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Medtronic launches stent to treat thoracic aneurisms

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Friday, October 9, 2009, 15:00 This news item was posted in medical devices category and has 0 Comments so far.

Captivia Delivery System for the Valiant Thoracic Stent Graft, a minimally invasive treatment for aneurysms and other lesions of the thoracic aorta, from Medtronic Inc has launched in markets outside united states.

Captivia Delivery System for the Valiant Thoracic Stent Graft has received the CE (Conformité Européene) mark recently.

Valiant Captivia system enables physicians to treat a wide range of anatomies with a highly conformable stent graft, with accuracy and ease of delivery to achieve optimal clinical results.

Captivia Delivery System features tip capture for enhanced control of the Valiant Thoracic Stent Graft during deployment and a hydrophilic coating applied to the graft cover to facilitate iliac access and delivery through patients’ vasculature.

Both the Valiant Thoracic Stent Graft and Captivia Delivery System are currently undergoing clinical studies in the United States, where their use is limited to clinical trials approved by the U.S. Food and Drug Administration.

Captivia Delivery System’s hydrophilic coating has also made a significant improvement in stent graft delivery.

Captivia Delivery System is indicated for the treatment of a variety of thoracic aortic lesions, while Valiant Thoracic Stent Graft has emerged as the minimally invasive “system of choice” for thoracic endovascular aortic repair (TEVAR) outside the United States.

In four years of clinical experience, more than 15,000 patients worldwide have received the Valiant Thoracic Stent Graft.

Medtronic, Inc, headquartered in Minneapolis, is the global leader in medical technology.
A pioneer of EVAR, Medtronic has been an innovator and leader in the stent graft industry since the 1990s, with more than 175,000 patients treated with its devices. Medtronic offers the broadest portfolio of stent grafts. Among these are the Talent Abdominal and Thoracic Stent Grafts in the United States, as well as the Endurant Abdominal and the Valiant Thoracic Stent Grafts outside the United States.

What is Thoracic Aortic Aneurysm?

Thoracic aortic aneurysm  is a life-threatening condition that causes significant short- and long-term mortality due to rupture and dissection. Aneurysm is defined as dilatation of the aorta of greater than 150% of its normal diameter for a given segment. For the thoracic aorta, a diameter greater than 3.5 cm is generally considered dilated, whereas greater than 4.5 cm would be considered aneurysmal.

Aneurysms may affect one or more segments of the thoracic aorta, including the ascending aorta, the arch, and the descending thoracic aorta. As many as 25% of patients with TAA also have an abdominal aortic aneurysm. Thoracic aortic aneurysm most commonly results from degeneration of the media of the aortic wall as well as from local hemodynamic forces.

The treatment depends on the location of the aneurysm.

For patients with aneurysms of the ascending aorta or aortic arch, surgery to replace the aorta is recommended if the aneurysm is larger than 5 – 6 centimeters. The aorta is replaced with a fabric substitute.

This is major surgery that requires a heart-lung machine. If the aortic arch is involved, a specialized technique called “circulatory arrest” may be necessary. This involves a period without blood circulation while the patient is on life support.

There are two options for patients with aneurysms of the descending thoracic aorta. If the aneurysm is larger than 6 centimeters, major surgery is done to replace the aorta with a fabric substitute.

Endovascular stenting is a less invasive option. A stent is a tiny metal or plastic tube that is used to hold an artery open. Stents can be placed into the body without cutting the chest.

Instead, tiny, hollow tubes called catheters are inserted into the groin area. The stent is passed through the catheter and into the area of the aneurysm. Not all patients with descending thoracic aneurysms are candidates for stenting, however.

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