Bellerophon Therapeutics has completed patient enrolment in its Preservation I CE Mark registration trial of Bioabsorbable Cardiac Matrix (BCM), an investigational implantable medical device being examined to prevent congestive heart failure following an acute myocardial infarction (AMI).
A total of 303 AMI patients were enrolled and treated at nearly 90 clinical sites in Australia, Europe, Israel and North America.
The double-blind, placebo-controlled trial was designed to evaluate safety and effectiveness of BCM in the prevention of ventricular remodeling and congestive heart failure, when administered following AMI.
The trial, which includes a six-month follow-up period for all patients, is expected to be completed in mid-2015.
Each year, more than 1.9 million patients suffer a heart attack in the US and European Union (EU), of which 35%-40% develop congestive heart failure within five years of the event.
If the results of the Preservation I trial are positive, the company intends to use it to form the basis for its CE marking application.
In addition, Bellerophon expects to conduct a second, larger clinical trial to support approval in the US through the premarket approval (PMA) pathway.
The trial's primary endpoint is a change in left ventricular end-diastolic volume index (LVEDVI) at six months compared to baseline.
LVEDVI is an anatomic measurement of ventricular remodeling evaluated through an echocardiogram.
Secondary endpoints of the trial include patient-reported evaluation of symptoms, function, quality of life, functional capacity, physician-assessed function, and cardiovascular events.
BCM is a liquid medical device that is administered through an injection, which is made by a minimally invasive procedure called percutaneous coronary intervention (PCI) commonly used when opening up cardiac blood vessels and placing a stent.
Following deployment, BCM flows into the damaged heart muscle where it forms a gel, which acts as a protective meshwork or scaffold within the wall of the heart's left ventricle.