Brought to you by:
Chronic venous insufficiency: Appeal over ‘not-approvable’ VenoValve fails
enVVeno Medical has announced that it received an “unfavorable” decision from the Food & Drug Administration (FDA) in response to its supervisory appeal of the “not-approvable” letter it received on Aug. 19 in response to its premarket approval (PMA) application…
enVVeno receives ‘unfavorable’ appeal decision from FDA for VenoValve device
enVVeno Medical has announced that it has received an “unfavorable” decision from the Food & Drug Administration (FDA) in response to its supervisory appeal of the not-approvable letter it received on Aug. 19 in response to its premarket approval (PMA)…
Appeal filed over ‘not-approvable’ letter for breakthrough venous valve replacement
Venous valve developer enVVeno Medical has announced that it will file a request for supervisory appeal of the “not-approvable” letter from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) received on Aug. 19,…
Celebrity-prompted awareness in vascular surgery
The vascular surgery field received a rare moment in the public spotlight recently as President Donald J. Trump was diagnosed with chronic venous insufficiency (CVI). The White House press secretary and appointed physician to the president even made statements on…
FDA deems Envveno’s VenoValve ‘not-approvable’
The Food and Drug Administration (FDA) has issued a letter to Envveno Medical stating that its VenoValve technology is “not-approvable,” a company press release published today reports. The letter was issued in response to Envveno’s premarket approval (PMA) application for…
In wake of President Trump’s chronic venous insufficiency diagnosis, SVS steps up to educate public
News that U.S. President Donald J. Trump has a vascular condition may have simultaneously revealed that a substantial seven-figure vascular surgery branding campaign was starting to yield tangible results, and provided a singular opportunity to platform the specialty as the…
VenoValve: Analysis finds similar improvement among both primary and thrombotic deep venous reflux patients
A new subanalysis of the SAVVE (Surgical antireflux venous valve endoprosthesis) trial found that there was no difference in the level of improvement in clinical outcomes and quality-of-life measures between patients who have either primary or thrombotic deep venous reflux.…
One-year SAVVE trial results are ‘most encouraging data ever produced for a bioprosthetic vein valve’
The one-year data from the SAVVE trial represent the “most encouraging clinical data that have ever been produced for a bioprosthetic deep vein valve” in more than half a century of attempts at developing such a device, according to one…
Positive one-year data for new venous valve portends promising future in chronic venous insufficiency treatment
SAVVE trial principal investigators discuss results showing 98.4% VenoValve device patency, 85% clinically meaningful benefit and an 80% rate of ulcer size reduction at 12 months. Fresh from delivering positive one-year data from the Surgical Antireflux Venous Valve Endoprosthesis (SAVVE)…
One-year data from VenoValve US pivotal trial emerges
Envveno Medical has announced that it will present one-year data on all patients from the VenoValve US pivotal trial today at the VEITHsymposium (19–23 November, New York, USA). The definitive one-year data support the application submitted earlier this week by Envveno Medical seeking…