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Abre IDE study

Medtronic launches IDE Study to evaluate Abre Venous Stent

Study to enrol subjects at up to 35 sites across the US and Europe

Medtronic has initiated its investigational device exemption (IDE) study for the Abre venous self-expanding stent system. The ABRE IDE Study will evaluate the safety and effectiveness of the Abre stent in subjects with iliofemoral venous outflow obstruction. The first procedure, performed in December 2017, by Dr Erin Murphy, director of the venous and lymphatic program at Carolinas HealthCare System's Sanger Heart & Vascular Institute in Charlotte, NC, and national principal investigator for the ABRE IDE Study in the US.

The Abre stent is an investigational device in the US intended for permanent implant in the iliofemoral vein. It is pre-mounted on a 9 French delivery system and features a nitinol stent with a tri-axial shaft design. The stent utilises an open-cell design with three connection points between the cells that are intended to enable flexibility and conformability. Upon deployment, the Abre stent uses an optimized balance of strength and flexibility to exert an outward force and open the vein.

The multi-centre, single arm study intends to enrol 200 subjects with deep venous disease from up to 35 sites throughout the US 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 revascularisation (CD-TLR).

The primary safety endpoint will evaluate the incidence of composite Major Adverse Events (MAE) at 30 days following stenting of an obstruction in the iliofemoral venous segment. Data from the study will be used to support the Abre stent US pre-market approval (PMA) application for the treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.

"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," said Dr Murphy. The first procedure was performed on a patient with non-thrombotic iliac vein lesion (NIVL) who is doing well post-treatment. We are excited to continue enrolment at our sites throughout the US and Europe."

"Deep venous disease can cause pain, swelling, and blood clots, which can potentially be devastating to patients," said Dr Stephen Black, consultant vascular surgeon, Guy's and St. Thomas' Hospital, London and European principal investigator for the ABRE IDE Study. "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."

"With the growth of our superficial venous product portfolio, we have established ourselves as leaders in this space. Now, with our entry into the deep venous space, we are well positioned to offer a comprehensive portfolio for the treatment of venous disease," said Sandra Lesenfants, vice president and general manager of the endoVenous business, which is part of the Aortic & Peripheral Vascular division at Medtronic. "While our entrance into the deep venous space is recent, we believe the ABRE IDE Study and our regulatory approval in Europe positions us well for future growth in this area. We look forward to continuing to enrol patients in the IDE study and working with the clinical community to address critical needs of patients with deep venous disease."

In the US, Abre is an investigational device and not yet approved for commercial use. Abre received CE Mark approval in April of 2017 and is intended for use in the iliofemoral veins for treatment of symptomatic venous outflow obstruction.