BioVentrix announces First-in-Man milestone for PliCath heart failure system

BioVentrix, developer of the PliCath HF™ System for use in Epicardial Catheter-based Ventricular Reconstruction (ECVR), today announced achievement of its First-in-Man milestone, performed on a 52-year-old male heart failure patient in Krakow, Poland. The PliCath HF System is designed to treat heart failure (HF) by reducing the enlarged Left Ventricle (LV) through an anchoring system that is delivered across the cardiac chambers with the use of a catheter. By pulling non-adjacent walls of the heart into contact, intervening scar tissue that resulted from a previous heart attack is excluded. It has been known for decades that enlarged hearts are not optimal, and the reduction in the size of the LV allows the heart to maintain adequate cardiac output without working so hard.

“In the US, nearly 70 percent of the five million heart failure patients develop the disease because of scar on their ventricle from a previous heart attack. This minimally-invasive device will extend effective treatment to a large group of patients where none is currently available.”

Lead surgeon Prof. Jerzy Sadowski, of the Pope John Paul II Hospital, Jagiellonian University in Krakow, expressed great optimism about the device. "The BioVentrix PliCath HF device performed as it was designed. This technology allowed us to perform major reconstruction of the LV on a beating heart in a matter of minutes without incisions. The patient is recovering well. This device has great promise and should help improve the quality of life of our patients suffering from heart failure."

The patient's heart size was decreased by 40%, while the ejection fraction (EF), the percentage of blood volume ejected from the ventricle after contraction, increased by 15%. In extensive animal studies, the PliCath HF System improved the EF by 13%; the End Diastolic Volume (the relaxed part of the cardiac cycle) by 18%; and the End Systolic Volume (the fully contracted part of the cardiac cycle) by 35%. Based on the outcome of this first procedure, it appears that similar results can be achieved in humans. Improvements of this magnitude in the heart size are expected to have a significant clinical effect, since there would be a decrease in the stretching of the remaining heart muscle, allowing it to pump with reduced strain.

Heart Failure is a disease with symptoms presenting shortness of breath, exercise intolerance, swelling of the ankles from fluid retention, and general fatigue. The underlying factor is that the heart is unable to pump efficiently to meet the demands of the body, consequently confining the patient to reduced physical activity. HF afflicts a large population, has no cure, and is progressively disabling. Nearly a million hospital admissions in the US are due to HF. Currently, "open heart procedures" are applied sparingly among such debilitated patients due to its invasiveness.

"Heart failure, not unlike obesity, has become a problem of epidemic proportions. The reduction in heart size that this device can achieve is the cardiac equivalent of a 40% weight loss in a morbidly overweight population," said Ken Miller, President & CEO of BioVentrix. "In the US, nearly 70 percent of the five million heart failure patients develop the disease because of scar on their ventricle from a previous heart attack. This minimally-invasive device will extend effective treatment to a large group of patients where none is currently available."