July 10, 2008
St. Jude Medical Announces CE Mark Approval and European Launch of HydroSteer Guidewire Line With Hydrophilic Coating
St. Jude Medical, Inc. (NYSE:STJ) today announced European CE Mark approval and European launch of its line of HydroSteer(TM) Hydrophilic-Coated Nitinol Guidewires.
The HydroSteer line of guidewires features a lubricious hydrophilic coating which becomes slippery when wet, thereby reducing friction and enabling physicians to more easily maneuver the wires through the patient's vessels. The HydroSteer line includes a wide variety of sizes, lengths and configurations.
The HydroSteer family is designed to provide physicians with more control of the guidewire's tip, allowing the physician optimal placement of the subsequent procedural tools. Each wire in the HydroSteer line provides excellent steerability to help physicians navigate challenging vascular structures.
Guidewires are used to gain access in a variety of cardiovascular procedures; for example, a guidewire can allow a physician access to the area where a patient's artery or vein may be blocked or narrowed. A guidewire is a thin, flexible wire that physicians use to help guide and steer a catheter (a flexible tube) through the vessels to deliver treatments, such as stents, which open blockages and restore blood flow to the heart or other parts of the body.
A radiopaque polymer jacket on the wire's Nitinol (nickel-titanium alloy) core enhances the physician's ability to visualize the wire's location in the vessel. The wire's Nitinol core resists kinking while providing the flexibility physicians need to advance the wire through the vasculature. In addition, a torque device enhances steerability by aiding directional control. The torque device also has received CE Mark approval and is available for separate purchase.
"With the introduction of HydroSteer, the recent launch of the TigerWire(TM) Guidewire and the availability of our existing GuideRight(TM) Guidewire line, physicians now may choose from a full complement of St. Jude Medical guidewires used in interventional and diagnostic procedures," said Denis Gestin, president of the St. Jude Medical International Division. "These products reflect our commitment to providing physicians with medical devices that help them control risks and attain the best patient outcomes."
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 12,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit www.sjm.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K filed on February 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.