TVMR With the Innovalve System Trial - Pilot in Georgia

TVMR With the Innovalve System Trial - Pilot in Georgia

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

The study is a multi-center, First-In-Human, prospective, single pilot study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Inclusion Criteria:

• Clinically significant, symptomatic mitral regurgitation
• High risk for open-heart surgery
• Meets anatomical criteria

Exclusion Criteria:

• Unsuitable anatomy
• Patient is inoperable
• EF<25%