WorldHeart’s 4th-generation LevacorTM VAD is the only bearingless, fully magnetically levitated implantable centrifugal rotary pump to have seen clinical use.

The Levacor VAD’s evolution is described from concept to proof of technology feasibility to a product, one of the most sophisticated medical devices ever, leading to its demonstration of clinical feasibility. In parallel, the organizational evolution from within an academic laboratory to a private, development-stage start-up to a public, commercially focused company is outlined.

The proprietary, enabling technologies for this device, including MagLevTM technology, were conceived in the early 1990s, in part by the University of Utah’s Artificial Heart Research Laboratory and by a Utah-based start-up company, MedQuest Products, Inc.

Technology feasibility of the concept was demonstrated with engineering prototypes that evolved for uses that ranged from bench testing to acute ex vivo experiments. A clinically relevant blood pump architecture was selected for final development in the early 2000s. Extensive system development and testing was conducted in parallel with the critical growth of manufacturing and quality systems.

A clinical product with electronics configured for portability was defined, developed and validated with life tests and chronic in vivo tests. This system was successfully deployed in initial human clinical feasibility trials in Greece in 2006 in two patients. By that time, privately-held MedQuest had been acquired by publicly-held World Heart Corporation.

WorldHeart’s current focus is on activities leading to the start of a U.S. clinical trial with a wearable and user-friendly electronics configuration to allow the evaluation of the Levacor VAD’s long-term implantability, durability, biocompatibility and quality of life.

This is an important step towards eventual approval as a potential therapy for the treatment of several hundreds of thousands of adults worldwide with late-stage congestive heart failure.

The technology is being adapted for two additional blood pump products: a smaller MiVADTM designed to provide a lower degree of support for less-sick heart failure patients, and the PediaflowTM VAD for neonates born with congenital heart defects who need corrective surgery.