First FDA-Approved Pioneering Heart Surgery Based on Matrix Therapy Found To Be Successful

First FDA-Approved Pioneering Heart Surgery Based on Matrix Therapy Found To Be Successful

When a person suffers a heart attack, the heart tissue becomes damaged, scarred and the organ can lose its ability to function properly. There is currently no treatment to fix the scar tissue that is formed after a heart attack; this is especially relevant since both the scar tissue and the weakened heart muscle can lead to heart failure.

Regenerative therapies for the heart are mainly based on gene therapy or the use of stem cells; however, these approaches do not treat the scar tissue. A new minimally invasive method has been developed where an extreme makeover of the heart is performed by injecting a natural matrix directly into the damaged heart tissue. The procedure, called endocardial matrix (ECM), can be performed while the patient is awake.

Dr. Amit N. Patel and a cardiovascular team at the University of Utah Health Science are now the first team in the world to perform this pioneering heart procedure in a 72-year-old patient who had suffered a serious heart attack.

As part of the procedure, a 3D map of the patient’s heart is generated in order to identify which tissues of the heart muscle are healthy, damaged or scarred. Based on the map, the surgeon then injects the matrix into the damaged and scarred tissue. The matrix is based on a mixture of VentriGelTM, a hydrogel that mimics the native scaffolding (extracellular matrix) from the heart. After the procedure, patients are advised undergo magnetic resonance imaging (MRI) of the heart, with three-month intervals, to determine whether the ECM technique repaired the damaged cardiac tissue.

“The new procedure involving ECM therapy is Cardiac Regeneration 2.0. It allows us to treat patients before they progress to heart failure,” explained Dr. Patel in a news release. According to the team, the patient was able to return to her normal, active lifestyle as an attorney after the intervention.

This is the first clinical trial approved by the U.S. Food and Drug Administration (FDA) for heart treatment based on matrix therapy. The trial will assess the safety and efficacy of the procedure, and is expected to enroll patients who experienced a first heart attack in the past 3 years and exhibit a weaken heart muscle or are considered at risk of heart failure. The FDA has approved 18 sites for the first phase of the trial, and expects that at least three years of studies and trials will be required before the procedure is available to the public.

Currently, it is estimated that around 785,000 new heart attack cases occur in the United States each year, and that at least 22% of the men and 46% of the women who suffer a heart attack will develop heart failure within the following six years.

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