Solution

HFpEF BY THE NUMBERS

Patients with HFpEF Experience Worsening Symptoms and Decreased
Quality of Life 1,2

Patients living with HFpEF in the U.S.
Million
patients Are 60 Years of Age (or older) When diagnosed
1 %
patients are female
1 %
Life expectancy once diagnosed
< 1 Years
total expected cost to the health care system by 2030
$ 1 Billion

CONSEQUENCES OF HFpEF

HFpEF is Characterized by a Stiffened Left Ventricle and
Impaired Relaxation

The left ventricle is the chamber of the heart that is responsible for pumping blood out to the body. When it becomes stiff and can’t relax it leads to multiple problems.

  • Increased LV pressure, meaning the pressure in the left ventricle is too high
  • Impaired LV filling, meaning the left ventricle can’t fill with blood during diastole the way it should
  • Decreased LV distensibility, meaning the left ventricle can’t stretch and contract the way it should
As a result patients with HFpEF experience:
  • Increasing hospitalizations
  • Increasing cost to health care system
  • Increasing risk of other organs failing, like the lungs or kidneys
  • Increasing mortality
  • Decreasing functional capacity (aka exercise tolerance)
  • Decreasing quality of life

TODAY, HFpEF PATIENTS ARE POOR CANDIDATES OR NOT CANDIDATES AT ALL FOR ADVANCED THERAPIES

New Procedure Could Offer Hope For Patients with HFpEF

One way to reduce the strain on the left ventricle is to modify the pericardium. The pericardium is the sac that the heart sits in. In patients with HFpEF it can further contribute to the increasing demands put on the left ventricle. Surgery to modify the pericardium is not typically offered to patients because the risks associated with the surgical procedure are too high.

 

Heart Failure Solutions is developing a novel approach for pericardial modification to allow the LV to better fill and enhance the cardiac output. This minimally invasive approach is designed to minimize the risks compared to conventional surgery;
allowing patients with HFpEF to benefit.

Animal studies have been completed with evidence of improved LV pressures

Pre-Clinical Evidence is Promising

Over 36 animal studies have been conducted to date, focused on hemodynamic assessment pre and post pericardial modification as well as device design improvements. Results revealed an improvement in LV pressure sustained at 4 weeks.

Following the successful acute and chronic animal studies, Heart Failure Solutions will be looking forward to initiating an IDE early feasibility study.

*CAUTION: The PeriCut System is an Investigational Device. It is limited by United States law to Investigational Use only.

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References:

1.Virani, S. et al. Heart Disease and Stroke Statstitics – 2021 Update. Circulation. 2021; 143:e254-e743
2.https://www.healthline.com/health/heart-failure/heart-failure-preserved-ejection-fraction#life-expectancy