enVVeno Medical has unveiled a new expedited development plan for its transcatheter-based replacement venous valve, enVVe.
The new plan is anticipated to help lower the development cycle of the valve by roughly six months.
Expected to start early next year, a six-month pre-clinical GLP study is the next step in the development of the valve. It is an FDA prerequisite for the pivotal study.
The company plans to be ready to seek investigational device exemption (IDE) approval for the pivotal trial at the end of next year.
The non-surgical replacement venous valve is delivered through a minimally invasive procedure that requires no general anaesthesia or overnight hospital stay.
It is produced using specially formulated biocompatible nickel and titanium alloy, which self-expands upon deployment. The valve has a delivery profile of only 13 Fr when crimped.
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Designed to accommodate the natural dilation and contraction of the vein, the valve will be available in three sizes for a proper fit across a wide range of vein sizes.
Envveno CEO Robert Berman said: “Based upon the knowledge we gained from the VenoValve, our successful pre-clinical testing for envve, feedback that we recently received from the FDA and our strong capital position, which is now sufficient to begin the envve pivotal study, we have decided to expedite envve’s development and immediately begin preparations for the envve pivotal trial.”
The company has also attained full enrolment in the US pivotal trial of Venovalve, a replacement venous valve that is implanted through an open surgical procedure.
Initial topline safety data from the SAVVE trial is anticipated to be revealed in the fourth quarter of this year, with full enrolment set to occur earlier than expected.
Envveno also plans to announce initial topline efficacy data from the trial in the second quarter of next year, while it intends to file for FDA approval of the device in the third quarter of the same year.