The CorInnova Implantable Cardiac Assist System for Direct Cardiac Compression.

Area of Science:

• Biomedical Engineering
• Cardiovascular Research
• Medical Devices

Background:

• Heart failure presents limited mechanical circulatory support options, particularly for specific patient groups.
• Existing devices often involve blood contact and require anticoagulation, posing risks for certain individuals.
• There is a need for innovative, safe, and effective cardiac support solutions for underserved heart failure populations.

Purpose of the Study:

• To introduce the CorInnova cardiac compression device, a novel approach to biventricular support.
• To describe the device's design, mechanism of action, and potential benefits for heart failure patients.
• To highlight the device's unique features, including blood-contact-free operation and suitability for anticoagulation-intolerant patients.

Main Methods:

• The CorInnova device features concentric polyurethane chambers (inner saline-filled, outer air-filled) and a Nitinol frame.
• The inner chambers conform to the epicardial surface, while outer chambers provide synchronized compression and negative pressure.
• Minimally invasive self-deployment and easy removal are key design aspects.
• Preclinical testing in animal heart failure models was conducted.

Main Results:

• Preclinical testing demonstrated promising improvements in cardiac output and other cardiac parameters in heart failure models.
• The device design facilitates intimate contact with the heart and enhances diastolic filling.
• The device operates without blood contact, eliminating the need for anticoagulation.

Conclusions:

• The CorInnova device represents a potentially transformative technology for heart failure management.
• It offers effective biventricular support and ventricular unloading, addressing limitations of current options.
• This device may be particularly beneficial for patients with biventricular failure, right heart failure, or contraindications to anticoagulation.