VentrAssist™ left ventricular assist device: clinical trial results and Clinical Development Plan update

Abstract

The efficacy and safety data from a clinical trial of the VentrAssist were favourable and resulted in gaining European regulatory approval for this indication. Notably, the survival success rate for the VentrAssist was higher than that reported for other left ventricular assist devices. The overall number of implants with the VentrAssist has now surpassed that of any other third-generation centrifugal device.

Axial and centrifugal continuous-flow rotary pumps: A translation from pump mechanics to clinical practice

“…31 The reported incidence of hemolysis for the HeartMate II axial rotary pump is 0.06, 0.02, and 0.13 events per patient-year in its BTT U.S., destination therapy U.S., and European multicenter clinical trials, respectively. 33 In a study comparing hemolysis indices in CF LVAD patients 34 supported by the axial CF rotary pump (HeartMate II) and the (VentrAssist) [35][36] centrifugal CF rotary pump, patients with the centrifugal LVAD displayed normal haptoglobin levels, low plasma free hemoglobin, and moderately increased LDH. In comparison, the HeartMate II patients showed lower haptoglobin and higher free hemoglobin and LDH values.…”

A Prospective, Multicenter Trial of the VentrAssist Left Ventricular Assist Device for Bridge to Transplant: Safety and Efficacy

“…5,12,13 Briefly, the pump ( Figure 1) was implanted via a sternal incision in the posterior rectus sheath or in a pre-peritoneal position. The inflow cannula was connected to the left ventricular apex and the outflow cannula to the ascending aorta.…”

“…5,11 The first implant of the VentrAssist occurred in 2003, 11 with an updated implant report published in 2006. 13 We now present the first full report from a prospective, international trial of the VentrAssist LVAD as BTT.…”

Haemolysis in patients with ventricular assist devices: major differences between systems☆

“…We compare three different VADs: two left ventricular systems, that is, a implantable centrifugal pump [7] and an implantable axial pump [8] and a paracorporeal pneumatic system with two chambers which supports both ventricles [9].…”