PMA application submitted for VenoValve device

enVVeno Medical today announced it has submitted an application with the U.S. Food and Drug Administration (FDA) seeking approval to market the VenoValve—a surgical venous valve implant for chronic venous insufficiency—in the USA. Definitive one year data from the application…
Bioprosthetic venous valve imparts sustained clinical improvement at one year regardless of CEAP category

A new paper that drills into the impact of a novel bioprosthetic venous valve replacement by CEAP (Clinical, Etiological, Anatomical and Pathophysiological) classification shows sustained clinical improvement regardless of grading, with patients classed as C4b exhibiting greater resolution of symptoms…
SVS, AVF bring the latest innovations in venous disease treatment to VAM

During the first day of VAM 2024, the Society for Vascular Surgery (SVS) and American Venous Forum (AVF) have co-sponsored a session on the latest innovations in the delivery of venous disease treatment. Madhavi Meka, MD, a clinical associate professor…
Prosthetic valve implantation shows “vast” improvements in deep chronic venous insufficiency

“The surgical challenges of repairing deep venous reflux have been present for more than a generation. It is worth reflecting on the fact that this new technology has made the majority of patients vastly better,” were the words of principal…
Bioprosthetic venous valve: ‘We want to know that this is really working’

A key investigator in efforts to tackle chronic venous insufficiency (CVI) with an bioprosthetic venous valve replacement talks about progress being made with surgical and endovascular versions of the device—and surgical community skepticism. Jorge Ulloa, MD, has not long since…
AVF 2023: Investigators report update on three-year first-in-human results for bioprosthetic venous valve

Researchers in Colombia behind the first-in-human study of a novel bioprosthetic venous valve designed to treat chronic venous insufficiency (CVI) reported three-year results among eight patients during the 2023 annual meeting of the American Venous Forum (Feb. 22–25) in San…
First-in-human patients continue to benefit from VenoValve at average of three years post-surgery, new data show

Positive long-term, three-year observational data from a cohort of patients that participated in the previously concluded VenoValve (Envveno Medical) first-in-human clinical trial were recently presented at the VEITHsymposium 2022 (Nov. 15–19) in New York City. Principal investigator Jorge Hernando Ulloa, MD,…
The top 10 most popular Vascular Specialist stories in March

Among the posts catching Vascular Specialist readers’ eyes last month were the digital flipbook version of our March print edition, a new study looking at the Society for Vascular Surgery (SVS) open abdominal aortic aneurysm (AAA) recommendations, and an interview…
AVF 2022: VenoValve improvement ‘maintained’ for 2.5 years without adverse events

Envveno Medical announced positive 30-month data from the first-in-human trial of the VenoValve bioprosthetic potential venous valve replacement during the 2022 American Venous Forum (AVF) annual meeting (VENOUS2022) held in Orlando, Florida (Feb. 23–26). The results showed that VenoValve recipients—now an…
Envveno Medical reports successful completion of first VenoValve surgery in US pivotal trial

Envveno Medical—formerly Hancock Jaffe Laboratories—recently announced that the first VenoValve surgery in the company’s SAVVE US pivotal trial for the VenoValve has been successfully completed. The surgery was performed by Adriana Laser, MD, associate professor of surgery at Albany Medical…

