Single Center Post-Market Study of Thrombolytic Therapy Using the Versus™ Catheter

Single Center Post-Market Study of Thrombolytic Therapy Using the Versus™ Catheter

Assess the functionality of the Versus Catheter for catheter-directed thrombolysis of pulmonary blood clots, including advanced imaging assessment. An evaluation of patient outcomes from the cases included in this study will also be conducted.

The objective of this study is to assess the functionality of the Versus™ Catheter for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary artery vasculature in adult patients, including advanced Computerized Tomography Angiogram (CTA) imaging assessment. This study will include an evaluation of patient outcomes and physician user experience with the Versus™ Catheter among up to 10 patients meeting the criteria for enrollment.

Inclusion Criteria:

• Patients 18 - 80 years, inclusive
• Patients who present with submassive pulmonary embolism (PE)
• Patients requiring thrombolytic intervention to the pulmonary vasculature
• Physician decision to use the Versus™ Catheter during the treatment of the patient

Exclusion Criteria:

• Concurrent treatment with thrombectomy
• Concurrent treatment with a catheter-directed thrombolysis device that is NOT the Versus™ Catheter
• Massive pulmonary embolism (PE)
• Active bleeding disorder1
• Recent cerebrovascular accident or transient ischemic attack1
• Recent neurosurgery1
• Recent intracranial trauma1
• Absolute contraindication to anticoagulation1
• BMI > 45kg/m2
• In the opinion of the investigator, the participant is not a suitable candidate for the study