The FDA’s bureaucratic blockade is crushing a medical breakthru. enVVeno Medical’s VenoValve, a game-changing implant for severe chronic venous insufficiency (CVI), transformed MANY lives in the SAVVE trial. This condition will touch roughly 1 in 5 people to some extent and seriously affects 2.5–3.5 million Americans with pain, venous stasis ulcers, and even limb loss. 

Despite the improvement of 93% of patients who had not improved after conventional therapies like limb compression and elevation, despite a WHOPPING 73% drop in pain, despite an all but unheard of 0 rate of infection after 66 femoral implants, and remembering the amazing achievement of  meeting every single study end point, the FDA is ignoring the endorsement of some of the world's most eminent vascular surgeons and have REJECTED the VenoValve.  

The FDA has nitpicked over one missing (but referenced deep in the packet) “hemodynamic metric,” ignoring clear venous pressure drops and life-changing results ACROSS THE BOARD!. Their rejection isn’t science; it is intentional red tape and it is CORRUPT.   Despite their ludicrous assertions which defy common sense, these patients aren’t placebo cases mesmerized into thinking they are better — they are walking, golfing, gardening,  and enjoying coming and going .... they are LIVING ROBUST LIVES again.   Well over 60 lives have been marvelously improved.    Read all about it here at enVVeno's home page.     

Instead of applauding this amazing achievement The FDA’s rejection condemns millions to continue enduring pain unnecessarily.  Many will lose limbs that could have been saved.  While the FDA quibbles over 2 mm of mercury (having tolerated much higher differences in other applications) people suffer.            

The FDA even impugned the VenoValve study citing the fact that there wasn't a blinded study performed - as if surgically implanting placebo devices into human subjects were somehow ethical or possible, a no-win situation.       

enVVeno  delivered a true breakthrough... a marvel  akin to a technical miracle.   They created a first of its class game changer that has performed flawlessly through years of trials and scrutiny and has transformed well over 60 lives with nary a hiccup.   However, they didn't walk on water and clearly it just isn't a big enough miracle for the FDA.             

We who sign this demand our government immediately reverse the decision and grant the licenses to these devices.    The safety and efficacy endpoints having been surpassed with no reasonable safety concern or device failure to justify the rejection, doing so has been a travesty and should be summarily reversed immediately.

We who sign this petition hereby petition the Secretary of Health and Human Services, the honorable Robert F Kennedy Jr.  for an investigation into the people, processes and failures that enabled this failure of compassion and common sense.   

 

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Those who will help please do as much as you can in the following order:   

1 Please sign this petition, THANK YOU!!!   

2 Please share this link with at least 5 people.  Ask everyone to consider signing it.   Anyone can suffer this disease (1 in 5 likely will) and the FDA's withholding approval at this point is withholding life and limb saving treatments.   !   

3  Contact HHS Secretary Robert F. Kennedy Jr. at SecKennedy@hhs.gov or hhs.gov/about/contact-us and request his immediate and urgent attention to this matter!

4 Email the FDA ombuds@oc.fda.gov or call 301-796-8530 to demand action and investigate this ridiculous rejection .

Thank You!