US-based medical device company BioVentrix has secured US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to begin its pivotal clinical trial on the Revivent TC TransCatheter Ventricular Enhancement System.
The clinical trial ALIVE (American Less Invasive Ventricular Enhancement), will assess the safety and efficacy of Revivent, which is a hybrid closed-chest transcatheter procedure to treat patients afflicted with ischemic cardiomyopathy.
The medical procedure involves reshaping and restoring the left ventricle (LV) done by implanting micro-anchoring pairs in the LV to separate the affected myocardium from the healthy tissue.
The ALIVE trial will include 120 patients at up to 20 sites across the nation with a primary endpoint analysis at one year.
It will focus on the areas including volume reduction, ejection fraction, quality of life (QOL), New York Heart Association (NYHA) Class, six minute walk test, and rehospitalisation.
BioVentrix medical affairs vice-president and cardiologist Dr Ryan Brown said: "The Revivent TC system has recently demonstrated efficacy in clinical trials performed in the EU.
"This technology provides a less invasive means for LV scar reduction / exclusion in patients with prior myocardial infarction and LV dysfunction.
"Restoration of LV morphologic and volume characteristics in a less invasive manner, compared with current surgical ventricular restoration, will ideally avail this technology and procedural concept to a larger patient population."
The Revivent system is implanted by the LIVE procedure which necessitates a more invasive surgery. However, small titanium anchors are placed instead along the outer surface of the heart and along one of the interior walls via a closed-chest, endovascular approach.
The anchors are then pulled together alienating the scarred and non-functioning heart wall which results to an immediate reduction of the ventricular volume by 30-40%.