Medtronic's VenaSeal Closure System Evaluated in Patients With Venous Reflux Disease

April 28, 2016—Medtronic plc announced new clinical data for the VenaSeal closure system demonstrating consistent long-term durability and improved quality of life in patients with venous reflux disease. The data were presented at the Charing Cross Symposium in London, United Kingdom, and at the International Vein Congress in Miami, Florida.

VenaSeal is a nontumescent, nonthermal, nonsclerosant procedure that uses a proprietary medical adhesive to close superficial veins of the lower extremities, such as the great saphenous vein (GSV), in patients with symptomatic venous reflux.

New 2-year results from the VeClose United States pivotal clinical trial were presented at Charing Cross by Raghu Kolluri, MD, Medical Director of Vascular Medicine at Riverside Methodist Hospital in Columbus, Ohio. Kathleen Gibson, MD, presented the data at the International Vein Congress. Dr. Gibson is with Lake Washington Vascular in Seattle, Washington.

Complete closure of the GSV was achieved at 2 years in 94.3% of patients treated with VenaSeal compared to 94% of patients treated with Medtronic’s ClosureFast, showing similar continued long-term noninferiority outcomes.

Medtronic noted that the VeClose pivotal trial compared the effectiveness of the VenaSeal closure system to the gold standard ClosureFast endovenous radiofrequency ablation procedure. The trial enrolled 242 patients with symptomatic refluxing GSVs. Patients were randomized to undergo treatment with VenaSeal and ClosureFast.

In a separate session presented by Dr. Gibson at Charing Cross, a 1-year subanalysis from the VeClose trial compared quality-of-life improvement factors after treatment with VenaSeal and ClosureFast. Patient improvement was rated on a Venous Clinical Severity Score (VCSS) and an Aberdeen Varicose Vein Questionnaire (AVVQ) that included patients factors such as age (45–65 years), body mass index (25–35), sex, and the diameter size of the GSV.

For patients treated with VenaSeal, the mean change in VCSS and AVVQ at 12 months compared to baseline was statistically significant at -4.02 and -8.8, respectively. Findings showed improvement in VCSS and quality of life across all ages, body mass index, sex, and vein diameter size.

In Medtronic’s announcement, Dr. Gibson commented, “This randomized trial demonstrates VenaSeal's ability to provide a safe and effective treatment for patients with varicose veins. With excellent outcomes at 2 years, VenaSeal offers patients an alternative treatment to traditional therapies for varicose veins, allowing a rapid recovery with minimal downtime and diminished postprocedure bruising.”

Also at Charing Cross, Dr. Kolluri presented a roll-in phase analysis from the VeClose trial. The subset analysis evaluated the safety and effectiveness of 20 patients treated with the VenaSeal closure system by trained physicians with no previous VenaSeal device experience. The roll-in group included the first two patients treated with VenaSeal at 10 enrolling sites; 3-month outcomes were then compared to the randomized patients treated with VenaSeal and ClosureFast.

At 3 months, 19 of the 20 patients returned for follow-up. The investigators found complete closure of the GSV in 100% of these follow-up patients, demonstrating comparable efficacy and safety outcomes to the randomized patients treated with VenaSeal (99%, n = 103) and ClosureFast (95.4%, n = 103).

Nick Morrison, MD, of the Morrison Vein Institute in Scottsdale, Arizona, served as National Principal Investigator of the VeClose trial. In Medtronic’s press release, he stated, “Despite having no prior physician experience with VenaSeal, these data demonstrated remarkable ease of use and a limited learning curve for first-time users as compared to experienced users.”

The eSCOPE study’s 3-year results were presented at Charing Cross by Thomas Proebstle, MD, with the Department of Dermatology at the University Medical Center in Mainz, Germany. Of the 70 patients treated with VenaSeal, results showed an 88.5% closure rate at 3 years, demonstrating durable and consistent outcomes over the long-term.

The European postmarket eSCOPE trial is an international, multicenter, prospective, single-arm, observational evaluation of clinical outcomes of the VenaSeal system, which has received European CE Mark approval.

The VenaSeal system is currently available in the United States, New Zealand, Chile, South Africa, Australia, Canada, Europe, United Arab Emirates, Hong Kong, and Turkey, advised Medtronic.