FDA Approves Boston Scientific's Apex(TM) PTCA Dilatatio...( New design provides more options for ...)

New design provides more options for treating patients with complex lesions

NATICK, Mass., Nov. 10 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that it has received approval from the U.S. Food and Drug Administration to market its Apex(TM) PTCA(1) Dilatation Catheter. The Apex Catheter is a high-performance pre-dilatation balloon catheter developed specifically to address physicians' needs in treating the most challenging atherosclerotic lesions. It is available for distribution in both Monorail(R) and Over-The-Wire (OTW) catheter platforms.

The Apex Catheter represents the next generation of dilatation catheter technology, utilizing a new Bi-Segment(TM) inner shaft for improved pushability and flexibility. Additionally, it has a redesigned tip with the same low profile as the Maverick(R) PTCA Dilatation Catheter for excellent turning and wire tracking.

It is available in a wide array of balloon diameters from 1.5mm up to 5.0mm, with balloon lengths ranging from 8mm up to 40mm (for select diameters). Both the Apex Monorail and OTW catheters are available in two different 1.5mm designs -- "Apex Push Catheter" and "Apex Flex Catheter." The Apex Push Catheter is designed to enhance pushability for tight lesions, while the Apex Flex Catheter is designed to enhance trackability for tortuous arteries. The two 1.5mm Apex Catheter designs enable physicians to select the appropriate catheter based on the clinical situation.

"A much greater number of 'complex' lesions could be more readily crossed and dilated if more advanced, next-generation, catheter technology were available," said James Hermiller, M.D., Director of the Interventional Fellowship at St. Vincent Heart Center of Indiana
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