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INVAMED

SCIENCE & PUBLICATIONS

Clinical Evidence Library

Peer-reviewed studies, registries, and publications evaluating INVAMED technologies — presented with verified data only, linked to their original sources.

Clinical evidence is the foundation of responsible medical technology. INVAMED supports independent, peer-reviewed research evaluating the safety and effectiveness of its technologies, and works with clinical investigators worldwide to expand the evidence base for minimally invasive care.

Selected peer-reviewed publications

VenaBlock venous closure system

  • Comparative analysis of VenaBlock and VenaSeal systems for catheter-guided endovenous cyanoacrylate closure in treating chronic venous insufficiency of the lower extremity: effectiveness and feasibility.
    International Angiology. doi:10.23736/S0392-9590.24.05143-5
    A systematic comparison including 1,882 extremities from 11 VenaBlock studies, reporting cumulative recanalization-free survival at 6 to 60 months and improvements in venous clinical severity and quality-of-life scores.
  • Registry to investigate the efficacy and safety of the VenaBlock vein sealing system for varicose veins in Singapore — six-month results of the RIVIERA trial.
    Linn YL, Yap CJQ, Soon SXY, et al. Phlebology. 2021;36(10):816-826. doi:10.1177/02683555211025181
    A prospective registry evaluating procedural success, closure rates, and safety outcomes of cyanoacrylate closure in an Asian patient population.

Our approach to evidence

INVAMED views post-market clinical follow-up and investigator-initiated research as continuous obligations, not one-time milestones. The company supports registry participation, comparative studies, and long-term outcome reporting across its vascular, orthopedic, and surgical portfolios, and makes study information available to healthcare professionals on request.

For investigators

Clinicians and research institutions interested in collaborative studies, registry participation, or access to technical documentation for research purposes can reach the INVAMED Medical Affairs team through our contact page.

Additional publications indexed on PubMed provide further independent evaluation of these technologies. This page is updated as new peer-reviewed data becomes available.

Case seriesAortic Aneurysm2025

Multilayer flow modulator stents in aortic aneurysms: an overview based on preliminary experience with the Stena MFM

12 patients underwent aortic aneurysm repair with the Stena Multilayer Flow Modulator (July-December 2022) with 6-month CT angiography follow-up.

Cirugia y Cirujanosn = 12Technical success; aneurysm sac thrombosis; branch vessel patency; sac volume change at 6 months

Technical success 100% with no immediate re-intervention. Complete aneurysm sac thrombosis in all patients at 6 months with preserved main-lumen and branch patency; mean sac volume change -2.36%. No rupture, migration, retraction, thrombosis, or fracture observed.

Systematic reviewVaricose Veins / Chronic Venous Insufficiency2024

Comparative analysis of VenaBlock and VenaSeal systems for endovenous cyanoacrylate closure in chronic venous insufficiency

Literature-based comparative effectiveness analysis of the two most widely used cyanoacrylate closure systems.

International Angiologyn = 2406Cumulative recanalization-free survival at 6-60 months; VCSS; quality-of-life scores

Across 1,882 extremities (11 VenaBlock studies) and 524 extremities (8 VenaSeal studies), cumulative recanalization-free survival was similar between systems (p=0.188); both significantly improved VCSS and QoL scores.

ReviewAortic Aneurysm2024

Role of multilayer flow modulator stents in the treatment of arterial aneurysms

Narrative review of multilayer flow modulator technology for arterial aneurysms covering device rationale, hemodynamic mechanism, and published outcomes.

Therapeutic Advances in Cardiovascular DiseaseTechnical success; aneurysm thrombosis and shrinkage; branch vessel patency (across included studies)

Review of published MFM experience, including the Stena MFM, reporting favorable technical success, progressive aneurysm sac thrombosis, and side-branch patency compared with conventional EVAR limitations in branch preservation.

Prospective cohortPeripheral Arterial Disease2021

Early outcomes of the novel Temren atherectomy device combined with drug-coated balloon angioplasty for femoropopliteal lesions

Single-center prospective study evaluating Temren rotational atherectomy with adjunctive DCB angioplasty in femoropopliteal occlusive disease.

VascularPrimary patency; freedom from target lesion revascularization (TLR); complication rate

Combined use of Temren rotational atherectomy with adjunctive drug-coated balloon angioplasty was reported as safe and effective, with high rates of primary patency and freedom from TLR and low complication rates in femoropopliteal lesions.

Prospective single-center trialPeripheral Arterial Disease2018

LEO 7: Safety and effectiveness of the novel Temren atherectomy system combined with Extender drug-eluting balloon in lower extremity arteries

67 patients / 74 infrainguinal lesions treated with Temren atherectomy plus Extender drug-eluting balloon between 2017-2018.

Journal of Vascular Surgery (abstract)n = 67Technical success (residual stenosis <50% before adjunctive therapy); 30-day major adverse events (MAE); 6-month freedom from TLR/TVR

Lesion technical success 97.0% (target 86%). MAE 8.9% through 30 days and 12% through 6 months. Six-month freedom from TLR 89.0% and from TVR 85.3%. Rutherford class improved in 73% of patients at 30 days and 81% at 6 months.

Retrospective cohortVaricose Veins / Chronic Venous Insufficiency2018

A new n-butyl-2-cyanoacrylate glue ablation catheter with application guiding light for venous insufficiency: twelve-month results

538 patients with great saphenous vein incompetence treated with the VenaBlock n-butyl-2-cyanoacrylate closure system without tumescent anesthesia or compression stockings.

Vascularn = 538Procedural success; occlusion rate at 12 months; VCSS; Aberdeen Varicose Vein Questionnaire (AVVQ)

Procedural success 100%; Kaplan-Meier occlusion rate 99.4% at 12 months. VCSS decreased from 5.43 to 0.6 and AVVQ from 18.32 to 4.61 (p<0.0001). No skin pigmentation, paresthesia, DVT, or PE observed.

Every figure in this library is entered from a verifiable published source by the INVAMED Medical Affairs team. Entries awaiting source verification are marked and exclude all numeric data until confirmed. Device availability and regulatory status vary by country.