2018 CE Marking 2019 objective
<p>Apr 10, 2018 09:24 PM</p>
<p>
30% done for PIVOTAL study (= 30% of 20 = 6 => will do 14 more)</p>
<p>
opening Bois-d'Arcy plant.</p>
<p>
pre-submit early feasibility study to FDA.</p>
<p>
want to market for heart failure.</p>
<p>
feasibility study was only 4 patients.</p>
<p>
will implant about 20 patients;</p>
<p>
for end-stage biventricular failure.</p>
<p>
want to show 6 month survival.</p>
<p>
In France and in Kazakhstan, Czeck Republic and Denmark.</p>
<p>
sill accel. pt enrollment.</p>
<p>
100% successful implantation; time cut by 21%</p>
<p>
will get 3 more countries... expects to end PIVOTAL implantations this year!</p>
<p>
prostheses operating on test benches!!!</p>
<p>
</p>
<p>
</p>
<p>
</p>