InvestorsHub Logo
icon url

9HikeDiscGolf

08/29/17 1:57 PM

#18066 RE: Craig305 #18064

1 week, 1 month, 1 year, or 10 years.. No idea when..

IMO
icon url

Biotech_Tradez

08/29/17 2:02 PM

#18068 RE: Craig305 #18064

In med devices there are generally two trials, a pilot trial and a pivotal trial.

How long the FDA requests that treatment last for and how long the patients have to be followed for is anyone's guess until they actually meet with the FDA and agree on the structure of the clinical trial.

The pilot trial could only last a few months and its intent is to show safety and an effect. The pivotal trial looks at efficacy and that may require a longer duration of treatment, for example a year of treatment and my require that ENDV follow patients for 3 to 5 years in the heart. This is based on other heart failure medical devices, such as devices that use electrical stimulation to assist the heart in pumping blood.