Breakthrough Designation Expands to Both HFrEF and HFpEF Populations
Alleviant Medical, a leader in minimally invasive heart failure treatments, has achieved two significant milestones with the U.S. FDA: approval to initiate a pivotal trial for heart failure with reduced ejection fraction (HFrEF) and breakthrough designation for its novel atrial shunt technology. This marks a major advancement in addressing the unmet needs of over 26 million heart failure patients globally.
Key Highlights
- FDA Breakthrough Designation: Already granted for heart failure with preserved ejection fraction (HFpEF), the designation now extends to HFrEF.
- No-Implant Shunt Technology: Alleviant’s innovative device creates an atrial shunt without leaving behind a permanent implant, reducing potential complications.
- Pioneering Clinical Trials: The company is conducting two pivotal trials (ALLAY-HF for HFpEF and the newly approved ALLAY-HFrEF) informed by prior sham-controlled studies.
ALLAY-HFrEF Trial Overview
- Principal Investigators:
- Dr. Gregg Stone, Icahn School of Medicine at Mount Sinai.
- Dr. James Udelson, Tufts Medical Center.
- Focus: Evaluating the safety and efficacy of the Alleviant System in HFrEF patients (LVEF ≤ 40%) who remain symptomatic despite guideline-directed medical therapy.
- Design: Adaptive trial enrolling ~350 randomized patients globally in early 2025.
Potential Impact
Heart failure, a leading cause of morbidity and mortality, affects millions of patients with limited treatment options. Alleviant’s no-implant approach offers the potential for improved outcomes and quality of life, addressing a critical gap in care for both HFrEF and HFpEF populations.
Dr. Stone emphasized,
“The ALLAY-HFrEF trial builds on prior evidence showing significant benefits of atrial shunt therapy, now delivered without permanent implants.”
Dr. Udelson added,
“This groundbreaking therapy has the potential to transform outcomes for millions suffering from heart failure.”
With FDA approvals for pivotal trials and breakthrough status, Alleviant Medical is poised to redefine heart failure treatment. The company’s innovative approach aligns with its mission to deliver evidence-based therapies that improve patient care globally.
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