Inari’s ClotTriever Studied in Real-World CLOUT Registry of DVT Patients

June 7, 2021—Inari Medical, Inc. announced interim results of the first 250 deep vein thrombosis (DVT) patients enrolled in the prospective CLOUT registry.

According to Inari, the CLOUT data showed that mechanical thrombectomy with the company’s ClotTriever removed 100% of the blood clots in the majority of DVT patients without the need for thrombolytic drugs in short single-session procedures.

The late-breaking data was presented virtually by CLOUT Principal Investigator Robert Beasley, MD, at NCVH 2021, the New Cardiovascular Horizons annual meeting held June 1-4 both virtually and in New Orleans, Louisiana.

The company noted that use of thrombolytics was completely avoided in all 250 patients across the 24 registry sites. Median blood loss was a modest 50 mL, with a short median thrombectomy procedure time of 28 minutes.

“CLOUT has shown us that by getting between the vessel wall and the thrombus, ClotTriever can remove all of the clot without any injury to the vein or its valves, restoring normal blood flow and valve function,” commented Dr. Beasley in Inari’s press release. “For patients with acute, subacute, and chronic clot, ClotTriever has offered long-term relief from the pain associated with DVT and a return to normal life, free from the debilitating symptoms of postthrombotic syndrome.” Dr. Beasley is an interventional radiologist at Palm Vascular Center in Miami, Florida.

The ClotTriever system has received FDA 510(k) clearance and European CE Mark approval for the treatment of DVT.

In September 2018, Inari announced enrollment of the first patient in the real-world, prospective, multicenter, single-arm CLOUT registry, which is expected to enroll a total of 500 patients.

The company announced in January that interim results of the first 64 patients enrolled in CLOUT were presented virtually by Principal Investigator Steven Abramowitz, MD, at LINC 2021, the Leipzig Interventional Course held January 25-29. The subanalysis, which focused on patients with an estimated clot age over 6 weeks, found no serious device-related adverse events across the 14 subanalysis sites; additionally, median blood loss was 50 mL, and median thrombectomy procedure time was 34 minutes.