Edwards EVOQUE Tricuspid Valve Replacement System
Artificial valve to address tricuspid valve regurgitation
Edwards EVOQUE Tricuspid Valve Replacement System
In a groundbreaking move, the FDA has recently approved the Edwards EVOQUE Tricuspid Valve Replacement System for market distribution. The device was developed by Edwards Lifesciences LLC. This innovative system offers hope for patients suffering from severely leaky tricuspid valves, a condition known as tricuspid regurgitation.
The Edwards EVOQUE system features an artificial tricuspid valve, aptly named the EVOQUE valve, constructed from cow tissue affixed to a self-expanding nickel-titanium frame for structural support. What sets this system apart is its ability to replace the tricuspid valve without necessitating open-heart surgery, a significant advancement in cardiac care.
How it works
During a minimally invasive procedure, the surgeon places the compressed EVOQUE valve onto a delivery catheter and guides it through the femoral vein in the groin until it reaches the diseased tricuspid valve. Once in position, the valve expands and anchors itself within the patient’s existing valve, effectively restoring proper blood flow within the heart.
Intended use
The intended use of the EVOQUE valve is to address tricuspid regurgitation caused by an enlarged heart or damaged native valve flaps. By reducing the backflow of blood through the tricuspid valve, patients may experience improved quality of life, relief from symptoms like fatigue, and enhanced exercise capacity.
Clinical studies
Clinical studies have demonstrated promising outcomes with the EVOQUE valve. In a comparative study involving 96 patients treated with the valve and medication versus 54 patients treated solely with medication, significant findings emerged. The majority of patients receiving the EVOQUE valve saw a reduction in severe valve leakage, translating to improved quality of life and symptom relief.
Who should not use this device
However, it is important to note that the EVOQUE system may not be suitable for everyone. The system should not be used for patients unable to tolerate specific blood thinners, those with allergies to nickel or titanium, or individuals with active infections in the heart or elsewhere in the body.
Significant milestone
Overall, the FDA’s approval of the Edwards EVOQUE Tricuspid Valve Replacement System represents a significant milestone in cardiovascular medicine, offering new hope and improved outcomes for patients with tricuspid regurgitation.
Links
Read the FDA product announcement here.