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NEWS
New Interim Venous Ulcer Healing Data from the enVVeno Medical VenoValve(R) Pivotal Trial to be Presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting on June 21, 2024
enVVeno Medical announced the presentation of new interim venous ulcer healing data from the VenoValve U.S. pivotal trial at the Society for Vascular Surgery 2024 Vascular Annual Meeting on June 21, 2024. The data, presented by Dr. Cassius Iyad Ochoa Chaar of Yale School of Medicine, includes healing and improvement rates for venous ulcers among 21 patients reaching the one-year milestone. The study involves patients with severe venous ulcers who had undergone multiple existing treatments. The FDA requires one-year data on all SAVVE patients for the VenoValve's PMA application, expected to be filed in Q4 2024.
Positive
New interim data from VenoValve U.S. pivotal trial to be presented at a key medical meeting.
Data will include healing and improvement rates for venous ulcers at the one-year milestone.
Presentation by a prominent vascular surgeon from Yale School of Medicine.
Addressing an unmet medical need for severe chronic venous insufficiency.
FDA has asked for one-year data to support the PMA application, showing regulatory interest.
Negative
The study involves patients who had already failed multiple existing treatments, indicating a challenging patient group.
The FDA requires comprehensive data, potentially delaying the market approval process.
Potential recurrence of venous ulcers, a factor that will be monitored and reported.
Positive
New interim data from VenoValve U.S. pivotal trial to be presented at a key medical meeting.
Data will include healing and improvement rates for venous ulcers at the one-year milestone.
Presentation by a prominent vascular surgeon from Yale School of Medicine.
Addressing an unmet medical need for severe chronic venous insufficiency.
FDA has asked for one-year data to support the PMA application, showing regulatory interest.
Negative
The study involves patients who had already failed multiple existing treatments, indicating a challenging patient group.
The FDA requires comprehensive data, potentially delaying the market approval process.
Potential recurrence of venous ulcers, a factor that will be monitored and reported.
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