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# FDA Rejects enVVeno Medical Venous Valve PMA
- URL: https://www.fdaweb.com/fda-rejects-envveno-medical-venous-valve-pma/
- Published: 2025-08-20T12:00:00.000Z
- Updated: 2026-09-14T15:19:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159720

FDA has issued enVVeno Medical a not-approvable letter for its PMA on VenoValve, a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency (CVI). The agency concluded that data submitted from the SAVVE study were insufficient to establish a favorable benefit-risk profile, the company says. While the trial demonstrated improvements in the revised Venous Clinical Severity Score, pain, and venous-specific quality of life, the agency said the results lacked a specific hemodynamic measurement to confirm that patient improvements were directly attributable to the device, it says, adding that the regulators also raised concerns about potential bias from study participation itself.

In addition, FDA cited safety risks associated with the open surgical procedure required to implant VenoValve, including re-hospitalizations, and suggested that such risks would not be expected with a non-surgical valve replacement, the company says.

“We are obviously disappointed by the FDA’s decision,” an enVVeno Medical statement says. “The results showed significant clinical improvement in patients who had failed standard care. With the VenoValve being the only difference in their treatment, it is hard to not attribute the improvement to the device.”

The company says it is reviewing FDA’s feedback and considering next steps, which could include a meeting to discuss resubmission requirements or an appeal of the decision.

CVI, which affects an estimated 2.5 to 3.5 million patients in the U.S., currently has no effective treatment options, underscoring the unmet need, enVVeno says.