Less Invasive Ventricular Enhancement™ (LIVE™).

The world's only reshaping, restorative LV therapy.

Less Invasive Ventricular Enhancement therapy is an innovative, off-pump (i.e., beating heart) procedure that helps restore the native functional efficiency of the left ventricle, rather than relying on a surrogate pumping device or other invasive treatment. The LIVE procedure provides physician teams with a gentler surgical option, offering the potential for more consistent and favorable surgical outcomes, while giving heart failure (HF) patients and their families renewed hope for a more productive life. The LIVE procedure can be performed as a separate, stand-alone procedure, concurrent with other procedures (e.g., CABG) or during other occasions when a sternotomy is already employed. Neither a myocardial incision nor cardiopulmonary bypass is required.

Prior to the LIVE procedure using the Revivent™ Myocardial Anchoring System, reshaping of the left ventricle used an invasive procedure known as Surgical Ventricular Restoration (SVR), which required stopping the beating heart and supporting it with cardiopulmonary bypass, while incisions into the heart muscle were made to remove the scarred, non-functioning LV tissue. The invasive nature of SVR limits the number of patients for whom the procedure may be performed due to the fragile nature of HF patients.

The LIVE procedure patient profile.

The LIVE procedure and Revivent System are indicated for use in symptomatic patients that do not receive adequate relief from other medical or device therapies for HF and with the following clinical profile:

Previous acute myocardial infarction with discrete, akinetic or dyskinetic scar in the anteroseptal or apical regions of the LV

Symptomatic cardiac dysfunction causing HF symptoms

Myocardial viability in the regions of the LV remote to the scar

LVESVI >60mL/m2 as noted on echocardiography or cardiac MRI

As high as 40%-50% of patients are considered non-responders to cardiac resynchronization therapy.2

PliCathHF System Investigator Brochure, IB050004, Rev. G. February 13, 2012.

Birnie, DH. The problem of non-response to cardiac resynchronization therapy. Current Opinion in Cardiology. 2006;21(1):20-26.