projects

CHIARA

Congestive Heart Impairment Advanced Removal Approach

CHIARA

Congestive Heart Impairment Advanced Removal Approach

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Ownership

Project

CHIARA (Congestive Heart Impairment Advanced Removal Approach) is a medical device that fulfills a critical need in the medical field for Slow Continuous Ultrafiltration (SCUF) in patients weighting over 20 kg (44,0925 lbs.) and suffering from congestive heart failure or fluid overload.

This device can be used in emergency departments and in-outpatient care, avoiding patient admission to ICU.

This solution was demonstrated at the Teoresi Group booth at MEDICA 2023.

Client

Businesses in the medical sector, healthcare companies/hospitals.

Industries

Life Sciences

Scenario

Cardiovascular medicine is a rapidly evolving field with ongoing research and innovation aimed at advancing our understanding of cardiovascular diseases, improving diagnostic techniques and treatment modalities, and enhancing patient outcomes. Progress of healthcare technologies and development of advanced filtration devices such as CHIARA leads to less evasive and more efficient treatment for patients with cardiac failure and fluid overload.

Challenges

The main challenges faced in the design and implementation of this product are:

Technical Validation: Ensuring that the technology behind CHIARA, particularly its ultrafiltration mechanism and minimally invasive approach, underwent rigorous testing to validate its effectiveness and safety.

Regulatory Compliance: Meeting the stringent regulatory requirements for medical devices, including certification processes, to ensure CHIARA’s compliance with industry standards and regulations.
Clinical Trials: Conducting comprehensive clinical trials to assess the performance, safety, and efficacy of CHIARA in real-world patient scenarios, while adhering to ethical guidelines and patient safety protocols.
Integration with Existing Systems: Ensuring seamless integration of CHIARA with existing healthcare infrastructure, such as hospital protocols, patient monitoring systems, and medical staff training, to facilitate its adoption and use within healthcare facilities.
Supply Chain Management: Managing the supply chain for CHIARA’s components and materials, including sourcing high-quality components, ensuring reliable in-house manufacturing processes, and maintaining adequate inventory levels to meet demand.

Our added Values

Expertise in industrial research, biomedical engineering, and profound understanding of high-tech healthcare technologies facilitated the comprehensive development of CHIARA, from an initial concept to a fully functional medical device ready for market deployment.

The innovative conceptualization of CHIARA’s development demonstrates the core of Teoresi MedTech’s (previously Medicon Ingegneria) approach. Through astute market analysis and an innate ability to identify unmet needs, Teoresi MedTech excels in crafting solutions tailored to address evolving demands and is dedicated to advancing healthcare through transformative solutions.

Furthermore, commitment to regulatory compliance underscores Teoresi MedTech’s adherence to industry best practices and its focus on product safety and legality.

Results

CHIARA is distributed on the global market and available at many healthcare structures, hospitals, and clinics. Specifically, the main results achieved through its applications are:

The reduction of hospitalization and readmission rate can consequently reduce the costs for healthcare facilities.
Balanced the need for advanced technology and quality with cost considerations to ensure CHIARA remains affordable and accessible to healthcare providers and patients alike.
Iteratively refined CHIARA’s design and functionality based on user feedback from clinicians, healthcare providers, and patients to enhance its usability, comfort, and overall user experience.

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