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The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Console is intended for use with the stylet supplied by VasoNova. The Vascular Positioning System consists of a Console and associated power supply and cabling and a stylet. The VPS Console, when used with the VPS Stylet, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the Vascular Positioning System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location. The Vascular Positioning System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. NOTE: If a steady blue bull's eye is not obtained, standard hospital practice should be followed to confirm catheter tip location. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The VPS System consists of a VPS Console with tablet display and a VPS Stylet. The VPS G4 Console consists of two key integrated software-driven components: a data acquisition module and an embedded computer with processing capabilities. The data acquisition module within the console transmits and receives ultrasound data while receiving electrical signals from the heart through sensors mounted at the tip of the VPS Stylet. Using signals gathered by the data acquisition module, the graphical user interface provides the user with guidance for tip positioning of central venous access devices. The separately provided VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end of the stylet connects to an extension cable that connects to the VPS Console.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a blue bullseye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The VPS System consists of a VPS Console and VPS Stylet. The VPS Console consists of two key integrated software-driven components: a data acquisition module; and a PC with processing and display capabilities. The VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet can be inserted and removed from any catheter with a luminal diameter of at least 0.021 inches. The data acquisition module of the console transmits and receives ultrasound data while receiving electrical signals from the heart through sensors mounted at the tip of the VSP Stylet. Using signals gathered by the data acquisition module, the graphical user interface of the PC provides the user with guidance for tip positioning.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Console is intended for use with the stylet supplied by VasoNova. The VPS System consists of a Console and associated power supply and cabling and a stylet. The VPS Console, when used with the VPS Stylet, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a blue bull's-eye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

The VPS System consists of a VPS Console and VPS Stylet. The VPS Console consists of two key integrated software-driven components: a data acquisition module; and a PC with processing and display capabilities. The data acquisition module of the console transmits and receives ultrasound data while receiving electrical signals from the heart through sensors mounted at the tip of the VPS Stylet. Using signals gathered by the data acquisition module, the graphical user interface of the PC provides the user with guidance for tip positioning. The VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet can be inserted and removed from any catheter with a luminal diameter of at least 0.021 inches.

VPS Catheters are indicated for short or long-term central access to the central venous system for intravenous therapy, central venous pressure monitoring and contrast studies. For blood or hyperalimentation delivery, use a 4F or larger catheter. The maximum recommended injection rate is 2cc/sec for the 3F catheter and 5cc/sec for the 4F and 5F catheters. Each VPS Catheter is indicated for use by itself or with the VPS System (Stylet and Console).

The VPS Catheter is designed for use with or without the VPS Console. When sold together, the VPS Catheter is preloaded with the Stylet and supplied in a tray. The VPS Catheter is sterile, single use, non-pyrogenic and non-toxic. VPS Catheters are single lumen (3F and 4F) or dual lumen (5F) open-ended central venous access catheters fabricated from a soft, radiopaque, biocompatible polyurethane material with a working length of 50 or 55 cm and catheter markings at 1 cm intervals and 5 cm increments. VPS Catheters are packaged sterile with the VPS Stylet in a tray with accessories necessary for a percutaneous micro-introducer placement (Modified Seldinger or Seldinger technique). The VPS Catheters feature a reverse-taper design.

VPS Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy and injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended injection rate is 2cc/sec for the 3F catheter and 5cc/sec for the 4F and 5F catheters. The VPS Catheter is indicated for use by itself or with the VPS System (Stylet and Console) sold separately.

The VPS Catheter and VPS Stylet are designed for use together and with the VPS Console. The VPS Catheter is preloaded with the Stylet and supplied in a tray. The VPS Catheter/Stylet is sterile, single use, non-pyrogenic and non-toxic. The VPS Catheters are single lumen (3 and 4 Fr) or dual lumen (5 Fr) central venous access catheters made from soft, radiopaque medical grade polyurethane and packaged with the VPS Stylet in a tray with the accessories necessary for a percutaneous microintroducer placement (Modified Seldinger or Seldinger technique). The VPS Catheters feature a reverse-taper open ended design with a working length of 50 or 55 cm. VPS Catheters are marked at 1 cm intervals and labeled every 5 cm for the entire length. The VPS Stylet is a 6 foot long polymeric tube which contains a Doppler sensor at the distal tip and an intravascular electrocardiogram (ivECG) signal sensing wire. The Doppler sensor and the ivECG signal sensing wire, when connected to the VPS Stylet are used to detect and transmit physiological information to the VPS Console (available separately). The VPS Stylet has an outer diameter of 0.019 inches and is designed to be used with the compatible VPS Catheter with an inner lumen of 0.021 inches.

The FlowPICC Catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy and injection of contrast media. For blood sampling, infusions, or therapies, use a 5F or larger catheter. The maximum recommended infusion rate is 5cc/sec. The FlowPICC Catheter is indicated for use by itself or with the FlowPICC System (Stylet and Console) sold separately.

The FlowPICC Catheter is a double lumen open-ended PICC designed for power injection through one designated lumen. The FlowPICC Catheter is fabricated from a soft, radiopaque, biocompatible polyurethane material with a working length of 50 cm with markings in 5 cm increments. The catheter is packaged with accessories necessary for implantation of a PICC catheter using a Seldinger or modified Seldinger technique. A stylet and adaptor sidenort are provided to assist in catheter insertion.

The FlowPICC System is indicated for use as a supplemental aid in PICC placement in patients requiring a PICC catheter. The FlowPICC™ Console when connected to the FlowPICC Stylet is intended for use with commercially available PICC catheters with a minimum luminal diameter of 0.021" for assistance in tip placement of the PICC catheter in the patient's vasculature. The FlowPICC System provides real-time catheter tip location information by using the patient's physiological information.

The FlowPICC™ System consists of a Console and a Stylet and is designed to be used with any commercially available PICC (peripherally inserted central catheter) with a minimum luminal.diameter of 0.021 inches. The FlowPICC Console integrates a data acquisition system, two DAQ cards, an isolation transformer and a PC pre-loaded with proprietary software. The Console, when used as intended, uses a blood velocity profile and heart electrical activity to provide user feedback and guiding indicators for proper PICC catheter tip placement in the caval-atrial junction. The Console provides two user display selections: normal and simplified. With either display, guiding indicators will notify when the catheter is moving towards the heard, moving away from the heart, in the proper location or should be adjusted because there isn't enough information.

The FlowPICC System, consisting of a Stylet and a Console, is indicated for use as a supplemental aid in PICC placement in patients requiring a PICC catheter. The FlowPICC™ Console when connected to the FlowPICC Stylet is intended for use with commercially available PICC catheters with minimum luminal diameter of 0.021'' for assistance in tip placement of the PICC catheter in the patient's vasculature. The FlowPICC System provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording, and intravascular ultrasound for catheter guiding and positioning.

The FlowPICCTM System consists of a Console and a Stylet and is designed to be used with any commercially available PICC (peripherally inserted central catheter) with a minimum luminal diameter of 0.021 inches. The FlowPICC Stylet is a polymeric tube which contains a Doppler sensor and in intravascular electrocardiogram (ivECG) signal sensing wire. The Doppler sensor and the exposed portion of the ivECG signal sensing wire are located at the flowPICC Stylet. The FlowPICC Stylet is 6 feet long and has an outer diameter of 0.019". The tip of the FlowPICC Stylet is positioned within a compatible catheter (luminal diameter 0.021") and maintained there throughout the PICC placement procedure. The proximal end has two connectors provide the connectivity to the FlowPICC Console.