Charles Sternberg, Assistant Editor04.08.21
The United States Patent and Trademark Office (USPTO) has issued the first patent covering Hancock Jaffe Laboratories Inc.’s VenoValve. The patent is entitled Implantable Vein Frame and is U.S. patent number 10,959,841.
The company recently announced that only twenty-eight days after filing, the U.S. Food and Drug Administration (FDA) approved the company’s Investigational Device Exemption (IDE) application to begin the U.S. pivotal trial for the VenoValve. Known as the SAVVE study, the trial is a prospective, non-blinded, single arm, multi-center study of 75 Chronic Venous Insufficiency (CVI) patients to be enrolled at up to 20 U.S. centers.
“We will continue to work with agencies like the FDA and USPTO, and other regulatory authorities throughout the world towards our ultimate goal of reaching the millions of patients suffering from CVI,” said Hancock Jaffe CEO, Robert Berman. “We believe that the VenoValve will set a new standard of care for CVI patients and will establish Hancock Jaffe as a leading provider of innovative medical devices for peripheral vascular disease.”
About CVI
CVI occurs when valves inside the veins of the leg fail, causing blood to flow in the wrong direction (reflux), and increasing venous pressure (venous hypertension). This results in leg swelling, pain, open sores (venous ulcers) and reduced mobility for patients. CVI makes everyday tasks such as bathing, sleeping and walking extremely difficult for patients. The current standard of care for deep venous CVI sufferers includes compression garments and leg elevation.
Leading hospitals and top vascular surgeons throughout the U.S. have expressed interest in participating in the SAVVE study. The company has begun the process of fulfilling conditions for study initiation outlined by the FDA and seeking Institutional Review Board (IRB) and other necessary approvals from potential SAVVE sites. The company expects to begin patient enrollment in the third quarter of 2021 and will provide periodic updates.
Approximately 2.4 million people in the U.S. suffer from CVI due to reflux in the deep venous system. Estimates indicate that direct medical costs from CVI in the U.S. exceed $38 billion each year. There are currently no FDA-approved devices or effective treatments for deep venous CVI.
The company recently announced that only twenty-eight days after filing, the U.S. Food and Drug Administration (FDA) approved the company’s Investigational Device Exemption (IDE) application to begin the U.S. pivotal trial for the VenoValve. Known as the SAVVE study, the trial is a prospective, non-blinded, single arm, multi-center study of 75 Chronic Venous Insufficiency (CVI) patients to be enrolled at up to 20 U.S. centers.
“We will continue to work with agencies like the FDA and USPTO, and other regulatory authorities throughout the world towards our ultimate goal of reaching the millions of patients suffering from CVI,” said Hancock Jaffe CEO, Robert Berman. “We believe that the VenoValve will set a new standard of care for CVI patients and will establish Hancock Jaffe as a leading provider of innovative medical devices for peripheral vascular disease.”
About CVI
CVI occurs when valves inside the veins of the leg fail, causing blood to flow in the wrong direction (reflux), and increasing venous pressure (venous hypertension). This results in leg swelling, pain, open sores (venous ulcers) and reduced mobility for patients. CVI makes everyday tasks such as bathing, sleeping and walking extremely difficult for patients. The current standard of care for deep venous CVI sufferers includes compression garments and leg elevation.
Leading hospitals and top vascular surgeons throughout the U.S. have expressed interest in participating in the SAVVE study. The company has begun the process of fulfilling conditions for study initiation outlined by the FDA and seeking Institutional Review Board (IRB) and other necessary approvals from potential SAVVE sites. The company expects to begin patient enrollment in the third quarter of 2021 and will provide periodic updates.
Approximately 2.4 million people in the U.S. suffer from CVI due to reflux in the deep venous system. Estimates indicate that direct medical costs from CVI in the U.S. exceed $38 billion each year. There are currently no FDA-approved devices or effective treatments for deep venous CVI.
