NEWS RELEASE For Immediate Release
TISSUELINK MEDICAL RECEIVES FDA CLEARANCE FOR
THE HEMOSTATIC SEALING AND COAGULATION OF BONE
DOVER, N.H., March 18 — TissueLink Medical Inc., a privately held medical device company, announced that they recently received FDA clearance for TissueLink technology which expands the pre-existing soft tissue indication to include the hemostatic sealing and coagulation of bone.
Dr. Victor Goldberg of The University Hospitals of Cleveland was one of the first orthopaedic surgeons to utilize TissueLink technology. Dr. Goldberg stated: “Blood loss in orthopaedics occurs from both the soft and hard tissue. Bone bleeding in particular has been a problem as no technology has adequately controlled it. In the past we have focused on managing blood loss through strategies such as patient pre-operative donation and cell salvage. Now, TissueLink technology enables us to prevent blood loss. By preventing blood loss we may be able to reduce patient pre-donation requirements, decrease patient exposure to allogenic blood, and reduce post-operative pain, swelling, and hematoma formation. We are in the early stages of a formal clinical study focused on the use of TissueLink technology in arthroplasty.”
Prior to the clinical use of this technology, Dr. Alicia Bertone of The Ohio State University directed pre-clinical studies focused on hemostasis and healing. These studies showed that virtually complete hemostasis was obtained when utilizing TissueLink technology and that healing followed the anticipated, clinically acceptable and uneventful course for soft tissue as well as cancellous and cortical bone.
TissueLink devices incorporate a proprietary technology that uses a fluid to deliver radio-frequency (RF) energy directly to tissue. The fluid controls the temperature at the interface, allowing tissue to seal without burning, charring or perforation. The company first launched its monopolar products in 2001 into General Surgery where they are used in over one-third of all liver resections in the United States today. In August of 2002, the company began clinical use of a bipolar device for soft tissue coagulation. With the addition of the bone sealing clearance, TissueLink offers complete hemostasis at the surgical site.
For more information about TissueLink Medical visit the web site at
www.tissuelink.com, from within the United States call (866) 777-9400, or outside the United States call (603) 742-1515.
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