Cardiac Dimensions ® Announces Three Major Publications Demonstrating Long-Term Durability, Real-World Performance, and Broad Patient Benefit of the Carillon Mitral Contour System ®

Cardiac Dimensions, a leader in transcatheter therapies for heart failure, today announced the publication of three major manuscripts that together form the most comprehensive evidence base ever assembled for transcatheter indirect mitral annuloplasty. These publications span a five-year multi-center commercial registry, the largest single-center experience across both preserved and reduced ejection fraction, and long-term survival results through ten years.

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The Carillon Mitral Contour System is the only commercially available indirect mitral annuloplasty device, designed to treat a broad and expanding population of patients living with functional mitral regurgitation. The newly published data further strengthen the clinical foundation for the therapy as Cardiac Dimensions advances toward regulatory submissions in the United States and continues to expand its commercial presence in Europe.

“Heart failure clinicians are looking for therapies that are safe, effective, and durable in real-world practice. The five-year CINCH FMR registry results stand out because they demonstrate sustained reduction in mitral regurgitation, sustained improvement in symptoms, and an excellent safety profile across a broad patient population,” said Dr. William T. Abraham, Chief Medical Officer of Cardiac Dimensions. “These results matter clinically because they reflect everyday practice rather than highly selected trial populations. The consistency of benefit in both HFrEF and HFpEF is especially meaningful. Together, these data show that the Carillon therapy has matured into a proven and reliable option for patients with functional mitral regurgitation.”

Three Publications Spanning Durability, Real-World Performance, and Broad Patient Inclusion

1. Five-Year Multi-Center Real-World Outcomes from the CINCH FMR Registry (228 Patients)

The CINCH FMR registry is the largest multi-center dataset evaluating indirect mitral annuloplasty in contemporary practice. Key findings include:

• Nearly half of all patients were free from heart failure hospitalizations through five years
• Major reduction in MR severity, with moderate-to-severe MR decreasing from 84% at baseline to 9% at one year and remaining low through five years
• More than 97% of patients maintained stable or improved MR grade across all time points
• Device- or procedure-related serious adverse events of 1.8%, demonstrating strong safety performance

2. Largest Single-Center Analysis Highlights Effectiveness Across Both HFrEF and HFpEF (204 Patients)

This single-center experience provides important insight into patient groups historically underrepresented in clinical trials. Key findings include:

• 94% of patients improved by at least one NYHA class and 98% achieved NYHA class I or II
• Significant improvements in BNP levels, left atrial size, pulmonary pressures, diastolic filling pressures, and vena contracta width
• No differences in response between HFrEF and HFpEF

3. Ten-Year Cardiovascular Survival After Indirect Mitral Annuloplasty

A single-center extension of the REDUCE FMR trial provides the longest known follow-up for any transcatheter mitral repair therapy.

• Ten-year cardiovascular survival was 66% demonstrating long-term durability and treatment impact in an advanced heart failure population
• Median survival was 5.6 years in an elderly and high-risk FMR population

“These three publications build on our extensive and growing body of evidence and represent a significant step forward for the Carillon therapy and for the field of transcatheter mitral repair,” said Rick Wypych, President and CEO of Cardiac Dimensions. “With a robust and consistent dataset now spanning multiple studies, we are energized as we advance toward U.S. approval through the EMPOWER Trial and accelerate our global commercial growth.”

The Carillon Mitral Contour System has CE Mark and is available for sale in Europe and other countries that recognize CE Mark.

About the Carillon Mitral Contour System

The Carillon Mitral Contour System is a minimally invasive device designed to treat heart failure patients with functional mitral regurgitation by reshaping the mitral valve apparatus via the coronary sinus. It is commercially available in Europe, as well as other countries, and is currently being studied in the U.S. pivotal EMPOWER Trial.

About the EMPOWER Trial

The EMPOWER Trial is a prospective, randomized, sham-controlled pivotal study evaluating the safety and effectiveness of the Carillon Mitral Contour System® in heart failure patients with mild to severe functional mitral regurgitation. Designed to enroll up to 300 patients across leading U.S. and international centers, the trial aims to support FDA approval by demonstrating the Carillon therapy’s potential to improve symptoms, cardiac structure, and long-term outcomes in a broad heart failure population.

About Cardiac Dimensions

Cardiac Dimensions is committed to addressing the rapidly growing patient population suffering from heart failure with functional mitral regurgitation. With decades of clinical experience and thousands of patients treated worldwide, the company’s Carillon device is uniquely positioned as a durable therapy designed to treat early and late-stage patients, improve symptoms and reverse disease progression. Learn more at www.cardiacdimensions.com.

CAUTION: In the United States, the Carillon Mitral Contour System is an investigational device, limited by federal law to investigational use.

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