TransMedics (NSDQ:TMDX) this week said that the FDA Circulatory Systems Device Advisory Panel voted in favor of the OCS Heart System.
The FDA panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh the risks. The panel also voted 10 to 6, with 2 abstaining that there is reasonable assurance that the OCS Heart System is effective. It also voted 9 to 7, with 2 abstaining, that there is reasonable assurance of the OCS Heart System’s safety.
“This is a critical milestone for the OCS Heart technology on the path to a potential FDA approval, which I am confident would benefit patients in need of heart transplantation in the U.S. We are looking forward to working collaboratively with the FDA as it completes its review,” president and CEO Waleed Hassanein said in a news release. “We are grateful for the help and support of our investigators, the patients who enrolled in our trials, and the donor families who gave our patients the gift of life by supporting organ donation. In addition, we want to thank the respected members of the Advisory Panel and the FDA review team for their thoughtful discussion and deliberations on this important PMA. We are now laser-focused and looking forward to our next important business milestones planned for 2021: scheduling the OCS Liver FDA Advisory Panel Meeting, the final readout of the OCS Heart DCD trial and the filing of the DCD Heart PMA supplement to eventually expand our OCS Heart indication into DCD heart transplantation in the U.S.”
The Circulatory Systems Device Advisory Panel voted positively following a review of TransMedics’s clinical evidence from the OCS Heart Expand Trial, its Continued Access Protocol results and the OCS Heart Proceed II trial. The OCS Heart Expand trial met its primary effectiveness endpoint and showed that the system resulted in successfully transplanting 84%. The post-transplant rate of severe Primary Graft Dysfunction was 8%. Patient survival at 30 days post-transplant was also 97% and all-cause survival was 92% at 6 months and 87% at 12 months. Cardiac-related survival was 96% at 6 and 12 months.
“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 hearts, we can access to a significantly greater suitable donor poll,” Jacob Schroder, surgical director of heart transplantation at Duke University and principal investigator for the OCS Heart Expand trial, said in a news 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.”
The FDA will consider the opinions and recommendations of the Advisory Committee, but will ultimately make a decision regarding whether to approve the premarket approval applications for the system after completion of its review of the applications, according to TransMedics.