12 November 2015 | News | By BioSpectrum Bureau
Medtronic launches VenaSeal Closure System
The VenaSeal Closure System (Photo courtesy: Medtronic)
Medtronic has announced the US availability of the VenaSeal closure system, the first and only non-tumescent, non-thermal, non-sclerosant procedure approved for the treatment of symptomatic venous reflux in the US. The VenaSeal closure system was approved through the FDA's Pre-Market Approval (PMA) process, and is a minimally invasive procedure that uses a proprietary medical adhesive to close superficial veins of the lower extremities, such as the great saphenous vein, in patients with symptomatic venous reflux.
Using ultrasound, the physician guides a catheter through a small access site in the leg and into the diseased area of the vein. Once in place, the physician administers the VenaSeal adhesive at various points in a segmental fashion, and with manual compression, closes the vein. Blood is re-routed through other healthy veins in the leg.
This unique approach eliminates the risk of burning or nerve injury that is sometimes associated with thermal-based procedures. The procedure is administered without the use of tumescent anesthesia, minimizing the need for multiple needle sticks. In the VeClose trial, patients reported minimal - to - no pain or bruising, post procedure.
"Medtronic today furthers our commitment to providing treatment options for patients with symptomatic venous reflux, a disease that can significantly impact quality of life," said Ms Sandra Lesenfants, vice president and general manager of the endoVenous business in Medtronic's Aortic and Peripheral Vascular division. "Thousands of patients have benefited from this procedure around the world, and we are pleased to now offer this advanced technology as an option to our U.S. physicians and patients."
The VenaSeal system is currently available in the USA, New Zealand, Chile, South Africa, Australia, Canada, Europe, United Arab Emirates and Hong Kong.