System Treats Cause of Heart Attacks in Advance

A luminal protector is being used to treat vulnerable "silent" atherosclerotic deposits in the coronary arteries that do not produce symptoms until they rupture with potentially fatal consequences.

The vProtect Luminal Shield system is designed to treat soft, atherosclerotic lesions that may be at risk of rupture, or recently ruptured. The system consists of the self-expanding vascular shield and a rapid exchange delivery system, which is compatible with 0.355 mm (or 0.014") guidewires and 6 French guiding catheters. The usable length is 135 cm with a rapid exchange guidewire lumen of 25 cm. The delivery system consists of a distal outer sheath that houses the luminal shield and an inner body with radiopaque markers at the distal and proximal ends of the shield. The luminal shield itself is constructed from a nickel-titanium alloy with an austenitic finish (AF) temperature between 20 and 25 ºC (the temperature at which the device achieves its full radial force). The shield has a wall thickness less than 70 μm and it was designed to match the elastic properties of complex thin-cap fibroatheromas (TCFA).

Using a combination of ultrasound and optical imaging techniques, clinicians examine the coronary arteries for signs of additional, non-flow-limiting vulnerable plaques, for which patients would not generally receive treatment. Patients with vulnerable plaques that undergo treatment undergo follow-up diagnostic catheterizations 6 months post-treatment, at which time investigators determine the shield's impact. The vProtect Luminal Shield is a product of Prescient Medical (Doylestown, PA, USA).

"We are very good at opening arteries that are blocked, but we have not succeeded in preventing heart attacks related to plaque rupture," said Professor Patrick Serruys, M.D., Ph.D., of Erasmus University (Rotterdam, The Netherlands), who placed the first luminal shield in the left anterior descending (LAD) coronary artery of a patient at Erasmus Medical Center in June 2008. "The vProtect Luminal Shield has demonstrated that it can be safely placed over a vulnerable lesion without rupturing the plaque, and the results at six months are extremely promising. The Shield performed exactly as intended, allowing us to prevent plaque rupture and an acute event, rather than trying to repair the damage after the fact."

"The self-expanding vProtect Luminal Shield minimizes injury on deployment enabling safe placement over rupture-prone vulnerable plaques," said Patricia Scheller, CEO of Prescient Medical. "Given that there are more than 500,000 sudden cardiac deaths in the United States and more than 300,000 in Europe each year, we are pleased that our device addresses untreated vulnerable plaques, the culprit in a majority of sudden cardiac deaths."

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Erasmus University