WorldHeart has roots in heart-assist device technologies that span more than three decades and combines (3) companies:
In 1969, scientists in Berkeley, California began developing a Left Ventricular Assist System (LVAS), based on a pulsed-solenoid driver concept. Development was initially funded by research contracts from the U.S. National Institutes for Health (NIH). By 1977, the world's first integrated electrical LVAS had been designed. In 1982, Novacor Medical was formed to complete development and commercialize this LVAS. With additional venture capital funding, the system was refined and qualified for clinical use. In 1984, the Novacor® LVAS was used in the world's first successful Bridge-to-Transplant (BTT) operation. (See Milestones for subsequent developmental and clinical milestones.) In 1988, Novacor Medical Corporation was acquired by Baxter Healthcare Corporation. With Baxter's support, the product was enhanced, and clinical use spread outside of North America. In 1994, the Novacor® LVAS received regulatory approval for European commercialization (CE Mark) for use as both a Bridge-to-Transplant and as a long-term alternative to medical therapy (Destination Therapy). In 1998, the Novacor® LVAS received FDA approval for U.S. sales as a Bridge-to-Transplant system. After almost a quarter-century of clinical use, the sale of the Novacor® LVAS was discontinued in 2008.
In 2000, shortly after Baxter's cardiovascular products division was spun off to Edwards Lifesciences LLC, the Novacor Division was acquired by World Heart Corporation (WorldHeart). The Novacor Medical facility located in Oakland, California is now a facility of WorldHeart.
WorldHeart was established in 1996 to develop the HeartSaverVAD™ technologies originated by the Cardiovascular Devices Division (CVD) of the University of Ottawa Heart Institute (OHI). OHI is one of Canada's leading cardiac centers, and an international center of excellence for the diagnosis, treatment, rehabilitation from and prevention of heart disease through patient care, research and education. Ottawa continues to serve as the registered office of WorldHeart Corporation.
While the HeartSaverVAD was shelved™, the technologies embodied in the Novacor® LVAS and the HeartSaver™ VAD were amalgamated in the development of the pulsatile Novacor II LVAS. The pulsatile Novacor II LVAS was designed to maintain its predecessors 's unparalleled reliability and durability, while providing a system that is smaller, more biocompatible, totally implantable, and more economical. The further development of this device is on hold due to the organization's focus on the clinical use of the Levacor VAD.
In 2005, WorldHeart acquired the assets of MedQuest Products Inc. located in Salt Lake City, Utah, adding advanced rotary pump and related enabling MagLev technology to WorldHeart's VAD platform. MedQuest was a 1993 spin-off from the University of Utah, a worldwide pioneer in artificial heart and other organ technologies since the mid-'60s. The acquisition broadened WorldHeart's product platform and is expected to make real the promise of Destination Therapy as a widely adopted treatment.
In 2006, the first human implant of the Levacor VAD was performed by a surgical team at St. Luke's Hospital, Thessaloniki, Greece. The successful implant marked the start of the feasibility clinical trial for an acute bridge-to-recovery indication. After only six weeks of support, the first Levacor VAD recipient started excursions outside the hospital and exercising regularly. The patient fully recovered his natural heart function, and the Levacor was explanted after almost three months support. Today almost 2 years later without the device, the patient continues to lead a normal and unremarkable life at home. A second patient in 2006 has had the same positive experience, which concluded the feasibility study.
The Levacor VAD is undergoing readiness to start a US Bridge-To-Transplant trial in the second half of 2009.
WorldHeart continues to expand and upgrade its Salt Lake City facilities to accommodate anticipated growth of, and focus on, its Rotary Systems product line. It recently announced the move of its headquarters to its Salt Lake City, Utah facility.
