VenaSeal is a new option for treating varicose veins using an adhesive to effectively “glue” the vein shut. The VenaSeal story began at Inland Imaging in Spokane, Wash., where vascular services manager Monte Madsen worked with Dr. Rod Raabe.
“Dr. Raabe came into the clinic one day and said, ‘Hey, why couldn’t we treat veins with glue?’” Madsen says. “So I had the brilliant response of: ‘I don’t know. Why not?’”
Madsen and Raabe teamed up and formed Sapheon with CEO Don Crawford. Together they brought on engineers, started animal testing and began developing a full-fledged product. Next up was the lengthy approvals process.
VenaSeal was approved in Europe in September 2011 and other countries before the United States in February 2015.
Madsen says that it was difficult at times to raise enough money to pass the rigorous clinical testing required by the U.S. Food and Drug Administration. “This particular product went through what’s called a PMA (pre-market) approval from the FDA,” Madsen says. “It’s treated like an implant because the adhesive we put in there is a permanent implant in the patient, and so it requires a higher level of approval and testing process through the FDA.”
Sapheon was purchased by Covidien, which is now a part of top medical device sales company Medtronic. In the immediate future, Medtronic looks forward to providing this new option to as many patients as possible and eventually for it to be approved by insurance companies.
If you would like to learn more about VenaSeal or believe you are a candidate, please call the Fitzgibbons Vein Center offices or fill out the online consultation request form....