Intran® Plus Intrauterine Pressure Catheters

Intran® Plus is the original transducer-tipped intrauterine pressure catheter (IUPC) preferred by thousands of clinicians for its unrivaled accuracy, safety and reliability.

The sensitive, single-use pressure transducer of Intran® Plus is located at the tip of the catheter that is placed inside the uterus. Placement of the transducer inside the uterus ensures that clinical decisions are based on the most accurate contraction frequency, duration, resting tone and peak pressure data.

The transducer of Intran® Plus is encapsulated in a soft, blunt boot which prevents partial obstruction by maternal or fetal tissue from affecting the pressure tracing. Coupled with the proprietary SensaFlex™ tubing material of Intran® Plus, the blunt tip allows clinicians to sense and avoid tissue obstructions prior to causing injury. Since its release in 1991, over 5 million Intran® Plus IUPC's have been used without a single reported serious injury.*

The Unique Design of Intran® Plus:

• INSERTION TACTILITY & SAFETY: Intran® Plus is designed with SensaFlex™, a tactile tubing material that is stiff enough to allow insertion while maintaining the pliability necessary to avoid injuries. Combined with the soft, blunt tip of Intran® Plus, SensaFlex™ tubing allows the clinician to sense tissue obstructions prior to causing injury.
• TIP SIZE AND SHAPE: Intran® Plus is available in small and regular catheter tip sizes. The small tip (.19" H x .25" W x .90" L) may be slightly easier to introduce through tightly stretched cervical tissues. The regular tip (.25" H x .30" W x 1" L) is also inserted easily but is the optimal size, shape and softness to facilitate safe placement and avoidance of patient tissue injury.
• DUAL LUMEN DESIGN & AMNIOINFUSION: The dual lumen design of Intran® Plus allows simultaneous monitoring of uterine contractions and baseline readings while amnioinfusing.
• AMNIOTIC FLUID VISUALIZATION: All Intran® Plus configurations are designed with a clear covering over the lumen used for amnioinfusion (Amniolumen). Clinicians may use the clear Amniolumen to assess amniotic fluid return upon IUPC placement or for visualization of fluid during the course of labor. The Amnio View Port option provides a convenient means of amniotic fluid visualization and includes a meconium color scale to facilitate observation of changes in meconium color over time.
• RE-ZERO CAPABILITIES: The Intran® Plus IUPC system typically requires a single monitor zeroing procedure. However, a convenient method for re-zeroing the system is provided through the availability of a re-zero switch on the catheter or button on the re-usable cable.
• LATEX-FREE: Intran® Plus contains no latex or latex by-products.

* The FDA Manufacturer And User Device Experience (MAUDE) database represents reports of adverse events involving medical devices. The online search allows viewing of CDRH (Center for Devices and Radiological Health) database information about medical devices which may have malfunctioned or caused a death or serious injury.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm