The Revivent TC System* extends the Less Invasive Ventricular Enhancement™ (LIVE™) procedure, pioneered by BioVentrix as an alternative to conventional surgical ventricular restoration (SVR), by enabling a closed-chest approach. Placement of the Revivent TC System is done without sternotomy or ventriculotomy, so the need for cardiopulmonary bypass is eliminated. The proprietary transcatheter delivery system enables volume reduction of the left ventricle (LV) via placement of anchors designed to exclude scarred myocardial tissue from the left ventricle while also restoring its more natural conical shape. Recent peer-reviewed studies have found that LV volume is the best predictor of survival in ischemic cardiomyopathy patients.1
The Revivent™ Myocardial Anchoring System and Revivent TC System use identical titanium micro-anchoring devices for treating the underlying cause of heart failure. The Revivent TC System employs a hybrid endovascular technique performed in the hybrid cath lab that will allow physicians to treat a more fragile patient population by eliminating the risks of open surgical intervention.
|Clinical Benefits||Revivent||Revivent TC Under Clinical Study|
|Directly reduces LV radius||Yes||Yes|
|Reduces LV wall tension||Yes||Yes|
|Returns the LV to a more conical shape||Yes||Yes|
|Treats the progression of LV enlargement||Yes||Expected|
|Treats the cause of heart failure symptoms||Yes||Expected|
|One-year durability data||
|Clinical results forthcoming|
|Improvements in NYHA class, QOL score & six-minute walk test||Yes||Expected|
|Device Placement||Revivent||Revivent TC Under Clinical Study|
|Procedure descrption||Trans-epicardial surgical & less invasive||Hybrid transcatheter-thoracoscopic|
|Physician team||Cardiac surgeon||Cardiac surgeon & cardiologist|
|Procedure location||Operating room suite||Interventional hybrid lab|
|Requires cardiopulmonary bypass support||Optional||No|
|Device placed concurrently with other procedures or as a stand-along procedure||Either||Either|
|Less invasive approach than conventional SVR||Yes||Yes|
The Revivent TC™ TransCatheter Ventricular Enhancement System requires regulatory approval and is not yet commercially available.
1Kramer DG et al. Quantitative Evaluation of Drug or Device Effects on Ventricular Remodeling as Predictors of Therapeutic Effects on Mortality in Patients With Heart Failure and Reduced Ejection Fraction: A Meta-Analytic Approach. J Am Coll Cardiol. 2010; 56(5):392-406.