Medtronic (NYSE:MDT) today released five-year results from the VeClose extension study of its VenaSeal closure system, touting durable and consistent long-term outcomes with the system when used to treat patients with chronic venous disease.
The VenaSeal device is a medical adhesive designed to close off the great saphenous vein for treating chronic venous insufficiency and varicose veins.
Results from the trial were presented at the 2019 Charing Cross Symposium in London by Dr. Nick Morrison of the Mesa, Ariz.-based Center for Vein Restoration.
Fridley, Minn.-based Medtronic said that the VeClose extension study was a follow-on study looking to evaluate long-term outcomes at five years post-treatment with the VenaSeal system, which included data from 47 randomized subjects and nine roll-in subjects.
Results from the trial indicate a 94.6% rate of closure of the great saphenous vein at five years, Medtronic said.
“The five-year data support the safety, effectiveness, and quality of life-enhancing capability of both VenaSeal and ClosureFast in treating patients with chronic venous disease. Furthermore, the data demonstrate long-term, strong, and consistent outcomes. The industry will benefit from long-term data like this so that physicians and patients can be confident in their treatment choice,” Dr. Morrison said in a prepared statement.
In the original study, patients were randomized to treatment with either the VenaSeal system or with Medtronic’s ClosureFast radiofrequency ablation device.
Using a Kaplan-Meier analysis of randomized subjects to analyze success over the life of the five-year extended study, investigators reported a 91.4% vein closure estimate for the VenaSeal versus an 85.2% for the RFA.
Patient improvement in the trial was judged based on assessments including the Venous Clinical Severity Score (VCSS), the Aberdeen Varicose Vein Questionnaire (AVVQ) and the EQ-5D. The VCSS is a clinical venous disease assessment, while the other two assessments provide quality of life outcomes.
Five-year data from the trial indicates that subjects sustained or maintained quality of life improvements after treatment with both the VenaSeal or RFA.
“The Medtronic commitment to long-term clinical evidence and improving patient outcomes is underscored by the release of this five-year VeClose extension study data. VenaSeal has already been used in more than 100,000 procedures and that number is growing daily. We want to continue to expand minimally invasive innovation to improve the quality of life for all patients with venous disease,” endovenous biz GM Sandra Lesenfants said in a press release.
Medtronic won FDA premarket approval for the device, which was originally developed by Covidien, in February of 2015.
