Medtronic Launches IDE Study to Evaluate the Abre(TM) Venous Self-Expanding Stent System in Patients with Deep Venous Disease
January 26, 2018 at 02:00 pm
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Medtronic plc announced the initiation of its investigational device exemption (IDE) study for the Abre(TM) 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 was performed in December of 2017, by Dr. Erin Murphy, director of the venous and lymphatic program at Carolinas HealthCare System'sSanger Heart & Vascular Institute in Charlotte, North Carolina, and national principal investigator for the ABRE IDE Study in the U.S. The multi-center, single arm study intends to enroll 200 subjects with deep venous disease from up to 35 sites throughout the U.S. 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 (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 U.S. pre-market approval (PMA) application for the treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease. Medtronic estimates deep venous obstruction affects more than 24 million individuals worldwide. Deep venous obstruction occurs when veins in the deep venous system become compressed and restrict blood flow. It can result in discomfort and pain, limit a patient's mobility, and impair quality of life. The Abre stent is an investigational device in the U.S. 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 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 uses an optimized balance of strength and flexibility to exert an outward force and open the vein.
Medtronic plc is one of the world leaders in designing, manufacturing and marketing of medical equipment. Net sales break down by sector of activity as follows:
- general and minimally invasive surgery (28.8%): surgical equipment, intra-operative monitoring systems, ventilation systems, etc.;
- cardiac rhythm management (18.6%): implantable cardiac pacemakers, implantable defibrillators and automatic external defibrillators, cardiac ablation probes, etc.;
- vascular diseases and cardiac surgery (17.4%): coronary stents, endoprostheses for aortal pathologies, distal protection systems, catheters, heart valve prostheses, auto-transfusion equipment, cardiac ablation devices, etc.;
- spinal disorders (14.1%): spinal prostheses, disc prostheses, cerebral stimulation systems, bone graft technologies and mini-invasive spinal surgery, etc. The group also develops medical imagery-guided surgical navigation systems activity;
- neurovascular, ear, nose and throat (ENT) and pelvic diseases (8.2%);
- diabetes management (7.4%): internal and external glycemia monitoring systems and insulin pumps;
- neurological disorders (5.5%): neurostimulation and pumped medication administration products, diagnostic tools, etc.
Net sales are distributed geographically as follows: Ireland (0.3%), the United States (50.9%) and other (48.8%).
MEDTRONIC PLC 
