Medtronic (NYSE:MDT) today released clinical data from a study of its VenaSeal closure system, claiming consistent long-term durability and improved quality of life in patients with venous reflux disease treated with the system
The VenaSeal system from the Fridley, Minn.-based medical giant uses a proprietary medical adhesive to close superficial veins in lower extremities in patients with symptomatic venous reflux, or varicose veins.
To administer the adhesive, an operating physician inserts a catheter through an access site in the leg and guides it, with ultrasound, into diseased veins to administer the VenaSeal adhesive. Along with manual compression, the physician closes the vein so blood is rerouted through other healthy veins in the leg, Medtronic said.
“As shown by our unmatched body of Level 1 evidence in the venous industry, Medtronic has demonstrated its deep-rooted commitment to providing clinically-proven and patient friendly treatment options for patients with chronic venous insufficiency. We’re enthusiastic about the unveiling of such strong datasets, and we look forward to continuing to build upon this clinical program,” endoVenous biz GM Sandra Lesenfants said in a press release.
The data comes from the VeClose pivotal clinical study and 2 subanalysis, as well as 3-year results from the eScope study, Medtronic said. The data was presented at the 2016 Charing Cross Symposium in London.
Data from the VeClose trial indicated long term non-inferiority at 2 years when compared to ClosureFast treatments, with a a 94.3% rate of complete closure of the GSV with the VenaSeal system compared to 94% with the ClosureFast.
A 1-year subanalysis from the VeClose trial also indicated a statistically significant improvement on the Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire and a quality of life improvement across all ages, body mass index, gender and vein diameter size for patients treated with VenaSeal.
“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 post-procedure bruising,” Dr. Kathleen Gibson said in prepared remarks.
A separate analysis of patients treated by physicians with no experience with the VenaSeal indicated that 19 out of 20 of the patients returned for follow ups, with complete GSV closure in 100% of those follow-up patients.
“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,” VeClose principal investigator Dr. Nick Morrison said in a prepared statement.
In a 70-patient, 3-year study of the device, patients showed an 88.5% closure rate at 3 years.
Last year, Medtronic launched the VenaSeal closure system for treating varicose veins in the lower extremities. The device is the 1st and only non-tumescent, non-thermal and non-sclerosant procedure for treating varicose veins in the U.S., Medtronic said.