Safety and Efficacy Study of OmniWave Endovascular System to Treat Deep Vein Thrombosis

Study of the OmniWave Endovascular System in Subjects With Lower and Upper Extremity Deep Vein Thrombosis - SONIC I Study

This is a prospective, multi-center single arm registry to assess the use of the OmniWave Endovascular System in subjects presenting with either lower or upper extremity acute (symptoms have been present for greater than or equal to 14 days) DVT.

Inclusion Criteria:

• DVT confirmed by venographic and ultrasound imaging, which has been symptomatic for a maximum of 14 days, or diagnosed within past 14 days defined as either first episode (no prior history in affected segment), or recurrent episode.
• Written informed consent
• Agreement to comply with follow up requirements

Exclusion Criteria:

• Known R-L shunt, pulmonary A-V malformation
• Excessive tortuosity and/or sharp angulation in target treatment zone
• Isolated calf vein thrombosis
• Isolated DVT in veins peripheral to axillary vein
• Thrombus in peripheral vessel smaller than 5 mm
• Target treatment zone cannot be adequately accessed within the 100 cm working length of device