Innovation introduced by ImCardia® Diastolic Assist Device
CorAssist Cardiovascular Ltd has developed an external device named ImCardia®. The ImCardia® is designed for the treatment of HFpEF patients and/or patients with diastolic dysfunction secondary to aortic valve stenosis who are in NYHA Class III-IV heart failure.
The ImCardia® is an ‘energy-transfer’ device comprising of two main parts – elastic elements and attachment screws – which are attached to the external left ventricular surface. The device is designed to harness energy produced by the Left Ventricle (LV) during systole and releases that energy during diastole enhancing ventricular relaxation dynamics and filling performance.
24 months safety in humans
The clinical study of the ImCardia® for DHF was approved by the Ethics Committees of three institutions; Instituto Nacional de Salude (Paraguay), Pauls Stradins Clinical University Hospital Development Society (Latvia) and Novosibirsk Blood Circulation Pathology Research Institute named after ACAD. E.N. MESHALKIN (Russia). Between April 2008 and June 2009, 19 aortic valve replacement candidates were were enrolled to the ‘ImCardia® for DHF’ Study. The clinical study was divided into two groups: 10 patients were implanted with the IMCardia® as an add-on procedure to AVR and 9 were enrolled to a control group with AVR only.
The study demonstrated that the passive elastic device which transfers energy from systole to diastole, is safe for long-term implantation, and suggested that it could improve diastolic performance by a significant decrease in left atrial size beyond that expected from AVR alone.