St. Jude Gets CE Mark, Launches HydroSteer Guidewire with Hydrophilic Coating in Europe


July 11, 2008

July 11, 2008 - St. Jude Medical Inc. today received European CE Mark approval and began its European launch of its line of HydroSteer 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.

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, the company said a torque device enhances steerability by aiding directional control. The torque device also has received CE Mark approval and is available for separate purchase, the company said.

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