TransEnterix (NYSE:TRXC) said today that it won 510(k) clearance from the FDA for its Senhance Ultrasonic instrument system, designed to operate with its Senhance robot-assisted surgery device.
Senhance Ultrasonic instruments are designed to deliver controlled energy to ligate and divide tissue and minimize thermal injury to surrounding structures, Research Triangle Park, N.C.-based TransEnterix said. The instrument set is now on the market in the U.S. and all countries that recognize the CE Mark, which the company won for Senhance Ultrasonic last October. The U.S. clearance for Senhance covers laparoscopic colorectal, gynecological, inguinal hernia and cholecystectomy procedures, TransEnterix said.
“Advanced energy devices are used within a high percentage of cases across a wide range of procedures, which make them a critical tool for laparoscopic surgeons,” president & CEO Todd Pope said in prepared remarks. “We believe the addition of the Senhance Ultrasonic system is significant and broadens the attractiveness of the Senhance platform and digital laparoscopy for surgeons in the U.S.”
“The addition of ultrasonic technology is a significant expansion of the Senhance system capability preferred by many surgeons during complex procedures,” added Dr. Steven McCarus of the Florida Hospital Celebration Health. “Combining advanced energy tools with the precision, control, haptics and ergonomics of the Senhance digital interface may allow many surgeons to confidently use this technology across the broadest range of pathology and patients.”
Senhance is the only market-cleared competitor for Intuitive Surgical (NSDQ:ISRG) and its da Vinci line of surgical robotics systems, which first won FDA approval in 2000. TransEnterix touts Senhance as the only platform with haptic force feedback, reusable instruments and 3mm instruments.
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