HFpEF Therapy Used for First Time in Human Patients

Heart Failure Solutions has disclosed 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 heart failure with preserved injection fraction (HFpEF).

The procedure was performed by Mayo Clinic investigator Ammar Killu, M.D., as part of the company’s U.S. Food and Drug Administration-approved Early Feasibility Study. In total, three patients have been successfully treated and are recovering well.

The left ventricle (LV) is the heart chamber responsible for pumping blood out to the body. When it becomes stiff and cannot relax, it can lead to multiple problems. One way to reduce the LV strain is to modify the pericardium, the sac in which the heart sits. Surgery to modify the pericardium is not typically offered to patients because the risks are too high.

The PeriCut System—Heart Failure Solutions’ approach for pericardial modification—allows the LV to better fill and enhance cardiac output. This minimally invasive approach is designed to minimize the risks compared to conventional surgery, allowing HFpEF patients to benefit.

“This first procedure represents a meaningful step toward transforming care for patients living with HFpEF,” Heart Failure Solutions Founder/CEO Mark Strong said. “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 U.S. medical centers. Study endpoints include safety, feasibility, hemodynamic improvement, and functional status. Study data will support future clinical development and regulatory pathways.

Heart Failure Solutions will continue enrolling patients and expects to report early clinical learnings at THT this year.

Heart Failure Solutions is a clinical-stage medical technology company developing therapies for HFpEF patients. The firm is based in Minneapolis.