RF Surgical Systems, Inc. Receives FDA Approval To Market Its Blair-Port Wand® As A Reusable Scanning Device

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 15 Oct 2008 - 5:00 PDT

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RF Surgical Systems, Inc., the developer of the RF Surgical Detection System, has received approval from the U.S. Food and Drug Administration to market its Blair-Port Wand as a reusable scanning devise with a 24-hour activation lifecycle in the OR. The announcement was made today at the American College of Surgeons 94th Clinical Congress in San Francisco, CA.

The Blair-Port Wand is a critical component of the company's patented and FDA-approved surgical sponge detection system. Prior to beginning closing procedures, a surgical patient is scanned with the wand. If any RFDetect™ tagged surgical sponges, gauze or towels remain in the patient, a signal will alert the surgical team and allow them to remove the retained sponge. Retained surgical sponges are one of the leading patient safety concerns in hospitals - occurring at an estimated rate of 1 in every 1,000 to 1,500 intra-abdominal surgeries, according to a study in the New England Journal of Medicine.

"We are pleased to provide hospitals with an additional incentive to adopt the RF Surgical Detection System in their operating rooms," said Gary Blackbourn, V.P. Sales and Marketing. "The enhanced viability of the Blair-Port Wand allows it to be reused for multiple surgical cases over a 24-hour lifecycle while maintaining accurate detection and scanning range, even in high BMI patients. The $50 cost of our scanning wand can now be prorated across multiple surgical cases. Given that RFDetect tagged sponges are less expensive than those used by competitive counting systems and that our RF Surgical Detection Consoles are provided free of charge, the RF Surgical Detection System offers even more clear-cut advantages to hospitals in terms of cost, accuracy and ease-of-use."

The RF Surgical Detection System has been adopted by over 40 medical centers and hospitals nationwide and has been used to detect and prevent retained surgical sponges in more than 50,000 surgical cases.

About RF Surgical Systems, Inc.

RF Surgical Systems is a privately held medical device company headquartered in Bellevue, Washington and maintains engineering R & D facilities in San Diego, California. The concept for the RF Surgical Detection System was developed by Dr. Jeffrey Port, a Thoracic Surgeon, and Mr. William Blair, an Electrical Engineer. The system was the first FDA-approved surgical sponge detection system on the market. For more information, please visit www.rfsurg.com.