Mitroflow Aortic Pericardial Heart Valve

The Mitroflo Aortic Pericardial Heart Valve is available in five sizes: 19 mm, 21 mm, 23 mm, 25 mm, and 27 mm. These sizes are designed to accommodate varying patient anatomies, allowing surgeons to select the appropriate valve size to ensure proper hemodynamic function and fit during aortic valve replacement. The sizing range reflects the device’s intent for both pediatric and adult patients with diseased or malfunctioning native or prosthetic aortic valves.

The Mitroflo Aortic Pericardial Heart Valve is explicitly intended for **single-use** in a sterile surgical setting. This is a standard practice for pericardial tissue-based heart valves to maintain sterility and prevent cross-contamination, ensuring patient safety during implantation.

The Mitroflo Aortic Pericardial Heart Valve is classified as a **Device Class III** and is regulated under the **FDA_PMA (Premarket Approval)** pathway, with PMA Number **P060038**. This classification indicates it is a high-risk device requiring rigorous clinical evaluation before approval. Clinically, this means the valve has undergone thorough testing to demonstrate safety and effectiveness for replacing diseased, damaged, or malfunctioning native or prosthetic aortic valves, providing confidence in its use for aortic valve replacement surgeries.

Since the Mitroflo Aortic Pericardial Heart Valve is supplied in a **sterile** configuration for single-use, clinicians must ensure it is stored according to manufacturer guidelines to preserve sterility and integrity. Proper storage typically involves maintaining the valve in its sealed packaging, away from extreme temperatures or moisture, until immediately before use in the operating room. Always follow the included instructions for preparation and handling to avoid contamination or damage.