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Hancock Jaffe Laboratories, Inc.: Hancock Jaffe Concludes Successful VenoValve Pre-IDE Meeting with FDA


Hancock Jaffe Laboratories, Inc.: Hancock Jaffe Concludes Successful VenoValve Pre-IDE Meeting with FDA
IRVINE, CA / ACCESSWIRE / January 12, 2021 /
Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that it has successfully concluded its VenoValve Pre-IDE meeting with the U.S. Food and Drug Administration ( FDA ). Topics presented at the meeting included the background and clinical need for the VenoValve, proposed study design, patient monitoring for safety and efficacy, bench testing protocols, and the VenoValve first-in-human results.
The proposed protocol for the U.S. pivotal trial is expected to be very similar to the protocol that was used for the VenoValve first-in-human study, which was successfully completed at the end of 2020, and which included endpoints for reflux time (the backwards flow of blood), VCSS scores (disease manifestations), VAS scores (pain), and VIENES quali ....

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