Clinical efficacy was evaluated using the Villalta score at Baseline compared to 30 days Post-EkoSonic® study treatment procedure. Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease.

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, 'Number analyzed' signifies number of limbs analyzed at specified timepoints.

Clinical efficacy was evaluated using the Villalta score at Baseline compared to 30 days Post-EkoSonic® study treatment procedure. Limbs with revascularization procedures were considered non-responders. Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease.

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Change in blood flow was calculated by time to washout in the affected segments in the participants. Time to femoral vein (FV) washout and external iliac vein (EIV) washout was reported.

ITT population included all enrolled participants for whom EkoSonic® treatment was initiated. Here, 'Overall number of participants analyzed'/'Overall Number of Units Analyzed' signifies the number of participants/units evaluable for this outcome measure and 'Number analyzed' signifies number of limbs/participants analyzed at specified timepoints.

Major bleeding was defined as: Fatal bleeding; and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or bleeding causing a fall in hemoglobin of ≥2.0 grams/deciliter (g/dL), or leading to transfusion of ≥2 units of whole blood or red blood cells. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated.

The Ouriel score was designed to provide a more accurate quantitative estimate of the thrombus mass by calculating a volumetric index for all the venous segments. 10 venous segments were considered. Included segments were the inferior vena cava, common iliac veins, external iliac veins, internal iliac veins, common femoral veins, superficial and deep femoral veins, and popliteal veins and segments of the anterior tibial veins, posterior tibial veins, and peroneal veins. A normalized volumetric score was calculated for each segment by combining measurements from computed tomography, ultrasonography, and venography. Partially occluded veins were assigned a score of one-half the score value for the segment. The score varies from 1 for a single calf vein to 26 for the infrarenal inferior vena cava. The maximum score was 63 per limb. Higher score indicated worse disease prognoses.

ITT population included all enrolled participants for whom EkoSonic® treatment was initiated. Here, 'Overall number of participants analyzed'/'Overall Number of Units Analyzed' signifies the number of participants/units evaluable for this outcome measure and 'Number analyzed' signifies number of limbs/participants analyzed at specified timepoints.

The Ouriel score was designed to provide a more accurate quantitative estimate of the thrombus mass by calculating a volumetric index for all the venous segments. 14 venous segments were considered. Included segments were the inferior vena cava, common iliac veins, external iliac veins, internal iliac veins, common femoral veins, superficial femoral veins, deep femoral veins, and popliteal veins and segments of the anterior tibial veins, posterior tibial veins, and peroneal veins. A normalized volumetric score was calculated for each segment by combining measurements from computed tomography, ultrasonography, and venography. Partially occluded veins were assigned a score of one-half the score value for the segment. The score varies from 1 for a single calf vein to 26 for the infrarenal inferior vena cava. The maximum score was 63 per limb. Higher score indicated worse disease prognoses.

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, 'Number analyzed' signifies number of participants analyzed.

Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease.

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, 'Number analyzed' signifies number of limbs and the number of participants analyzed at specified timepoints.

Limbs with revascularization procedures were considered non-responders. Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease.

ITT population included all enrolled participants for whom EkoSonic® treatment was initiated. Here, 'Overall number of participants analyzed'/'Overall Number of Units Analyzed' signifies the number of participants/units evaluable for this outcome measure and 'Number analyzed' signifies number of limbs/participants analyzed at specified timepoints.

Absence of re-occlusion in following treated veins has been reported: common femoral vein (CFV), common iliac vein (CIV), distal femoral vein (FV), external iliac vein (EIV), popliteal vein, and proximal femoral vein (FV).

ITT population included all enrolled participants for whom EkoSonic® treatment was initiated. Here, 'Overall number of participants analyzed'/'Overall Number of Units Analyzed' signifies the number of participants/units evaluable for this outcome measure and 'Number analyzed' signifies number of limbs/participants analyzed at specified timepoints.

SF- 36 investigates the standard of quality of life through a general health assessment. It is a 36-item questionnaire measuring 8 domains (physical functioning [PF], role physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role emotional [RE], and mental health [MH]). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. The PCS score summarizes the subscales physical functioning, role-physical, bodily pain, and general health. Total score range for PCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, 'Number analyzed' signifies number of limbs and the number of participants analyzed at specified timepoints.

Status of clinical signs and symptoms of lower limb venous disease was measured by CEAP classification. The CEAP clinical Categories were as follows: C0- no visible or palpable signs of venous disease, C1- telangiectasies or reticular veins, C2- varicose veins, C3- edema, C4a- pigmentation and eczema, C4b- lipodermatosclerosis and atrophie blanche, C5- healed venous ulcer, and C6- active venous ulcer. C0 was of the least clinical concern and C6 was the worst stage. Each clinical class was further characterized by the (clinical stages) presence or absence of symptoms (ache, pain, tightness, skin irritation, heaviness, muscle cramps, as well as other complaints attributable to venous dysfunction): asymptomatic and symptomatic.

ITT population included all enrolled participants for whom EkoSonic® treatment was initiated. Here, 'Overall number of participants analyzed'/'Overall Number of Units Analyzed' signifies the number of participants/units evaluable for this outcome measure and 'Number analyzed' signifies number of limbs/participants analyzed at specified timepoints.

The VEINES-QOL/Sym is a participant-based questionnaire designed for self-completion and measures deep vein thrombosis (DVT) impact on symptoms and quality of life from the participants' perspective. It contains 26 items covering participant DVT: symptoms, limitations in daily activities, and psychological impact. A separate summary score VEINES-QOL ranges from 0 (worst quality of life) to 100 (best quality of life). Higher scores indicated a better quality of life.

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.

The VCSS system includes 10 clinical descriptions (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulceration, size of active ulceration, and level of compliance with medical compression therapy), scored from 0 to 3 (total possible score, 30) with 0 = absent, 1 = mild, 2 = moderate and 3 = severe. Total VCSS was the sum of all VCSS assessment scores from categories for a given time point. Total score ranged from 0 (absent) to 30 (severe). Lower values represent a better outcome, that is, a level of pain less than that experienced at baseline.

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, 'Number analyzed' signifies number of limbs and the number of participants analyzed at specified timepoints.

Number of participants with PTS-induced admission to an emergency room or unplanned visits to a physician's office or hospitalization, are reported. A participant can have more than one PTS-induced health issue.

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated.

This Outcome Measure was to measure the time that the participant's initial thrombolytic infusion started to the time the participant was discharged from the hospital.

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated.

Symptomatic PE was diagnosed using computed tomography pulmonary angiogram (CTPA), single positron emission computed tomography (SPECT), and ventilation-perfusion (VQ).

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated.

Number of participants who died due to any cause for up to 365 days following the conclusion of the study procedure, were reported.

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated.