Ten-year NEDO BVAD development program: moving forward to the clinical arena

Area of Science:

• Biomedical Engineering
• Cardiovascular Devices

Background:

• The Baylor Group has developed a totally implantable NEDO biventricular assist device (BVAD) system over a 10-year period.
• Preparation for clinical trials is underway following the program's completion in March 2005.

Purpose of the Study:

• To summarize the 10-year NEDO program and outline the strategy for clinical trials.
• To achieve dual centrifugal pumps for full biventricular support, a compact system for small adults, a totally implantable system with transcutaneous energy transmission, and a durable system (over 5 years) free of thrombus with minimal hemolysis.

Main Methods:

• The study involved extensive in vitro and in vivo testing of the NEDO BVAD system.
• Preclinical evaluations included pump capacity, Index of Hemolysis, pump-bearing life expectancy, and endurance studies.

Main Results:

• In vitro studies demonstrated a pump capacity exceeding 8.5 l/min and an Index of Hemolysis below 0.004 g/100 l.
• In vivo studies showed eight pumps enduring over 3 months without complications, including thromboembolic events.
• In vitro endurance studies exceeded 1 year for eight pumps, with no mechanical malfunctions or failures.

Conclusions:

• The NEDO BVAD system has successfully completed preclinical testing, meeting key performance and durability goals.
• A stepwise clinical trial plan is established, progressing from wearable devices to fully implantable systems.
• The system is poised for clinical evaluation, aiming to provide a durable and effective solution for biventricular support.