FDA Clears Boston Scientific System for
Removing Clots from Arteries
NATICK, Mass., May 31, 2006 -- Boston Scientific Corporation (NYSE: BSX) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Rio™ Aspiration Catheter, the latest addition to the Company's line of vascular protection devices for minimally invasive procedures. The new device is indicated for use in the removal of thrombi, or clots, from vessels throughout the body.
Clots can restrict or block blood flow in an artery, creating difficulty or risk to a patient when undergoing intravascular procedures. The Rio Aspiration Catheter can be used with other interventional devices, such as those used to place stents, to open blockages caused by clots in the target area within a vessel.
"The Rio Aspiration Catheter provides physicians with a simple, dependable and versatile means of restoring blood flow and improving visibility during intravascular interventions," said Hank Kucheman, President of Boston Scientific's Interventional Cardiology business. "We are pleased to offer physicians another treatment option in our portfolio of vascular protection devices."
The Rio Aspiration Catheter is comprised of two tubular cavities, or lumens. The primary lumen is used to extract the thrombus. It is open on one end and attached via an extension tube to a 20-cc locking syringe on the other. The syringe is used to apply suction and aspirate the thrombus from the vessel. The second lumen accommodates a guide wire, which is used to move the catheter into position within the target artery. The Rio Aspiration Catheter is compatible with large lumen 6F guide catheters (minimum inner diameter of 0.070 in.). The catheter shaft, which becomes more flexible toward the tip, is designed to help reduce trauma to the vessel and facilitate navigation through tortuous anatomies. A radiopaque marker on the tip further assists in successful maneuvering and placement of the device.
The Rio Aspiration Catheter joins Boston Scientific's FilterWire EZ™ Embolic Protection System -- which traps fragments that are released during a procedure -- to offer physicians another vascular protection treatment option.
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: http://www.bostonscientific.com/.
This press release contains forward-looking statements. Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
CONTACT:
Milan Kofol
508-650-8569
Investor Relations
Boston Scientific Corporation
Paul Donovan
508-650-8541
Media Relations
Boston Scientific Corporation
Source: Boston Scientific Corporation |
