Medtronic Reports 12-Month VeClose Pivotal Trial Data for the VenaSeal Closure System

July 2, 2015—Medtronic plc announced that the 12-month results of the VeClose pivotal study demonstrated the safety and effectiveness of the VenaSeal closure system for the treatment of incompetent greater saphenous veins with a 96.8% closure rate. National Principal Investigator, Nick Morrison, MD, presented the data 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 Medtronic’s ClosureFast catheter and demonstrated the noninferiority of the VenaSeal closure system.

Dr. Morrison, of the Morrison Vein Institute in Scottsdale, Arizona, commented in the company’s press release, “The VenaSeal closure system provides patients with a minimally invasive procedure that eliminates the need for surgery, thermal ablation, and tumescent anesthesia. As a result, patients are often able to quickly return to normal activities after the procedure. The results show sustained closure with VenaSeal closure system that is comparable to closure rates with radiofrequency at 12 months.”

Medtronic reported:

• At 3 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 noninferiority of VenaSeal (P < .0001).
• At 6 months, the closure rate was 98.9% for the VenaSeal closure system versus 94.3% for the ClosureFast catheter. 
• At 12 months, closure rates were identical between the two treatment groups at 96.8%.
• No serious adverse events were reported.  

According to the company, the VeClose United States pivotal clinical trial was designed as a prospective, randomized, controlled, noninferiority study that compared the safety and effectiveness of the VenaSeal closure system to that of the ClosureFast endovenous radiofrequency ablation catheter, which is designed to collapse and close enlarged leg veins. The trial enrolled 222 patients with symptomatic refluxing great saphenous veins, randomizing 108 patients to receive treatment with the VenaSeal closure system and 114 patients with the ClosureFast catheter.

The VenaSeal closure system uses an advanced medical adhesive to close the diseased vein in patients with symptomatic venous reflux disease. The VenaSeal closure system does not require tumescent anesthesia, 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, stated Medtronic.

VenaSeal was developed by Sapheon, Inc., which was acquired by Covidien in August 2014. Covidien was acquired by Medtronic in January 2015. On February 20, Medtronic announced US Food and Drug Administration approval of the VenaSeal system for the treatment of symptomatic lower extremity varicose veins through endovascular embolization with coaptation. The VenaSeal closure system is currently approved in Australia, New Zealand, Canada, Europe, Hong Kong, and the United States.