Thoratec's Bleeding Edge
The striking results of the REMATCH trial, demonstrating the efficacy of Thoratec's ventricular assist device to extend the life of terminal heart failure patients, is heartening clinicians and patients and opening up new markets for ventricular assist device manufacturers. Thoratec still faces FDA and reimbursement hurdles before its devices become long-term therapies in large volumes of patients. Meanwhile, the competition hopes to profit from the precedent-breaking REMATCH results, and overtake Thoratec's lead with claims of technological superiority in the long-term heart assist market.
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Thoratec's 34% increase in the revenue for 2008 was largely due to the introduction of its left ventricular assist device HeartMate II, a small axial flow pump weighing only 12 oz. while previous devices weighed three pounds. It took more than seventeen years for the HeartMate II to wend its way through development to the marketplace success that it is today, and that's not unusual in the LVAD space. But now, next generation LVADs with advantages are already nipping at Thoratec's heels. Thoratec's solution: consolidation. On February 13, Thoratec announced that it would acquire publicly-traded Australian LVAD company HeartWare International for $282 million, half in stock and half in cash.
The first left ventricular assist device (LVAD) to receive FDA approval as a primary therapy (rather than as a bridge to heart transplantation) is an older generation device with limited durability. With its third generation LVAD, MiTiHeart hopes it has the proper combination of a simple, robust and manufacturable design, low power consumption, and low rates of hemolysis, to serve a large, unmet need in congestive heart failure patients needing a permanent implant.
With both paracorporeal and implantable ventricular assist devices in development for heart failure, Berlin Heart's goal is to enter the treatment continuum at an earlier stage and enable patients to avoid transplants, and perhaps even enable heart recovery.