Some people wear their hearts on their sleeves, but TransMedics is all about its “heart in a box”—and now, so is an FDA advisory panel, which voted in favor of agency approval for the donor heart preservation technology.
The OCS Heart System essentially acts as a miniature ICU on wheels. Using warm perfusion and monitoring technology, the system keeps donor hearts at a metabolically active state equivalent to one inside the human body to ensure they stay viable for transplant as long as possible.
In a clinical trial focusing on donor hearts that may not have been usable if preserved with typical cold storage techniques, more than 80% were successfully transplanted with the help of the OCS Heart System. Those transplants resulted in a 95% one-month survival rate, about equal to the national average for all heart transplants.
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After reviewing this and other clinical data, the FDA’s Circulatory Systems Device Advisory Panel, a group of 18 outside medical experts, voted 12 to five, with one abstaining, that any risks associated with the system are outweighed by its benefits.
In another vote, 10 of the panelists agreed that there is reasonable assurance that the technology is effective. The question of whether there is reasonable assurance of its safety, meanwhile, was decided by a much slimmer margin: nine to seven, with two abstentions.
Though the votes aren’t binding, the FDA will take them and any other opinions or reservations expressed by the panelists into account when deciding whether to grant premarket approval to the OCS Heart System.
“For decades we have talked about heart transplant being supply-limited. If approved by the FDA, with the use of OCS Heart System for extended criteria donors and DCD [donation after cardiac death] hearts, we can access a significantly greater suitable donor pool,” Jacob Schroder, lead investigator in the OCS Heart Expand Trial, said in a release.
"As the donor pool expands, more patients can have access to this life-saving therapy. If the OCS Heart System is approved, I believe the industry will reverse its thinking and open up the ‘demand’ to a greater patient population that never had a chance at a new heart and a better life,” Schroder added.
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Now, in addition to moving forward in the approval process for its heart storage system, TransMedics—a Fierce 15 winner in 2016—will also begin scheduling an FDA panel review of OCS Liver, President and CEO Waleed Hassanein said in the release.
TransMedics has already received FDA approval for the OCS Lung, which operates similarly to the heart-preserving system. It has been cleared for preservation and ex vivo assessment of donor lungs, including some initially believed to be unacceptable for transplant based on the limitations of cold storage practices, such as those donated after brain death or circulatory death.