Michael Barbella, Managing Editor05.18.21
The U.S. Food and Drug Administration (FDA) has approved Hancock Jaffe Laboratories Inc's Investigational Device Exemption (IDE) application to begin a U.S. pivotal trial for the VenoValve.
“We are delighted the FDA has approved our IDE application to begin the VenoValve pivotal trial, which should allow us to begin to gather the clinical data necessary to demonstrate that the VenoValve is a safe and effective treatment for patients with deep venous CVI,” said Hancock Jaffe CEO Robert Berman. “This approval brings us one step closer to achieving our goal of establishing a new standard of care with the VenoValve for the millions of patients suffering from the debilitating effects of CVI who have no effective treatment options today.”
VenoValve is an implantable valve designed to restore proper directional blood flow for patients with Chronic Venous Insufficiency (CVI) of the deep veins of the leg, a condition that afflicts approximately 2.4 million patients in the United States and for which there are currently no effective treatments.
The SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) Trial is a prospective, non-blinded, single arm, multi-center study of 75 CVI patients to be enrolled at up to 20 U.S. centers. The trial’s primary effectiveness endpoint is a reduction in reflux at six months, and the primary safety endpoint is the absence of a major adverse event (MAE), defined as mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis or pulmonary embolism, at 30 days post-implantation. Secondary endpoints include disease manifestations (rVCSS), pain perception (VAS), ulcer healing and recurrence, quality of life, and the absence of MAEs throughout the study. The FDA has recommended that the company provide one year safety and effectiveness data from the pivotal trial to support a pre-marketing authorization (PMA) application for commercialization. Patients enrolled in the SAVVE Trial will be followed for a period of five years.
These are the same endpoints that Hancock Jaffe used for its successful VenoValve first-in-human trial. One-year results from this trial, released in December 2020, demonstrated that patients treated with VenoValve experienced significant improvement in all study endpoints, and the device showed a good safety profile. Interim results from the study were recently published online in the Journal of Vascular Surgery.
CVI occurs when valves inside the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and creating venous hypertension. This results in leg swelling, pain, open sores (venous ulcers) and reduced mobility for patients. CVI is a debilitating condition that can make everyday tasks such as bathing, sleeping and walking extremely difficult for patients. The current standard of care for deep venous CVI sufferers consists of compression garments and leg elevation.
Hancock Jaffe has begun to qualify sites that have expressed interest in participating in the SAVVE study. The company will immediately begin to fulfill conditions for study initiation outlined by the FDA and seek Institutional Review Board (IRB) and other necessary approvals from potential SAVVE sites. The company expects sites to join the SAVVE study on a rolling basis following receipt of the necessary site approvals and documentation and appropriate site training. The company expects to begin patient enrollment in the third quarter of 2021 and will provide periodic updates.
“We are delighted the FDA has approved our IDE application to begin the VenoValve pivotal trial, which should allow us to begin to gather the clinical data necessary to demonstrate that the VenoValve is a safe and effective treatment for patients with deep venous CVI,” said Hancock Jaffe CEO Robert Berman. “This approval brings us one step closer to achieving our goal of establishing a new standard of care with the VenoValve for the millions of patients suffering from the debilitating effects of CVI who have no effective treatment options today.”
VenoValve is an implantable valve designed to restore proper directional blood flow for patients with Chronic Venous Insufficiency (CVI) of the deep veins of the leg, a condition that afflicts approximately 2.4 million patients in the United States and for which there are currently no effective treatments.
The SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) Trial is a prospective, non-blinded, single arm, multi-center study of 75 CVI patients to be enrolled at up to 20 U.S. centers. The trial’s primary effectiveness endpoint is a reduction in reflux at six months, and the primary safety endpoint is the absence of a major adverse event (MAE), defined as mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis or pulmonary embolism, at 30 days post-implantation. Secondary endpoints include disease manifestations (rVCSS), pain perception (VAS), ulcer healing and recurrence, quality of life, and the absence of MAEs throughout the study. The FDA has recommended that the company provide one year safety and effectiveness data from the pivotal trial to support a pre-marketing authorization (PMA) application for commercialization. Patients enrolled in the SAVVE Trial will be followed for a period of five years.
These are the same endpoints that Hancock Jaffe used for its successful VenoValve first-in-human trial. One-year results from this trial, released in December 2020, demonstrated that patients treated with VenoValve experienced significant improvement in all study endpoints, and the device showed a good safety profile. Interim results from the study were recently published online in the Journal of Vascular Surgery.
CVI occurs when valves inside the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and creating venous hypertension. This results in leg swelling, pain, open sores (venous ulcers) and reduced mobility for patients. CVI is a debilitating condition that can make everyday tasks such as bathing, sleeping and walking extremely difficult for patients. The current standard of care for deep venous CVI sufferers consists of compression garments and leg elevation.
Hancock Jaffe has begun to qualify sites that have expressed interest in participating in the SAVVE study. The company will immediately begin to fulfill conditions for study initiation outlined by the FDA and seek Institutional Review Board (IRB) and other necessary approvals from potential SAVVE sites. The company expects sites to join the SAVVE study on a rolling basis following receipt of the necessary site approvals and documentation and appropriate site training. The company expects to begin patient enrollment in the third quarter of 2021 and will provide periodic updates.
