K Pump-Mackenzie: Technological Development and Initial Bench Validation of a Fully Implantable 5G-Enabled Ventricular Assist Device.

Authors

Luiz Fernando Kubrusly, Osvaldo Malafaia, Benedito Guimarães Aguiar Neto, Paulo Batista Lopes, Roberto Coutinho, Cristiano Akamine, Pollyana Coelho da Silva Notargiacomo, Giovanna Santana, Cleide Lustosa de Oliveira da Silva, Elesandro Antonio Baptista, Licia M D'arezzo Maestrelli, Douglas Mesadri Gewehr, Cris Rangel de Abreu, Fernando Bermudez Kubrusly

Published in

Brazilian journal of cardiovascular surgery. Volume 41. Issue 3. May 01, 2026.

Abstract

Advanced heart failure is an important cause of mortality in Brazil. Limited access to heart transplantation and the high cost of imported devices reinforce the need for national technological solutions. The K Pump-Mackenzie project proposes the development of a fully implantable mechanical circulatory assist device, integrated with 5G telemetry, with potential application in the unified health system of Brazil, the Sistema Único de Saúde.
A centrifugal prototype rotor, with real-time control system and integrated flow and pressure sensors, was developed. The device was submitted to laboratory tests to evaluate mechanical performance, operational stability, structural integrity, and connectivity via 5G network. The preclinical protocol in the sheep model was designed and approved by the Comissão de Ética no Uso de Animais, from the Faculdade Evangélica Mackezie do Paraná, in accordance with Conselho Nacional de Segurança Alimentar e Nutricional guidelines.
In bench tests, the device showed controlled rotation of up to 10,000 rpm, adjustable flow between 2 and 6 L/min, and average latency of < 20 ms in data transmission. Continuous operational stability was observed for up to 72 hours, with adequate functioning of the monitoring and safety systems.
K Pump-Mackenzie demonstrated technical feasibility and satisfactory performance in initial bench validation. The planned preclinical stage will be fundamental to evaluate safety and biological performance, constituting a necessary step for future clinical application, and will take place in 2026.

PMID:
42853151
Bibliographic data and abstract were imported from PubMed on 09 Oct 2026.

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