The US-based enVVeno Medical intends to use the data from the SAVVE trial for US Food and Drug Administration pre-market approval of the VenoValve device
enVVeno has concluded the enrolment for VenoValve trial. (Credit: valelopardo from Pixabay)
enVVeno Medical, a medical device company with a focus on venous disease treatment, has completed the 75-person enrolment in the SAVVE trial in the US for the VenoValve and the final precursor.
VenoValve is said to be a first-in-class surgical replacement venous valve. It is designed to treat deep venous Chronic Venous Insufficiency (CVI).
The US-based enVVeno Medical intends to use the data from the SAVVE trial for the US Food and Drug Administration (FDA) pre-market (PMA) approval of the VenoValve device.
In July this year, the medical device firm registered 57 people for SAVVE and had anticipated finishing full enrolment by the end of the year.
Due to full enrolment occurring earlier than anticipated, initial topline efficacy and safety results from SAVVE are now anticipated to be available in Q2 of 2024 and Q4 of this year, respectively.
The VenoValve PMA eligibility is anticipated to be available in Q3 of next year.
enVVeno Medical CEO Robert Berman said: “We attribute the surge in demand in SAVVE to a combination of factors including the positive results that our primary investigators are experiencing, their familiarity and affinity for the VenoValve surgical procedure and the lack of effective treatment options for the large patient population that suffer from deep venous CVI.
“Early completion of enrolment for a surgical study in the current challenging hospital environment is a testament to the dedication of our entire clinical team, which is led by Dr. Marc. Glickman, our senior vice president and chief medical officer, and includes our in-house clinical specialists, site coordinators, and primary investigators.”
Additionally, the clinical-stage company is engaged in the development of the enVVe valve. It is claimed as a non-surgical based replacement venous valve, delivered by transcatheter through a minimally invasive procedure.
The medical device firm also announced plans to expedite the development of enVVe. The strategy is expected to cut the enVVe development cycle by around six months.
The next phase of replacement venous valve development includes a six-month pre-clinical GLP study, which the company anticipates starting in early 2024 and which is an FDA requirement for the enVVe trial.
By the end of 2024, the company anticipates applying for an Investigational Device Exemption (IDE) for the enVVe study.