Shoreview, MN — November 24, 2025 — Heart Failure Solutions, a medical technology company developing innovative solutions for patients with HFpEF, today announced the successful first-in-human use of its PeriCut System in a patient treated at Mayo Clinic, marking a significant milestone in the advancement of therapies for individuals living with HFpEF.
The procedure was performed by Dr. Ammar Killu, MD, Investigator at Mayo Clinic as part of the company’s FDA-approved Early Feasibility Study. In total, three patients now have been successfully treated and are recovering well.
PeriCut System is designed to reduce symptoms by improving hemodynamics, removing fluid, and restoring LV function. Patients with HFpEF currently have limited treatment options, and many continue to experience debilitating symptoms and impaired quality of life despite available therapies.
“This first procedure represents a meaningful step toward transforming care for patients living with HFpEF,” said Mark Strong, Founder & CEO. “We are encouraged by the initial results and look forward to continuing the clinical evaluation of this technology as we work to deliver new hope to patients who urgently need better therapies.”
The Early Feasibility Study will enroll up to 15 patients across leading medical centers in the United States. Study endpoints include safety, feasibility, hemodynamic improvement, and functional status. Data from this study will support future clinical development and regulatory pathways.
Heart Failure Solutions will continue enrolling patients and expects to report early clinical learnings at THT in 2026.
About Heart Failure Solutions
Heart Failure Solutions is a clinical-stage medical technology company dedicated to developing innovative therapies for patients with HFpEF. The company’s mission is to help patients live longer for the moments that matter! For more information, visit www.heartfailureinc.com
Media Contact
Mark Strong
Founder / CEO
Heart Failure Solutions
651-269-4640
Mark@Heartfailureinc.com
This communication may contain forward-looking statements which involve uncertainties and actual results may differ materially.
