Company History
WorldHeart's roots in heart-assist device technologies go back over thirty-five years. 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. 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.
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). 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.
The technologies embodied in the Novacor® LVAS and the HeartSaver™ VAD are now being amalgamated in the development of the Novacor II LVAS. This effort is being led by members of the original Novacor® LVAS development team, with 200 collective years of LVAS design experience. The Novacor II LVAS will maintain the current device's unparalleled reliability and durability, while providing a system that is smaller, totally implantable and more economical.
In 2005, WorldHeart acquired the assets of MedQuest Products Inc. located in Salt Lake City, Utah, adding an advanced rotary pump to WorldHeart's VAD platform. The acquisition broadens WorldHeart's product platform and helps 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 the surgical team at St. Luke's Hospital, Tessaloniki, Greece. The successful implant marks the start of the feasibility clinical trial. After only six weeks of support, the first Levacor VAD recipient has started excursions outside the hospital and is exercising regularly.
