Inari Medical, a privately held venture backed medical device company engaged in the development of catheter-based technologies to treat venous thromboembolism (VTE), has enrolled the first patient in the ClotTriever Outcomes Registry (CLOUT) using the ClotTriever thrombectomy system.
CLOUT is a 500-patient prospective, multicenter, single-arm registry to evaluate real world outcomes after treatment of patients with thrombosis in the deep veins of the lower extremity with ClotTriever.
Dr. William Marston, Chief of Vascular Surgery, University of North Carolina and Dr. Robert Beasley, Section Chief, Vascular and Interventional Radiology, Mount Sinai Medical Center, are Co-Principal Investigators.
St. John Oakland Hospital cardiology medical director Dr Herman Kado said: “We are pleased to be the first site to enroll a patient in the CLOUT registry.
“In our experience, the ClotTriever System consistently and efficiently removes iliofemoral clot, allowing us to complete treatment in a single session without the need for thrombolytic drugs or the consequent ICU stay. We’re excited to help evaluate outcomes in a formal study.”
“ClotTriever is an important new tool for venous thrombus,” said Dr. Marston. “The acute outcomes measures will allow us to evaluate the safety profile of ClotTriever as a single session non-thrombolytic option. The two-year follow-up will allow us to determine if significant clot removal improves symptoms and outcomes over the longer term.”
Inari CEO Bill Hoffman said: “CLOUT reflects Inari’s commitment to VTE patients, to large volume clot removal from large veins, and to production of clinical data to help advance the understanding and treatment of the disease.
“We look forward to working with a dedicated group of physician investigators to execute this important study.”
The ClotTriever system is designed to remove large clot volume from large veins via access sites as small as 6 mm. The ClotTriever does not require use of thrombolytic drugs, which carry significant risk of bleeding and are contraindicated in many patients.
The ClotTriever Thrombectomy System is 510(k) cleared for the non-surgical removal of thrombus (blood clots) from the peripheral vasculature.
Source: Company Press Release