Medtronic Launches IDE Study of Abre Venous Stent for Deep Venous Disease
January 26, 2018—Medtronic announced the initiation of its investigational device exemption (IDE) study that will evaluate the safety and effectiveness of the company's Abre venous self-expanding stent system in patients with iliofemoral venous outflow obstruction.
According to the company, the multicenter, single-arm study intends to enroll 200 patients with deep venous disease at up to 35 sites throughout the United States and Europe. The primary efficacy endpoint will evaluate patency at 12 months, which is defined by freedom from occlusion and freedom from clinically driven target lesion revascularization. The primary safety endpoint will evaluate the incidence of composite major adverse events at 30 days after stenting of an obstruction in the iliofemoral venous segment.
The Abre stent is premounted on a 9-F delivery system and features a nitinol stent with a triaxial shaft design. The stent utilizes an open-cell design with three connection points between the cells that are intended to enable flexibility and conformability. Upon deployment, the Abre stent balances strength and flexibility to exert an outward force and open the vein.
Medtronic noted that data from the study will be used to support the premarket approval application to the US Food and Drug Administration for the Abre stent to treat symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.
The Abre stent is an investigational device in the United States intended for permanent implant in the iliofemoral vein and is not yet approved for commercial use. In April 2017, Abre received European CE Mark approval for use in the iliofemoral veins for treatment of symptomatic venous outflow obstruction.
Erin Murphy, MD, performed the first procedure in the study in December 2017. Dr. Murphy, who serves as the National Principal Investigator for the ABRE IDE study in the United States, is Director of the Venous and Lymphatic Program at Carolinas HealthCare System's Sanger Heart & Vascular Institute in Charlotte, North Carolina.
In the company's announcement, Dr. Murphy commented, "The launch of the ABRE IDE study marks the beginning of an important journey to establish new options for the treatment of deep venous disease. The first procedure was performed at Sanger Heart & Vascular Institute on a patient with nonthrombotic iliac vein lesion who is doing well posttreatment. We are excited to continue enrollment at our sites throughout the United States and Europe."
Stephen Black, MD, who is Consultant Vascular Surgeon at Guy's and St Thomas' Hospital in London, United Kingdom, serves as European Principal Investigator for the ABRE IDE study.
Dr. Black stated, "Deep venous disease can cause pain, swelling, and blood clots, which can potentially be devastating to patients. As a result, there is a critical need for treatment options that are safe, effective, and durable. We look forward to using the Abre stent in the restoration of patency in patients with deep venous disease."