Medtronic Gets FDA Clearance Of Small Vessel Coronary Stent
Medtronic, Inc. announced extension of its Medtronic AVE product line into the important U.S. market for small coronary stents. The Medtronic AVE S540 coronary stent system has been cleared for commercial release by the FDA.
The S540 is implanted by interventional cardiologists to facilitate blood flow in heart arteries whose diameter is approximately that of the lead in a standard pencil. The S540 will be available immediately to U.S. physicians for use in cases of acute or threatened closure during a planned interventional procedure in de novo lesions (less than or equal to 24 mm in length) within a native coronary artery or arterial bypass graft conduit with a reference diameter between 2.2-2.9 mm.
Scott Solano, president and chief executive officer of Medtronic's Vascular business, noted that the S540 stent system has been specifically designed for small coronary arteries, which traditionally have represented approximately 15% of coronary stent procedures. He emphasized that the new device is not simply a downsized version of stents offered by Medtronic AVE in markets for larger 3.0, 3.5, and 4.0 mm. sizes.
"The small-diameter U.S. stent market is increasingly important as cardiologists address serious blockages in a greater portion of the tortuous coronary anatomy," stated Solano. "We believe this to be the broadest approval among similar size devices and we expect cardiologists to quickly recognize the advantages of the new technologies incorporated in the S540. It has come to represent a significant portion of our stent sales in European markets, and we expect it to win rapid acceptance in the United States."
The S540 features an average lesion crossing profile of only .039 in. in diameter -- less than one millimeter-- facilitating delivery across tight lesions. This is the lowest profile of any of Medtronic AVE's stent systems, released to-date in the U.S. The S540 is available in five lengths from eight millimeters. to 24 mm., enabling the cardiologist to match its length to the lesion, thus implanting no more metal in the artery than necessary. Crafted with laser-fusion techniques in a unique manufacturing process, the stent offers a highly flexible edgeless design with excellent radial strength.
The S540 balloon catheter delivery system which provides a wide working range of inflation pressures from eight to 14 atmospheres, employs Medtronic AVE's patented stent securement system.
Commercially released in Europe just over a month ago, the S540 joinsthe S670, the GFX2, the GFX and the Medtronic beStent coronary stent systems as integral components of a complete therapeutic system -- including guiding catheters, steerable guidewires, balloon dilatation catheters andother procedure accessories -- for the treatment of coronary artery disease. The S670 and beStent devices are commercially available only outside the United States.