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| William Maisel |
With the FDA approval of Covidien's VenaSeal closure system, medical professionals can for the first time treat varicose veins in the legs by using an adhesive to cut off blood supply. The treatment uses a catheter, delivery system and liquid adhesive that polymerizes into solid to block blood from symptomatic superficial diseased veins in a procedure touted to have quick recovery times.
Unlike varicose vein procedures that use heat application or cutting, "the in-office procedure can allow patients to quickly return to their normal activities, with less bruising," said William Maisel, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, in a release.
Varicose veins occur when veins become weak or damaged, causing blood to back up and pool, often causing the veins to become enlarged, swollen or twisted. Often, the condition causes no symptoms, but some patients can experience pain, blood clots, or skin ulcers, according to the NIH.
The FDA reviewed data from three clinical studies for the basis of its approval decision. A U.S. clinical study assessed the system in 108 participants compared to radio-frequency ablation of 114 participants. Based on the trials, the FDA found the device to be "safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs," it said in a release. All of the product's components must be used as a complete system.
Covidien acquired VenaSeal in August 2014 with its purchase of Sapheon; it announced its merger with Medtronic ($MDT) in June of that year and has since been acquired by the Minneapolis-based devicemaker.
"If left untreated, varicose veins can progress into a chronic and life-threatening condition," Covidien CMO of Vascular Therapies Dr. Mark Turco said in the Sapheon announcement. "The VenaSeal system is a minimally invasive technology, and unlike open surgery and other more invasive procedures, patients are often able to quickly regain their lifestyle."
- here's the release