Ten-year NEDO BVAD development program: moving forward to the clinical arena.
Since 1995, the Baylor Group has been developing a totally implantable NEDO BVAD system. This 10-year program was completed in March 2005, and preparation for clinical trials is underway. This article summarizes the entire 10-year NEDO program and describes the strategy for clinical trials. The project aimed to achieve: (1) dual centrifugal pumps with the ability of full biventricular support, (2) a compact system implantable into small adults, (3) a totally implantable system with transcutaneous energy transmission system (TETS), (4) a durable system with a lifetime of over 5 years, and (5) a system free of thrombus and with minimal hemolysis. The final goals are to complete preclinical system evaluations and commence the clinical trials in the near future. In vitro studies have demonstrated a pump capacity of over 8.5 l/min and an Index of Hemolysis of <0.004 g/100 l. The pump-bearing life expectancy was over 5 years. To date, eight pumps endured in vivo studies of over 3 months without complications, including thromboembolic events. The in vitro endurance studies of eight pumps are longer than 1 year. There were no mechanical malfunctions or pump failure. A stepwise clinical trial is being planned: Step1, a wearable BVAD/VAD will be clinically studied; Step 2, the BVAD/VAD will be implanted intracorporeally without TETS; and, Step 3, a totally implantable system will be clinically evaluated. The NEDO BVAD system has completed preclinical testing. Clinical trial preparation is underway.
Motomura
Tadashi
T
Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas, Japan.
Okubo
Hisashi
H
Oda
Takeshi
T
Ogawa
Daisuke
D
Okahisa
Toshiya
T
Igo
Stephen
S
Shinohara
Toshiyuki
T
Yamamoto
Yoshiro
Y
Noguchi
Chikaya
C
Ishizuka
Tsukasa
T
Okamoto
Eiji
E
Nosé
Yukihiko
Y
D000818:Animals; D001243:Assisted Circulation / Q000295:instrumentation*; D001672:Biocompatible Materials; D001698:Biomedical Engineering; D002417:Cattle; D002498:Centrifugation; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D006354:Heart, Artificial; D006353:Heart-Assist Devices; D006461:Hemolysis; D006801:Humans; D008422:Materials Testing; D008904:Miniaturization; D008955:Models, Cardiovascular; D011474:Prosthesis Design; D019919:Prosthesis Implantation; D013499:Surface Properties; D014025:Titanium
D001672:Biocompatible Materials; D014025:Titanium