February 20, 2015
Medtronic's VenaSeal Closure System Gains FDA Approval
February 20, 2015—The US Food and Drug Administration has announced the approval of Medtronic plc’s VenaSeal Closure System for the treatment of symptomatic lower extremity varicose veins through endovascular embolization with coaptation.
In a press release from Medtronic on February 24, the company advised that it expects to launch the VenaSeal system in the United States in Spring 2015. The VenaSeal system is currently approved in the United States, Australia, Canada, Europe, and Hong Kong.
According to Medtronic, the VenaSeal procedure is a nontumescent, nonthermal, nonsclerosant procedure that may eliminate the risk of nerve injury that is sometimes associated with certain thermal-based procedures. The procedure is administered without the use of tumescent anesthesia, minimizing the need for multiple needle sticks. Additionally, patients report minimal-to-no bruising postprocedure.
Medtronic stated the VenaSeal procedure is shown to be safe and effective, with consistent results across three clinical trials, including the VeClose pivotal study. The 3-month VeClose findings demonstrated closure rates of 98.9%. Nick Morrison, MD, et al recently published the 3-month data online ahead of print in the Journal of Vascular Surgery. Dr. Morrison, who is from the Morrison Vein Institute in Scottsdale, Arizona, serves as national principal investigator of the VeClose trial.
In Medtronic’s press release, Dr. Morrison commented, “The VenaSeal system is an advanced varicose vein procedure that delivers results that are comparable to current methods. As the patient does not require multiple injections of a local anesthetic (tumescent anesthesia), there is minimal to no bruising and patients are often able to quickly return to normal activities.”
According to the FDA's announcement, the approved sterile kit of the VenaSeal system includes an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips, and syringes. The FDA statement differentiates this closure method from those utilizing drugs, laser, radiofrequency, or skin incisions, describing the approach as the injection of a clear liquid that polymerizes into a solid material, sealing the diseased vein. Proper placement of the catheter is monitored via ultrasound.
The FDA also summarized the approval process and studies supporting VenaSeal, which William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, described as the first system approved to permanently treat varicosities via an adhesive sealant.
“Because the VenaSeal system does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising,” said Dr. Maisel.
The data supporting VenaSeal’s approval as a Class III device included the United States-based VeClose clinical trial, which is evaluating its safety and effectiveness in a 108-patient cohort that was compared to a group of 114 patients who were treated with radiofrequency ablation.
The FDA advises that the system "should not be used in patients who have a known hypersensitivity to the VenaSeal adhesive, acute inflammation of the veins due to blood clots, or acute whole-body infection; adverse events observed in the trial—and generally associated with treatments of this condition—included vein inflammation (phlebitis) and burning or tingling (paresthesia) in the treatment zone."
VenaSeal, originally a Sapheon product before being acquired by Covidien in August 2014, is now part of Medtronic’s venous product line after Medtronic and Covidien finalized their merger in January 2015.