Vesper - Model DUO - Venous Stent System

Types of Venous Obstruction:

Thrombotic Obstruction2-5

• Associated with acute deep vein thrombosis (DVT) or chronic post-thrombotic syndrome (PTS) due to a DVT
• Acute DVT impacts more than 800,000 people annually in the US and can result in significant disability from pulmonary embolism and chronic venous insufficiency, especially when proximal iliofemoral veins are involved
• Even with anticoagulation, PTS occurs in 50% of those with acute DVT and is the most frequent complication

Non-Thrombotic Obstruction, also known as non-thrombotic iliac vein lesion (NIVL)6

• Caused by compression of the iliac vein by predominantly the left or right iliac artery and less frequently by the hypogastric artery
• May-Thurner Syndrome (MTS) is the classic left-sided proximal lesion (compression) of the left iliac vein caused by the abrupt crossing of the right iliac artery
• The right iliac artery may be related to proximal or distal NIVL of the right iliac vein, with the majority of lesions occurring near the right common iliac vein. Although less common, the left hypogastric artery crossing may also lead to left distal NIVL
• 90% of patients with significant symptoms of pain, swelling, skin changes, or venous stasis ulcers are found to have NIVL by IVUS examination7

The DUO-HYBRID Stent

• Self-expanding, open-cell nitinol stent features custom segments to address the challenging dynamics of deep vein mechanics

• High crush resistant segment – provides crush resistance against outward radial force associated with May-Thurner area

• Gradual transition segment transitions to a highly flexible segment designed to prevent foreshortening, fish scaling and optimize fatigue resistance for long-term durability in high strain areas such as the inguinal ligament

• Inflow reinforcement located at the caudal end protects against edge crush, maintaining venous inflow

Intended Use:

• The Vesper DUO Venous Stent System is intended for use in the iliac and common femoral veins for improving luminal diameter in symptomatic venous outflow obstructions

Contraindications for Use:

• Patients with a known hypersensitivity to nickel-titanium alloy (Nitinol)

• Patients unable to receive standard medication used for interventional procedures including anticoagulants, contrast agents and antiplatelet therapy

• Patients who are judged to have a lesion that prevents complete inflation of a balloon dilation catheter or proper placement of the stent or the stent delivery system

• Tortuous vascular anatomy significant enough to prevent safe introduction and passage of the device

• The Vesper DUO stent is not designed for use in procedures that require jugular or contralateral access and therefore is absolutely contraindicated from these access sites

MRI SAFETY INFORMATION

Non-clinical testing has demonstrated that the DUO-HYBRID and DUO-EXTEND Venous Stents are MR Conditional when used per the intended use for all clinically relevant lengths. A patient with this device can be safely scanned in an MR system meeting the following conditions:

• Static magnetic field of 1.5 T or 3 T, only

• Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m)

• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of2-W/kg (Normal Operating Mode)

• Circularly polarized (quadrature-driven) coil only

Under the scan conditions defined, an implant from the Vesper DUO Venous Stent System is expected to produce a maximum temperature rise of less than 2.0°C after 15-minutes of continuous scanning (i.e., per pulse sequence).

In non-clinical testing, the image artifact caused by the device extends approximately 5-mm from the Vesper DUO Venous Stent System when imaged with a gradient echo pulse sequence and a 3-T MR system. The lumen of this stent could be visualized on the T1-weighted, spin echo and gradient echo MR images.