FDA Approves Arterial Vascular Engineering Coronary Stents

Arterial Vascular Engineering Inc. (Santa Rosa, CA) has received premarket approval (PMA) from FDA to begin immediate commercialization of its Micro Stent II and GFX coronary stent systems in the United States. The PMA covers coronary stent diameters of 3.0 mm, 3.5 mm and 4.0 mm and lengths of 6 mm, 9 mm, 12 mm, 15 mm, 18 mm, 24 mm, and 30 mm for the Micro Stent II and diameters of 3.0mm, 3.5 mm and 4.0 mm and lengths of 8 mm, 12 mm, 18 mm, 24 mm, and 30 mm for the GFX stent.

The stents are used as arterial support devices in connection with balloon angioplasty or other minimally invasive treatments of atherosclerosis (the formation of deposits in the arteries). Unlike tubular-slotted or coiled stent designs, the Arterial Vascular stents are constructed of seamless, medical grade stainless steel rings that are precision-formed into rounded, sinusoidal shaped elements that are highly polished. The elements are connected in a helical pattern to form a fully connected, yet flexible stent device. The smooth edges of the stent also permit delivery without a protective sheath.