Study Supports Benefits of Minimally Invasive Surgery For Chronic Leg Ulcers
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Study Supports Benefits of Minimally Invasive Surgery For Chronic Leg Ulcers

CUPERTINO, CA. -- October 6, 1997 -- A report published in The Journal of Vascular Surgery suggests subfascial endoscopic perforator surgery (SEPS) may be preferable to traditional open surgery for the treatment of venous stasis ulcers.

The study, conducted by the New England Medical Center, used General Surgical Innovations, Inc.’s Spacemaker® balloon. The study, which included 15 patients and follow-up ranging from three to 64 weeks, concluded using the SEPS procedure as part of a treatment plan resulted in a high rate of wound healing, no recurrent ulceration and potential overall cost savings as a result of reduced wound complications and quicker patient recovery time compared to traditional open surgery.

More than four million people worldwide suffer from venous stasis ulcers and, in the United States alone, an estimated 500,000 people each year develop this condition which causes painful, chronic wounds that typically form on the lower calf as a result of chronic venous insufficiency (CVI).

The use of the SEPS procedure eliminates the need for large incisions in the leg, which can take months to heal and provides relatively bloodless access to the incompetent veins. As a result, patients generally experience less trauma during surgery, minimal post-operative pain, less scarring and shorter recovery periods.

The Spacemaker balloon dissection systems can rapidly and atraumatically create surgical working spaces by separating natural tissue planes without resorting to blunt dissections used in conventional open surgery or minimally invasive surgery conducted outside of a natural body cavity. In dissection procedures, the balloon dissection system is inserted uninflated between tissue layers through a small incision. The balloon is then filled to a specific volume with air or saline, causing the desired dissection of the tissue planes. The system is then removed and the dissected space can be insufflated with gas to create a surgical working space.

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