This article was originally published in Start Up
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.
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After struggling for years to gain momentum, the ventricular assist device market appears finally to be coming of age. Second-generation VAD designs are performing well and seem to have largely addressed the pump durability and safety issues of the past that stymied growth and prevented this market from reaching its full potential. In the process, these new pumps, and their third-generation counterparts now waiting in the wings, are revitalizing interest in VADs among both physicians and patients, and propelling this potential multibillion dollar market to the forefront once again.
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.
FDA action awaits Sun’s manufacturing facility in Halol after it failed to adequately address GMP deviations, though India’s top-ranked drug firm appears to have effectively lowered its dependence on the site that has had a patchy compliance run.