TransEnterix (NYSE:TRXC) said today that it won CE Mark approval in the European Union for the Senhance Ultrasonic instrument system, designed to operate with its Senhance robot-assisted surgery device.
The Research Triangle Park, N.C.-based company said the ultrasound instruments, designed to deliver controlled energy to ligate and divide tissue and minimize thermal injury to surrounding structures, can be used in a variety of surgeries. Last month TransEnterix filed for 510(k) clearance from the FDA for the Senhance Ultrasonic instrument package, a few months after submitting a separate 510(k) bid for other instruments, including 3mm-diameter devices. Senhance is cleared for laparoscopic colorectal, gynecologic, inguinal hernia and cholecystectomy surgeries.
“Advanced energy devices are an important tool for laparoscopic surgeons because of their applicability within a wide range of procedures,” CEO Todd Pope said in prepared remarks. “We believe the addition of the Senhance Ultrasonic will help drive broader penetration of Senhance and help advance digital laparoscopy in Europe and other countries that accept CE Mark around the world.”
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“Ultrasonic energy devices are critical tools in managing complex surgeries while minimizing bleeding and trauma to surrounding tissue,” added Dr. Dietmar Stephan of Siegen, Germany’s St. Marien Hospital. “In certain procedures, use of such advanced energy has become standard of care. The addition of this capability to the Senhance Digital Laparoscopic platform is a significant expansion of clinical applicability.”
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