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altratouch 1000 hemodialysis delivery system
Althin Medical Ab An Affiliate Of Baxter Intl
Summary: The Altratouch 1000 is a hemodialysis delivery system used for renal replacement therapy in patients with end-stage kidney disease. Key evidence highlights its role in managing chronic dialysis and associated vascular access challenges.
FDA Clearance Information
Pathway
510K
Number
K954987 ↗
Decision Date
August 8, 1996
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The Altratouch 1000 Hemodialysis Delivery System was cleared by the FDA via the 510(k) pathway on August 8, 1996. It is manufactured by Althin Medical Ab, an affiliate of Baxter Intl, and is classified as a Class 2 device.
What It Is
The Altratouch 1000 is a hemodialysis delivery system designed to perform dialysis by removing waste products and excess fluid from the blood when the kidneys are no longer able to do so. It is intended for use in clinical settings for patients with end-stage renal disease.
Clinical Applications
This device is commonly used in dialysis centers and hospitals for patients requiring chronic hemodialysis. It is particularly relevant for managing patients with end-stage kidney disease who need regular dialysis sessions to maintain their health.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs, prospective, and retrospective studies, published between 2006 and 2024. These studies explore different aspects of dialysis management and outcomes.
Reported Outcomes
Published studies report that the Altratouch 1000 is effective in managing chronic dialysis, with particular emphasis on its role in maintaining vascular access via arteriovenous fistulas. Outcomes include successful dialysis sessions and management of renal function during pregnancy.
Safety Profile
Reported complications include issues related to vascular access, such as neointimal hyperplasia in arteriovenous fistulas, which can lead to access failure. Other safety concerns are related to the general risks of hemodialysis, such as infection and cardiovascular stress.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials specifically evaluating the Altratouch 1000. Further research is needed to explore long-term outcomes and device-specific complications.
Frequently Asked Questions
What are the clinical indications for Altratouch 1000 Hemodialysis Delivery System?
The device is indicated for use in patients with end-stage renal disease requiring chronic hemodialysis.
What outcomes have been reported in clinical studies?
Studies report effective management of chronic dialysis and maintenance of vascular access, with successful dialysis sessions and renal function management during pregnancy.
What complications have been reported?
Safety data indicate complications such as neointimal hyperplasia in arteriovenous fistulas, infection risks, and cardiovascular stress associated with hemodialysis.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.