Results of VeClose study of VenaSeal for treatment of incompetent greater saphenous veins-Medtronic

Medtronic plc 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 US National Principal Investigator, Nick Morrison, MD, at the European Venous Forum 2015 in St. Petersburg, Russia.

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:

1. 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).
2. The closure rate at six months was 98.9% and 94.3% for the VenaSeal closure system and the ClosureFast catheter, respectively.
3. At 12 months, closure rates were identical between the two treatment groups at 96.8%, with no serious adverse events reported.

Comment: The VenaSeal closure system is currently approved in Australia, New Zealand, Canada, Europe, Hong Kong and the United States, and more than 2,000 patients have been treated with the system.