As part of our commitment to developing solutions for the treatment of valve disease, Medtronic is sponsoring the landmark APOLLO Trial. APOLLO will evaluate transcatheter mitral valve replacement (TMVR) — a therapy designed to correct mitral regurgitation.
MR affects an estimated four million people in the United States1,2
Mitral valve leaflets become damaged or stretched out where they don’t close properly, which allows blood to flow backward causing MR
Prior heart attacks and heart disease increases the risk of developing of MR
If left untreated, MR may lead to chronic heart failure (HF), the leading cause of hospitalization in the United State and Europe
Approximately 50% of HF patients will die within five years
Approximately 10% of HF patients have symptoms, such as shortness of breath at rest
OVERVIEW OF THE INTREPID TMVR SYSTEM
The Intrepid TMVR system integrates self-expanding stent technology with a tissue heart valve to facilitate minimally invasive, catheter-based implantation.
The prosthesis is compressed inside a hollow delivery catheter and implantation is completed through trans-apical access. The prosthesis is designed to attach and conform to the native annulus without need for additional sutures, tethers, or anchors.
The device design features:
A conformable Outer Stent designed to engage the annulus and leaflets, providing fixation while isolating the inner stent from the dynamic anatomy
A flexible Brim designedto aid imaging during implantation and subsequent tissue in-growth
The circular Inner Stent houses a 27 mm tri-leaflet bovine pericardium valve
The rate of all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization at one year
Composite of all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation (or reintervention) for any reason and major bleeding at 30 days or hospital discharge whichever is longer
Change in NYHA at one year
Quality of Life (QoL) Improvements at 30 days (SF-12) and one year (KCCQ)
Echocardiographic assessments of degree of mitral valve regurgitation at one year
Days alive out of hospital at one year (all hospitalizations) from index procedure
Cardiovascular hospitalization through one year
30 days, three months, six months, and annually starting one through five years
The following table outlines inclusion and exclusion criteria for the Apollo trial.
Key Inclusion Criteria
Subject has severe symptomatic mitral regurgitation
Heart team agrees the patient is a candidate for bioprosthetic mitral valve replacement
Key Exclusion Criteria
Prior transcatheter mitral valve procedure with device currently implanted
Anatomic contraindications for the Intrepid TMVR system (e.g., annular dimensions, high risk of LVOT obstruction, transapical access, etc.)
Prohibitive mitral annular calcification
Reduced ventricular function with left ventricular ejection fraction (LVEF) <25%
Hemodynamic instability requiring either inotropic agents or mechanical circulatory support
Need for emergent or urgent surgery
U.S. Census Bureau. Statistical Abstract of the U.S.: 2006, Table 12.