Nitinol stent information for patients : IDEV Technologies

IDEV is leading the way in developing minimally invasive medical technologies to protect and preserve anatomical function.

IDEV is focused on products that are truly differentiated and deliver clear patient benefits.

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Patients

About Peripheral Vascular Disease

Peripheral Vascular Disease (PVD) is a serious condition, affecting patient comfort, lifestyle, and longevity. PVD is caused by obstruction or narrowing of the arteries carrying blood to the legs and hands. Symptoms of PVD include leg pain associated with walking (called vascular claudication) progressing to pain at rest or potentially ischemic gangrene requiring amputation. It is estimated that 27 million individuals in the US and Europe suffer from PVD*. IDEV is currently enrolling the SUPERB IDE trial to study the safety and efficacy of using the SUPERA stent for the treatment of PVD.

CAUTION: This device is not yet approved by the FDA for distribution in the United States for peripheral vascular disease.

About Biliary Strictures

Biliary strictures involve a narrowing of the bile duct, the body's transportation system for bile - a fluid that acts as an essential aid to the digestion of food. Biliary strictures are caused by a variety of conditions, both benign and malignant. Stents, which are commonly used to treat biliary strictures, can act as a scaffolding to reopen the bile duct in order to restore the natural flow of bile. SUPERA is currently approved in the United States for palliative treatment of biliary strictures produced by malignant neoplasms.

Stents & Stent Technology

Stent technology has been used for decades to treat a variety of conditions. Stents are inserted into the body to reopen a natural passageway that has been compromised by disease. Stents are a less invasive alternative to surgery for some conditions, which results in a lower procedure-related complication rate and potentially better outcomes.

While stents offer a less invasive alternative to surgery, a number of problems exist with standard nitinol stent technologies including:

Stent fracture
Insufficient radial strength
Kinking in tortuous vessels

IDEV believes that SUPERA represents a new class of stent, and that its unique design offers greatly improved physical characteristics that may translate into improved clinical outcomes.

* TASC II Inter-Society Consensus for the Management of PAD. "The worldwide burden of peripheral artery disease."

SUPERA® is a different
class of stent.