Vivaxs® Liva

The first bone anchored long-term vascular access for hemodialysis.

In 2009, Cendres+Métaux received an inquiry from the Inselspital in Berne, the largest university hospital in Switzerland, with regard to a development project. The idea was interesting and our interest was immediately aroused. Together with two different university clinics and the ArtOrg Research Center in Berne, Cendres+Métaux was to develop a bone anchored port for hemodialysis. The difficulty: the Class 3 product was to be implanted transcutaneously behind the ear of the patient. No easy task! Development was intensive and lasted several years, but the result paid off in more ways than one:

  • Improved quality of life for dialysis patients
  • Cost reductions for the health care system
  • Unbelievable wealth of experience and accumulated know-how at Cendres+Métaux

Find out more about a unique medical device which will change the world of dialysis in its own way.

Important Note: VIVAXS® Liva is not yet available on the market for sale. The port is currently being tested in a clinical study "Bone Anchored Port" in different Swiss clinics. For more information click on the tab clinical study.

For physicians and patients

Introduction

What is VIVAXS® Liva and how does it work?

VIVAXS® Liva is an innovative long-term vascular access for hemodialysis. The novelty lies in its fixation to the head. The port is implanted into the skull bone behind the ear and thus allows stable and safe access to the large blood vessels in the neck. VIVAXS® consists of a titanium port, a catheter and a cover. Like every other long-term HD catheter, the catheter ends in the right atrium of the heart. Compared with conventional HD catheters, its path is more direct as it runs under the skin from the port to the jugular vein (vena jugularis interna), then into the subclavial vein (vena subclavia) and ends in the right atrium of the heart.


Background

Why is VIVAXS® Liva implanted in the skull?
The idea of implanting a dialysis port in the skull originates from many years of experience with bone anchored hearing aids, which have a low skin infection rate around the implant. The reason is good blood circulation through the scalp and the fact that very little tissue is present between the bone and the skull on the head. Bacterial infections (so-called soft tissue infections) often occur where thicker tissue layers (muscle or fat tissue) are present under the skin. That is why hemodialysis catheter patients and arteriovenous fistula patients are often confronted with such infections. It usually means the ports can no longer be used for hemodialysis.

Advantages

Like every vascular access, the BAP has its advantages and drawbacks. Find out more about its advantages:

The advantages of the BAP versus catheters include:

  • Access in a tissue zone with good blood circulation and lower risk of infection as expected.
  • Lesser or no involvement of soft tissue (muscle or fat tissue).
  • Self-contained system with replaceable components (better hygiene).
  • Safety barrier between port and catheter tip (reduced risk of catheter infection).
  • Fewer catheter blockages due to straighter catheter (scarcely any turbulence).
  • Better resistance to everyday influences.
  • Simple connection of the system also suitable for home dialysis.

The advantages of the BAP versus AV fistulas include:

  • No repeated painful vessel puncture.
  • Both arms are completely free during dialysis.
  • Also suitable for patients suffering from high blood pressure or cardiac insufficiency.
  • Minimal risk of stenosis.
  • Shorter healing times, i.e. the port can be used quicker.
  • Stable anchorage in the bone allows first dialysis shortly after implantation.

Disadvantages

Like every vascular access, the VIVAXS® Liva has its advantages and drawbacks. Find out more about its drawbacks:

The disadvantages of VIVAXS® versus catheters include:

  • Major surgical intervention.
  • More visible.
  • Longer healing time.
  • Explantation is more elaborate than with catheters, but possible and with renewed hair growth on scalp.

The disadvantages of VIVAXS® versus AV fistulas include:

  • Major surgical intervention.
  • More visible.
  • No natural access to the body, the use of foreign materials is necessary.

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Clinical Study

The clinical study has already started and will be conducted at the clinics in Bern, Solothurn and Biel/Bienne, as a first step.

In this section we will inform you about the progress of the clinical study.
Currently, there are no news to be communicated.

Prof. Dr. med. Dominik E. Uehlinger
Chefarzt extrakorporelle Blutreinigungsverfahren

Tel +41 31 632 31 44
Fax +41 31 632 97 34
E-Mail uehlinger@mph.unibe.ch

Universitätsklinik für Nephrologie, Hypertonie und Klinische Pharmakologie
Inselspital
Freiburgstrasse 15
CH-3010 Bern

Dr. med. Anja Kruse
Chefärztin Nephrologie und Dialyse

Tel +41 32 324 35 55
Fax +4132 324 35 66
Email anja.kruse@szb-chb.ch

Nephrologie und Dialyse
Spitalzentrum Biel
Vogelsang 84
CH-2501 Biel/Bienne


PD Dr. med. Stefan Farese
Chief physician, Director of the Nephrology and Haemodialysis department

Tel +41 32 627 42 11
Fax +41 32 627 42 16

E-Mail stefan.farese@spital.so.ch

Bürgerspital Solothurn
Schöngrünstrasse 42
4500 Solothurn

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