Insurance coverage approval from the Japan Ministry of Health, Labour and Welfare

EVI announces that the “Double Cuff Tipless (DCT)” Inflow Cannula has received insurance coverage approval from the Japan Ministry of Health, Labour and Welfare (MHLW) as of November 1, 2018.

In conjunction with a miniaturized blood pump, the Double Cuff Tipless Inflow cannula is an essential part of the EVAHEART 2 Left Ventricular Assist System and currently used in the ongoing US IDE trial and soon to be launched global CE trial.

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Background:

Inflow cannula malposition may be associated with blood clot formation around the inflow cannula at the left ventricular apex and post LVAD stroke events. The EVAHEART 2 inflow cannula (Double Cuff Tipless Inflow) is intended to improve intra-ventricular washout flow, eliminating blood stagnation. The DCT inflow may be more forgiving against inflow malposition when compared to conventional LVAD inflow.

EVAHEART 2 "Double Cuff Tipless (DCT)" Inflow Cannula Approved in Japan

EVI announces that the “Double Cuff Tipless (DCT)” Inflow Cannula has gained regulatory approval by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) on October 9, 2018.

In conjunction with a miniaturized blood pump, the Double Cuff Tipless Inflow cannula is an essential part of the EVAHEART 2 Left Ventricular Assist System and currently used in the ongoing US IDE trial and soon to be launched global CE trial (EU and Canada).

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Background:

Inflow cannula malposition may be associated with blood clot formation around the inflow cannula at the left ventricular apex and post LVAD stroke events. The new EVAHEART 2 inflow cannula (Double Cuff Tipless Inflow) is intended to improve intra-ventricular washout flow, eliminating blood stagnation. The DCT inflow may be more forgiving against inflow malposition when compared to conventional LVAD inflow.