Medtronic Reports 81.3% One-Year Ulcer Healing Rate with VenaSeal for Venous Leg Ulcers at CX2025

Medtronic Presents 12-Month Study Results of VenaSeal Tissue Adhesive for Treating Venous Leg Ulcers (VLU) at CX2025 ConferenceVenaSeal Spectrum), studies showThe one-year ulcer healing rate reached 81.3%.

VenaSeal SpectrumIs a large-scale post-marketing clinical study, which includes two randomized controlled trials and one single-arm clinical study. The research data disclosed this time comes fromSingle-arm study (Evaluated the ulcer healing time (primary endpoint) and venous closure rate within 12 months (secondary endpoint) in patients with C6 level active venous leg ulcers.

Specific Research Data

• Effectiveness

The ulcer healing rate reached 81.3% one year after treatment, with an anatomical closure rate of 82%, and among healed patients, the non-recurrence rate within one year was 83%.

• Safety

VenaSeal-related events were consistent with previously reported literature, specifically including: hypersensitivity reactions (0.8%), phlebitis (8.8%), granulomas (1.6%), and ablation-related thrombus extension (2.4%). No device- or procedure-related deaths occurred, but eight serious adverse events were reported after treatment, including four cases of infection, three cases of superficial venous thrombosis, and one case of granuloma.

Eight percent of the patients in the study died within one year, and these deaths were not related to the device or surgery.

PI Evaluation

"This is the largest prospective study to date on the treatment of C6 disease with cyanoacrylate, demonstrating excellent healing rates comparable to other studies. The existing evidence strongly supports that this technique should become an essential component of the C6 disease management toolkit."

---Manj Gohel  Cambridge

PI Q&A

In response to the audience's question about the recurrence rate of ulcers, Manj Gohel mentioned that the study included patients with deep venous reflux and obesity, who suffer from venous hypertension due to multiple factors. "In such populations, this recurrence rate is very typical as they are already a high-risk group for ulcer recurrence."

Tissue adhesive has been clinically proven in the treatment of varicose veins in the lower limbs. Although the treatment technology shows effectiveness, the product risk is still significant, and it is not easy to perfect this product. Many companies in China are also imitating it, but currently, no product has been approved. Last year, a company submitted the registration of tissue adhesive (Venous Closure Adhesive), which was ultimately rejected by NMPA (not registered). Domestic companies need to address the safety issues of tissue adhesive to avoid rejection by NMPA in the future.Not registered. Therefore, in terms of safety, we can learn from Medtronic's control methods.

n-Butyl Cyanoacrylate has been used for skin wound closure, arterial embolization, and gastric varices embolization before being applied for the treatment of lower extremity varicose veins. Companies in China have also developed products forEpidermal Wound Closure,Fundus VaricesPlugIntended use of the product, and received NMPA approval for marketing.

VenaSealBesides glue (n-Butyl Cyanoacrylate) In addition, it is equipped with a delivery system. The delivery system ensures safer delivery of the adhesive to the lesion site and occludes the varicose veins.

• Precision

The proprietary catheter is highly visible under ultrasound, allowing for precise glue delivery. The delivery system accurately controls the amount of adhesive, delivering 0.10cc of glue with each trigger pull.

• Aggregation

Upon contact with blood, the glue begins to bond with the intima and applies pressure to close the vein. GlueDesigned to remain permanently in the diseased vein and become encapsulated by chronic fibrosis.

• Viscosity

The viscosity of the adhesive is specifically designed to minimize migration and foreign body embolization.

• Flexibility