enVVeno Medical (NVNO) Announces Release of One-Year VenoValve Data
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enVVeno Medical Corporation (NASDAQ: NVNO), a company setting new standards of care for the treatment of venous disease, today announced the publication of its research paper, First one-year human success for VenoValve in treating patients with severe deep venous insufficiency, in the peer-reviewed journal, Vascular and endovascular surgery.
This first-in-man (FIH) trial was a prospective, non-randomized, single-center study. The study enrolled 11 patients with severe deep venous CVI (patients with CEAP C5 and C6 disease). Patients enrolled in the VenoValve FIH trial demonstrated significant improvement in all study endpoints, including a 54% overall improvement in reflux (backflow of blood), a 56% improvement in manifestations of disease, as measured by Venous Clinical Severity Scores (“rVCSS”), and a 76% improvement in pain, as measured on a visual analog scale (“VAS”), all at the end of the d one year from preoperative levels. There were no device security events.
“While we recently presented longer-term thirty (30) month data at the American Venous Forum conference in Orlando, it is important that VenoValve data be published in respected peer-reviewed journals as part of of the paradigm shift we are conducting for the treatment of deep vein CVI,” commented Robert Berman, Chief Executive Officer of enVVeno Medical. “The current standard of care for deep vein CVI has significant gaps and we believe that the VenoValve could be the effective solution that frustrated doctors and their patients have been looking for for decades.”
The published article is available on the Journal website and on the Scientific publications and presentations page of the Company’s website.
The VenoValve is the company’s first-in-class surgical implantation solution, currently undergoing the pivotal U.S. SAVVE trial for safety and efficacy as a treatment for chronic deep venous insufficiency (CDI). ). Recruitment of patients at study sites across the United States is ongoing. The surgically implanted VenoValve is designed to act as a one-way valve to help restore proper directional blood flow up the leg to return enough blood to the heart. The VenoValve has received Breakthrough Device designation from the United States Food and Drug Administration.
Patients with leg swelling, pain, non-healing leg sores, enlarged veins and/or brownish or bluish skin discoloration – who may also have leg pain when standing or walking – can be candidates for the SAVVE test. Interested patients can learn more about the SAVVE trial and find a study center near them by visiting www.VenoValve.com.