Carbomedics Prosthetic Heart Valve (CPHV)
by Corcym S.r.l. PMA
Active
PMA P900060
Overview
The Carbomedics Prosthetic Heart Valve (CPHV) is a mechanical heart valve designed to replace a damaged or diseased native heart valve. It is classified as a heart-valve, mechanical device and functions to maintain unidirectional blood flow through the heart, reducing symptoms of valvular heart disease such as congestive heart failure, arrhythmias, or thromboembolic events.
This device is supplied sterile and intended for single-use implantation during open-heart surgery. It is regulated under FDA Premarket Approval (PMA) and falls under device class III. The valve is available in various sizes to accommodate different patient anatomies, and proper storage requires adherence to manufacturer guidelines to ensure sterility and functionality. Its design and materials are intended for long-term durability within the cardiovascular system.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP900060 | Date29 Sep 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- HEART-VALVE, MECHANICAL
- PMA Number
- FDA Product Code
- LWQ
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Other devices from Corcym S.r.l.
Questions
What types of patients is the Carbomedics Prosthetic Heart Valve designed to treat, and how is sizing determined?
The Carbomedics Prosthetic Heart Valve (CPHV) is intended for patients with damaged or diseased native heart valves requiring surgical replacement to restore unidirectional blood flow. Sizing is critical to ensure proper function and is determined based on the patient’s anatomy, with the valve available in multiple sizes to accommodate different anatomical requirements. The exact sizing guidelines should be followed as per the manufacturer’s instructions to ensure optimal performance and compatibility.
Is the Carbomedics Prosthetic Heart Valve reusable, or is it meant for single-use only?
The CPHV is explicitly designed for single-use implantation during open-heart surgery. It is supplied sterile and intended to be used once, after which it should not be reused. This ensures patient safety and maintains the device’s integrity and sterility.
How should the Carbomedics Prosthetic Heart Valve be stored to maintain its sterility and functionality?
The CPHV must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This typically involves keeping the valve in its original packaging, in a clean and dry environment, away from direct sunlight or extreme temperatures. Adherence to these instructions is essential to prevent contamination or damage before implantation.
What regulatory pathway does the Carbomedics Prosthetic Heart Valve follow, and what does this mean for its use?
The CPHV follows the FDA Premarket Approval (PMA) pathway, which is required for Class III devices like mechanical heart valves. This means the device has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use in replacing damaged or diseased heart valves. Clinicians and buyers should confirm compliance with FDA regulations and follow approved surgical protocols when using the device.