Organ Care System (OCS) Heart System

The OCS Heart System is specifically authorized for preserving donor-after-brain-death (DBD) hearts that were initially deemed unsuitable for transplantation due to prolonged cold static cardioplegic preservation—such as those with over 4 hours of cross-clamp time. This system supports extended ex vivo evaluation by maintaining cardiac function, oxygenation, and viability, allowing transplant centers to assess hearts that might otherwise be discarded, thereby expanding the donor pool for transplantation.

The OCS Heart System is supplied as a **sterile, single-use device**, meaning each unit is intended for one procedure only. This design ensures sterility and functionality are maintained, but it also requires strict adherence to manufacturer guidelines for storage and handling to prevent contamination or degradation before use. Proper storage conditions are critical to preserving its performance for the intended ex vivo preservation application.

The OCS Heart System follows the **FDA Premarket Approval (PMA) pathway**, granted under PMA number **P180051**. This classification (Class III) indicates it carries higher risk and requires rigorous pre-market evaluation to ensure safety and effectiveness. Clinically, this means its use is governed by FDA-authorized protocols, and it must be employed strictly as indicated for ex vivo preservation of DBD hearts with specific preservation limitations, as outlined in the approval.

Unlike traditional cold static cardioplegic preservation, which is limited by prolonged cross-clamp times (e.g., >4 hours), the OCS Heart System provides **active perfusion**—delivering controlled oxygenation, temperature regulation, and hemodynamic support. This enables extended ex vivo preservation while maintaining cardiac function and viability, allowing for more thorough donor heart evaluation and preparation before transplantation, even for hearts previously considered unsuitable.