FDA Clears Boston Scientific's Apex PTCA Dilatation Catheter
November 10, 2008 - Boston Scientific Corp. today said it received FDA approval to market its Apex PTCA Dilatation Catheter, a high-performance pre-dilatation balloon catheter developed specifically to address physicians' needs in treating the most challenging atherosclerotic lesions.
The catheter is available for distribution in both Monorail and Over-The-Wire (OTW) catheter platforms.
Boston said the Apex Catheter represents the next generation of dilatation catheter technology, utilizing a new bi-segment inner shaft for improved pushability and flexibility. Additionally, it has a redesigned tip with the same low profile as the Maverick PTCA Dilatation Catheter for excellent turning and wire tracking.
It is available in a wide array of balloon diameters from 1.5mm up to 5mm, with balloon lengths ranging from 8mm up to 40mm. 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 is designed to enhance pushability for tight lesions, while the Apex Flex is designed to enhance trackability for tortuous arteries.
"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 in Indianapolis. "I believe the Apex Catheter represents a next generation of catheter technology."
PTCA dilatation catheters are used in coronary angioplasty and stenting procedures to open arteries blocked by atherosclerosis, which if left untreated can cause heart attack and stroke. Coronary artery disease represents the leading cause of death in the U.S., accounting for more than 870,000 deaths each year.
For more information: www.bostonscientific.com