The Edwards SAPIEN XT transcatheter heart
valve builds upon the proven SAPIEN
For high-risk patients and those who are not suitable for open-heart surgery, another option is now available - transcatheter aortic valve replacement (TAVR) - a less invasive procedure that does not require open-heart surgery. TAVR produces results in lengthening patients’ lives.
SAPIEN XT TAVR Indication
The Edwards SAPIEN XT transcatheter heart valve, model 9300TFX, systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient of ≥ 40 mmHg, or a peak aortic-jet velocity of ≥ 4.0 m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system, who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).
Once a patient is referred to a TAVR hospital, a Heart Team will conduct a thorough evaluation to determine whether the patient is an appropriate candidate.
Confirm the Patient is Diagnosed with Severe Symptomatic Native Aortic Stenosis
Confirm the Patient has been Evaluated by Two Cardiac Surgeons and Meets the Indication for TAVR
Evaluate the Aortic Valvular Complex Using Echocardiography
Evaluate the Aortic Valvular Complex and Peripheral Vasculature Using MDCT
Evaluate the Aortic Valvular Complex and Peripheral Vasculature Using Catheterization
Determine Access Route for Transcatheter Heart Valve Replacement