Cleaner VAC ICER-Argon Medical Devices

 Summary of ICER Findings for CleanerVac

This analysis evaluates the long-term cost-effectiveness of using CleanerVac for symptomatic iliofemoral and proximal DVT compared with standard anticoagulation alone. The model also compares CleanerVac’s economic performance to two major thrombectomy competitors; ClotTriever and Penumbra Lightning, using a consistent clinical-effectiveness framework and cost structure. The goal is to understand the long-term value of thrombectomy and quantify where CleanerVac differentiates economically.

Model Structure and Population
The analysis uses a 17-year Markov model reflecting the average age of patients treated in the CleanerVac real-world dataset. Patients transition into one of three health states, no post-thrombotic syndrome (PTS), mild–moderate PTS, or severe PTS, based on expected long-term outcomes after either standard care or mechanical thrombectomy. Costs and quality-adjusted life years (QALYs) are discounted at 3% annually, reflecting standard U.S. health-economic practice.

Clinical Inputs
CleanerVac’s clinical performance is drawn from a 110-patient retrospective multicenter dataset showing high thrombus clearance (~85% mean; 75.5% achieving ≥90% clearance) with low blood loss and no device-related major adverse events. Thirty-patient subset data demonstrated similar high clearance and short procedure times.
Because long-term, device-specific PTS data are not yet available for any platform, the model uses a conservative, class-based effect for mechanical thrombectomy: an approximate 30% relative reduction in PTS incidence and severity versus anticoagulation alone. This is the primary clinical driver of long-term QALY gains and cost savings.

Economic Inputs
CleanerVac’s index cost is modeled using an ASP of $7,500 and zero capital burden. When including expected program efficiencies,portfolio bundling, reduced ward days, fewer readmissions—the effective per-case cost is reduced by approximately $900. Competitor devices are modeled with higher index costs due to higher ASPs and, for Lightning, capital amortization.
Downstream PTS costs follow established literature: mild–moderate PTS generates ~$1,678 in year one and ~$682 annually thereafter, while severe PTS generates ~$7,634 in year one and ~$6,590 annually.

Results vs Standard Care
CleanerVac produces a discounted QALY gain of 0.181 per patient and reduces long-term PTS-related spending by approximately $3,788. After factoring in the incremental up-front procedure cost, the resulting incremental cost-effectiveness ratio (ICER) is approximately $59,735 per QALY, placing CleanerVac well within commonly accepted U.S. cost-effectiveness thresholds ($50,000–$150,000 per QALY).

Comparisons with ClotTriever and Lightning
The model applies the same conservative clinical benefit assumption to all thrombectomy devices, isolating the cost differences. CleanerVac demonstrates the most favorable economic position primarily due to:
• lower per-case index cost
• no capital requirement
• additional efficiency savings that compound at the program level
When applied across 100 annual cases, CleanerVac generates a significantly lower total budget impact than either competitor, primarily driven by ASP and the absence of capital expense.

Sensitivity and Robustness
The results are most sensitive to three variables: (1) the magnitude of PTS reduction after thrombectomy, (2) the index procedure cost, and (3) the time horizon. Across tested ranges (20–40% PTS reduction), CleanerVac remained the most economically favorable option due to its lower cost base. Probabilistic modeling indicates a high probability (>90%) of CleanerVac remaining below a $100,000/QALY threshold.

Conclusion
The ICER modeling indicates that CleanerVac is cost-effective versus standard care and economically superior to competing thrombectomy systems when clinical effects are held constant. Its lower device cost, absence of capital expenditure, and additional program efficiencies create a consistent advantage across payer and hospital perspectives. This positions CleanerVac as the most economically attractive thrombectomy option in the current market while preserving clinical value consistent with mechanical thrombectomy as a class.