Primary Analysis of the JETi Thrombectomy System for the Treatment of Lower Extremity Deep Vein Thrombosis

Sunday, March 30, 2025

3:00 PM – 3:09 PM CT

Location: Music City Center, 201 AB

Presenting Author(s)

Mahmood Razavi, MD

Interventional Radiologist
Vascular & Interventional Specialists Of Orange County, United States

Purpose: Mechanical thrombectomy is a minimally invasive procedure used to rapidly remove clots in deep vein thrombosis (DVT), effectively restoring blood flow and reducing the risk of long-term complications. The Jet Enhanced Thrombectomy intervention Hydrodynamic Thrombectomy System (JETi System) is a hydro-mechanical aspiration system intended to remove intravascular thrombus. The JETi Registry (JETi Peripheral Thrombectomy Registry NCT04370691) is a prospective, single-arm, multicenter, post-market study designed to collect real-world data on the JETi System. Thirty-day primary endpoint results are reported on use of the JETi System to treat lower extremity (LE) DVT.

Materials and Methods: One hundred and sixteen patients were treated with the JETi System for LE DVT. Primary effectiveness was assessed by the percent of treated vessel(s) with ≥ 75% venous thrombus reduction from the baseline (pre-JETi) to final (after any/all adjunctive therapies) venogram per core lab assessed modified Marder score. Safety was assessed by the composite rate of JETi-related major adverse events that included death, symptomatic pulmonary embolism, major bleeding, and re-thrombosis of JETi-treated vessel(s) up to 30 days post-procedure per clinical events committee adjudication. Key descriptive endpoints include core-lab adjudicated acute success, venous patency and compressibility via duplex ultrasound, the Villalta Post Thrombotic Syndrome (PTS) severity scale, assessment of leg pain, and the Short Form (SF)-12 quality of life assessment.

Results:

The study enrolled an all-comers population with a high rate of prior DVT and risk factors (53.4%), hypertension (45.7%), hyperlipidemia (32.8%), diabetes (24.1%), current or former malignancy (18.9%), and prior peripheral intervention (14.7%). Subjects were on average approximately 57 years old and evenly male and female. Nearly three quarters of the population (74.1%) had onset of signs and symptoms ≤ 14 days, 16.4% were > 14 days but ≤ 42 days, and the remaining (9.5%) > 42 days.

Primary effectiveness, at least 75% reduction in modified Marder Score from pre-JETi venogram to final JETi venogram, was achieved in 84.5% (93/110) limbs. The primary safety endpoint, composite of JETi-related MAEs, was 1.7% (2/116). Treated vessel patency and compressibility, Villalta PTS score, leg pain, and quality of life were all improved at 30 days.

Conclusion: The JETi System is an effective and safe device for the removal of thrombus in LE DVT.