘off-the-shelf’.

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