Medtronic Shares Positive Data on VenaSeal for Leg Ulcers

Medtronic has released primary and secondary outcomes of its VenaSeal Spectrum Venous Leg Ulcer (VLU) Study.

The study assessed time to ulcer healing after VenaSeal treatment in patients with an active venous leg ulcer (classified as C6), as the primary endpoint, and a secondary endpoint of vein closure through 12 months. Results showed evidence that VenaSeal effectively heals venous leg ulcers by treating them at the source of the disease.

The Spectrum VLU data addresses superficial venous insufficiency (SVI) treatment in an understudied, complex patient population. Many factors make C6 patients more complex to treat, including advanced chronological age and high rates of serious comorbidities.

At one year, VenaSeal provided a 81.3% healing rate, 82.7% anatomic closure rate, and 83% freedom from ulcer recurrence. Median ulcer age in the study was 169 days, with maximum age of 18 years and eight months.

Safety events included hypersensitivity to VenaSeal (0.8%), phlebitis (8.8%), granuloma (1.6%), and ablation-related thrombus extension (ARTE) (2.4%). There were eight serious adverse events related to the device or procedure: infections (four), superficial vein thrombosis (three), and granuloma (one).

There was a low hypersensitivity rate of 0.8% and no deaths related to the device or procedure.

“This rigorous clinical data demonstrates that VenaSeal delivers outstanding ulcer healing rates in a challenging subset of patients with advanced superficial venous disease,” said Prof. Manj Gohel, principal investigator of the VenaSeal Spectrum Program, consultant vascular surgeon and honorary senior lecturer, Cambridge University Hospitals, Imperial College. “The evidence should give physicians confidence that VenaSeal is an effective, safe, and appropriate treatment for a range of patients experiencing SVI.”

“This new data from the Spectrum Program expands the body of knowledge showing that VenaSeal is an effective treatment across the full range of superficial venous disease severity,” added David Moeller, senior vice president and president, of Medtronic’s Peripheral Vascular Health business. “It demonstrates that VenaSeal is appropriate and reliable for complex SVI cases, building on the breadth of published data on treatment earlier in the course of the disease.”

Earlier this week, Medtronic revealed several developments:

• FDA approval of its OmniaSure defibrillation lead
• Submission of Hugo surgical robot to FDA and meeting clinical study endpoints
• Positive outcomes from two AFib studies of patients treated with Affera