Medtronic has announced the twelve-month results of the VeClose pivotal study, which demonstrated the safety and effectiveness of the VenaSeal closure system for the treatment of incompetent greater saphenous veins with a 96.8% closure rate. The results were presented by national principal investigator, Nick Morrison, Morrison Vein Institute, Scottsdale, USA, at the European Venous Forum 2015 (2–4 July, St Petersburg, Russia).
The VenaSeal closure system is a minimally invasive, non-tumescent, non-thermal and non-sclerosant procedure that uses an advanced medical adhesive to close the diseased vein in patients with symptomatic venous reflux disease. Medtronic says that, unlike other treatments, the VenaSeal closure system does not require tumescent anaesthesia, allowing patients to return to their normal activities following the procedure. The VenaSeal procedure also eliminates the risk of nerve or other heat-related injury associated with thermal-based procedures, and may reduce the need for compression stockings post-procedure.
“The VenaSeal closure system provides patients with a minimally invasive procedure that eliminates the need for surgery, thermal ablation and tumescent anaesthesia. As a result, patients are often able to quickly return to normal activities after the procedure,” said Nick Morrison. “The results show sustained closure with VenaSeal closure system that is comparable to closure rates with radiofrequency at 12 months.”
The 12-month results of the VeClose study demonstrated outcomes for the VenaSeal closure system comparable with the closure rates associated with the ClosureFast catheter and demonstrated non-inferiority of the VenaSeal closure system:
- At three months, the complete closure of the great saphenous veins achieved in more than 98.9% of patients treated with the VenaSeal closure system compared to 95.4% of patients treated with the ClosureFast catheter, showing non-inferiority of VenaSeal (p<.0001).
- The closure rate at six months was 98.9% and 94.3% for the VenaSeal closure system and the ClosureFast catheter, respectively.
- At 12 months, closure rates were identical between the two treatment groups at 96.8%.
- Additionally, no serious adverse events were reported.
“The 12-month results of the VeClose trial demonstrates the durability of the system,” said Mark Turco, medical director, Aortic and Peripheral Vascular, Medtronic. “This, combined with the improved patient comfort and reduced recovery times of the VenaSeal closure system, makes this a clinically-proven, patient-friendly treatment option for patients.”
The VenaSeal system is currently approved in Australia, New Zealand, Canada, Europe, Hong Kong, and the USA, and more than 2,000 patients have been treated with the system.