• Valved access port with titanium/POM body covered in soft silicone.

  • ChronoFlex® 4.5Fr - 9Fr Catheter.

  • Nitinol self-expandable distal-end anchor for anastomosing the catheter to a target blood vessel.

  • Long-term vascular access.

  • Percutaneous deployment under ultrasound imaging guidance.

  • Percutaneous access for hemodialysis with 14G/16G needle or IV catheter

  • Flow rates up to 500 ml/min.

  • Removable or replaceable through a procedural sheath.

Overview
Components
Procedure
Deployment

1. An introducer sheath is deployed over a guidewire in the target blood vessel.

2. The Tandem™ catheter is pushed through the sheath with the self-expandable Tandem™ anchor compressed into the sheath.

3. When exiting the sheath, the distal struts of the self-expandable Tandem™ anchor expand into the target vessel.

4. The sheath and the Tandem™ catheter are pulled back together until the expanded distal struts are in apposition with the inner blood vessel wall.

5. The proximal basket of the self-expandable Tandem™ anchor expands outside the blood vessel wall when the sheath is peeled off.

6. After verifying patency of the anastomosis, the guidewire is removed.

7. Finally, the Tandem™ access port is implanted subcutaneously. The Tandem™ catheter is potentially tunneled and trimmed and then connected to the implanted Tandem™ access port.

Ultrasound imaging guidance

Usage

To connect the hemodialysis machine, the subcutaneous Tandem™ access ports can be percutaneously accessed using a short IV catheter or a regular hemodialysis needle.

During hemodialysis, blood flow through the Tandem™ device can be monitored by ultrasound color flow imaging.

Unique Value Proposition

Copyright Dialyfix® 2024

  • Disruptive fistula-free hemodialysis™ technology.

  • Elimination of fistula-related hemodialysis complications.

  • Device and method applicable to homecare hemodialysis.

  • Flexible pricing, reduction of healthcare expenditures.

  • Simple and effective percutaneous deployment.

  • Easy to use for hemodialysis sessions.