Performance

Preshaped Curved Tips stabilize and center the catheter in the junction of the Superior Vena Cava (SVC) and Right Atrium (RA).

Distal Venous and Arterial Side Holes reduce intraluminal pressure and the likelihood of the catheter tips sucking up against the vessel wall.

Large Internal Lumen allows for a flow rate up to 450 mL/min.

Centered on Performance

The high performance CentrosFLO® long-term hemodialysis catheter from Merit Medical was designed with performance, safety, and ease of use in mind. The new SELF-CENTERING, curved-tip catheter has a greater separation between the arterial and venous tips. Its design is intended to optimize CATHETER PATENCY, and reduce fibrin sheath formation, thrombosis and vessel wall occlusions by keeping the tips of the catheter centered in the vessel and away from the vessel wall. Fibrin sheaths are a frequent cause of catheter malfunction and in a study of removed or exchanged hemodialysis catheters, 76% had fibrin sheaths.1,2,3 The CentrosFLO was designed for PERFORMANCE, SAFETY AND EASE OF USE.

Safety

Atraumatic Catheter Tip Design minimizes puncture or irritation of vessel walls.

Non-Traumatic Tunneler for more rapid loading of the catheter without risk to catheter tips.

Multiple Catheter Length Configurations accommodate variations in patient anatomy.

Ease of Use

Peelaway Sheath and Dilator insertion for initial placement.

Stiffening Stylet for over-the-wire placement and exchange.

Polyurethane Material provides ease of insertion and maintenance.

Study Results

A recent retrospective study conducted by Dr. Sarvan Balamuthusamy compared the performance of the self-centering split-tip hemodialysis tunneled catheter and the symmetric tip catheter. The results indicated that the self-centering split-tip catheter had statistically greater patency after 3 months with a slight advantage in clearance and blood flow.4

INDICATIONS FOR USE:

• The Centros® and CentrosFLO™ chronic hemodialysis catheter are indicated for use in attaining long-term vascular access for hemodialysis and apheresis.

• Catheter may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.

• This catheter is indicated for > 30 days (long term) placement.

• Catheter should be removed in accordance with Center for Disease Control (CDC) and Kidney Disease Outcomes Quality Initiative (K-DOQI) guidelines.

CONTRAINDICATIONS:

• This catheter is intended for long-term vascular access only and should NOT be used for any purpose other than indicated in these instructions.

• This catheter is not intended for pediatric use.

• The valved peelable introducer sheath is NOT designed for use in the arterial system or as a hemostatic device.

WARNINGS:

• In the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.

• Do not advance the guidewire or catheter if unusual resistance is encountered.

• Do not insert or withdraw the guidewire forcibly from any component. The wire may break or unravel. If the guidewire becomes damaged, the introducer needle (or sheath introducer) and guidewire must be removed together.

• Use of excessive force on the catheter may cause the suture wing to detach from the bifurcate.

• In the event that a clamp breaks, replace the catheter at the earliest opportunity.

• This catheter is for single patient use only.

• Do not resterilize the catheter or accessories by any method.

• Do not reuse, reprocess or resterilize.

• Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.

• Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.

• Contamination of the device may lead to injury, illness or death of the patient.

• Contents sterile and non-pyrogenic in unopened, undamaged package.

• Do not use catheter or accessories if package is damaged.

• Do not use catheter or accessories if any sign of product damage is visible.

 Before attempting the insertion of the catheter, the physician should be familiar with the following complications and their emergency treatment should they occur:

• Air Embolus

• Allergic Reactions

• Bacteremia

• Bleeding at the site

• Brachial Plexus Injury

• Cardiac Arrhythmia

• Cardiac Tamponade

• Catheter damage due to compression between clavicle and first rib

• Catheter Embolism

• Catheter Occlusion

• Catheter or cuff erosion through the skin

• Central Venous Thrombosis

• Endocarditis

• Exit Site Infection

• Exit Site Necrosis

• Exsanguination

• Extravasation

• Fibrin sheath formation

• Hemothorax

• Hematoma

• Hemorrhage

• Inflammation

• Necrosis or scarring of skin over the implant area

• Laceration of the Vessel

• Lumen Thrombosis

• Mediastinal Injury

• Perforation of the Vessel

• Pleural Injury

• Pneumothorax

• Pulmonary Emboli

• Retroperitoneal Bleed

• Right Atrial Puncture

• Risks normally associated with local and general anesthesia, surgery, and post-operative recovery

• Septicemia

• Spontaneous Catheter Tip Malposition or Retraction

• Subclavian Artery Puncture

• Subcutaneous Hematoma

• Superior Vena Cava Puncture

• Thoracic Duct Laceration

• Thrombocytopenia

• Thromboembolism

• Tunnel Infection

• Ventricular Thrombosis

• Vessel Erosion

• Vascular Thrombosis