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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,…
Answering the questions of appropriate outcome measures after intervention for deep reflux as promising venous valve technology emerges
“The path from initial trials to meaningful clinical data will not be easy,” writes Fedor Lurie (Toledo, USA) of new venous valve technologies. There is an old saying that goes, “As surgeons, we change the anatomy to improve physiology”. Correction…
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.…
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)…
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…
Cook Medical treats first patient in first-in-human clinical trial for venous valve
Cook Medical recently announced that the first patient has been treated in a clinical study to evaluate a new venous valve designed for treating chronic venous insufficiency (CVI). The patient was treated by principal investigator Mauricio Alviar, MD, a vascular…
Initial results from first-in-man trial of prosthetic VenoValve demonstrate promise, says investigator
PALM BEACH, Fla.—The initial results of an ongoing first-in-man study in Colombia that saw the implantation of a prosthetic venous valve in 15 patients appear promising, with improvement in clinical outcomes and quality of life evaluation, delegates at the Southern…