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FDA Approves Boston Scientific's Apex™ PTCA Dilatation Catheter

FDA Approves Boston Scientific's Apex™ PTCA Dilatation Catheter

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™ 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® and Over-The-Wire (OTW) catheter platforms.

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 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 in Indianapolis. "I
believe the Apex Catheter represents a next generation of catheter

"The Apex Catheter is a reflection of Boston Scientific's commitment to
providing physicians with the most complete set of high-performance
cardiovascular devices possible," said Hank Kucheman, Senior Vice President
and Group President, Cardiovascular. "As an established market leader, we
listened to physicians' requests for improvements to existing balloon
catheters, and responded with the advanced technology found in the Apex

The Apex Catheter builds on Boston Scientific's reputation for developing
market-leading balloon catheters. Boston Scientific makes the number one
selling pre- and post-dilatation catheters (Maverick® and Quantum™
Maverick®) in the U.S. market today.

The Apex Catheter is the latest technological development by Boston
Scientific intended to improve the management of patients with coronary
atherosclerosis undergoing percutaneous coronary intervention (PCI). Boston
Scientific furthers PCI optimization through a broad range of devices,
including ultrasound imaging to assess lesions and balloon catheters and
drug-eluting stents to reopen blocked arteries. This broad portfolio of
devices supports physicians' efforts to achieve safe and effective outcomes
for their patients.

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 United States, accounting for
more than 870,000 deaths each year.(2)

Boston Scientific is a worldwide developer, manufacturer and marketer of
medical devices whose products are used in a broad range of interventional
medical specialties. For more information, please visit:

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