More than thirty million Americans suffer from varicose veins. Because of this, a new breakthrough treatment for this disease is now available throughout the U.S. that offers a minimally invasive, little-to-no pain, no bruising, permanent solution that requires only a band-aid. This procedural treatment is called VenaSeal closure system. This treatment, the first FDA-approved treatment for varicose veins that uses a proprietary medical adhesive, has demonstrated consistent results across three clinical trials.
Dr. Kathleen Gibson, Board Certified Vascular Surgeon and a pioneer of the VenaSeal treatment, and Sandra Lesenfants, Vice President and General Manager of the endoVenous business in Medtronic’s Aortic and Peripheral Vascular division, talked to Brandi Walker about how this treatment works, how was it developed, and how effective has it been for treating varicose veins in patients.
Brandi Walker: How does VenaSeal closure system work?
Kathleen Gibson: The VenaSeal closure system treats symptomatic varicose veins by delivering a small amount of specially formulated medical adhesive into the underlying vein that is the source of the problem. The adhesive closes the vein and blood that was pooling in the varicose veins diverts automatically into other healthy veins. During the procedure, a trained physician fills a syringe with the medical adhesive, which is inserted into a dispensing gun that is attached to a catheter. The catheter is advanced into the diseased vein under ultrasound guidance. The catheter is placed in specific areas along the diseased vein and the clinician conducts a series of trigger pulls to deliver the medical adhesive. Gentle manual compression is applied to the leg during the procedure to assist with vein closure. The patient leaves the clinic with a small adhesive bandage over the access site, and is allowed to return to normal activities immediately.
B.W.: How was it developed?
Sandra Lesenfants: There is a long history of use of medical adhesives in other parts of the body. Dr. Rodney D. Raabe M.D., an interventional radiologist in Spokane, Washington, had treated an arteriovenous malformation in a patient’s brain with a medical adhesive and hypothesized that an adhesive could be used to treat venous reflux disease by gluing shut the diseased saphenous veins causing the symptoms. From there, an idea was born. Dr. Raabe and a team at Sapheon, Inc. (a medical device company that was later acquired by Covidien (now Medtronic)) spent the next five years collecting data and developing the right formulation that would enable physicians to use a durable, yet flexible adhesive to be able to treat superficial venous reflux disease. The result was the VenaSeal closure system, the first and only non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to coapt and close the vein. Once the VenaSeal system was developed, Sapheon worked closely with regulatory agencies to conduct the required clinical trials to determine safety and efficacy of the VenaSeal system and bring the product to markets globally.
B.W.: Who developed this closure system?
S.L.: The VenaSeal system was originally developed by Sapheon, Inc. The company was acquired by Covidien in August 2014, and then became part of Medtronic plc during the Covidien/Medtronic merger.
B.W.: How effective has it been for patients dealing with varicose veins?
K.G.: The VenaSeal closure system has been shown to be effective in three clinical studies, with demonstrated safety and high closure rates
- Closure rates in the first in human trial were 92 percent at 12 and 24 months, respectively.
- Results from the European Sapheon Closure System Observational ProspectivE (eSCOPE) study published in the Journal of Vascular Surgery demonstrate a cumulative closure rate of 92.9 percent and improvement in quality of life scores at 12 months.
- The twelve month results of the VeClose pivotal study demonstrates safety and efficacy of the VenaSeal procedure with demonstrated closure rates of 97.2 percent.
Our patients have been very pleased with the procedure. They are not required to wear compression stockings, and are not restricted in terms of work or exercise. One of the patients we treated last month played tennis the day following her procedure. Although the final results of the procedure can take some time, most patients note improvement in how their leg looks and feels immediately.
B.W.: Where is VenaSeal available?
S.L.: The VenaSeal system is currently available in the U.S., New Zealand, Chile, South Africa, Australia, Canada, Europe, United Arab Emirates, Turkey and Hong Kong.
For more information on VenaSeal closure system, visit http://medtronicendovenous.com/patients/7-2-venaseal-closure-procedure/