In vivo performance evaluation of the Innovamedica pneumatic ventricular assist device

Area of Science:

• Biomedical Engineering
• Cardiovascular Devices
• Medical Technology Evaluation

Background:

• Circulatory support programs require effective and reliable devices.
• Existing ventricular assist devices (VADs) can be complex and costly.
• A simple, low-cost VAD prototype is needed for wider hospital adoption.

Purpose of the Study:

• To evaluate the in vivo performance of the Innovamedica pneumatic ventricular assist device (VAD).
• To assess the hemodynamic performance, hematological impact, and biocompatibility of the VAD prototype.
• To determine the feasibility of the VAD for short-term and extended (30-day) left ventricular support.

Main Methods:

• Implantation of the Innovamedica VAD in 6 sheep for short-term (6-hour) hemodynamic monitoring.
• Left ventricular support implantation in 2 sheep for a 30-day evaluation period.
• Monitoring of hemodynamic parameters, hematological variables, plasma free hemoglobin (hemolysis), and post-mortem tissue assessment.

Main Results:

• Short-term VAD support maintained mean blood flow of 4.4 L/min and mean arterial blood pressure of 76 mmHg.
• Plasma free hemoglobin levels showed minimal increase, indicating low hemolysis (5.11 mg/dl short-term, 5.9 mg/dl long-term).
• The VAD operated reliably for 30 days with no significant adverse events, blood clots, or tissue damage; it was easy to implant and de-air.

Conclusions:

• The Innovamedica pneumatic VAD is effective and reliable for providing circulatory support.
• The device demonstrates good biocompatibility with minimal hemolysis and no significant organ damage.
• This low-cost VAD prototype is a promising option for hospital circulatory support programs.