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K Pump-Mackenzie: Technological Development and Initial Bench Validation of a Fully Implantable 5G-Enabled
Luiz Fernando Kubrusly1, Osvaldo Malafaia1, Benedito Guimarães Aguiar Neto2
1Faculdade Evangélica Mackenzie do Paraná Curitiba Paraná Brazil Programa de Pós-Graduação em Princípios da Cirurgia, Faculdade Evangélica Mackenzie do Paraná, Curitiba, Paraná, Brazil.
Introduction:
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.
Methods:
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.
Results:
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.
Conclusion:
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.
