Covidien gets FDA 510(k) approval for Sonicision cordless ultrasonic dissection device

21 September 2014 (Last Updated September 21st, 2014 18:30)

Irish-based Covidien has received 510(k) approval from the US Food and Drug Administration (FDA) for its Sonicision cordless ultrasonic dissection device with three additional lengths, 13cm, 26cm and 48cm.

Sonovision

Irish-based Covidien has received 510(k) approval from the US Food and Drug Administration (FDA) for its Sonicision cordless ultrasonic dissection device with three additional lengths, 13cm, 26cm and 48cm.

Currently, the 39cm-long Sonicision device can be used in a wide range of general, bariatric, colorectal, gynecological and urological surgical procedures.

Approval for new lengths helps surgeons to use the device in additional procedures such as pediatric colectomy, splenectomy and appendectomy.

Covidien president of advanced surgical Chris Barry said: "Covidien is a pioneer in developing energy-based medical devices and the Sonicision system's groundbreaking cordless technology continues to transform how minimally invasive surgery is performed.

"These new device lengths enable surgeons to use Sonicision technology in a more diverse range of surgical procedures, while avoiding the need for cords and separate generators."

Increased mobility of the cordless ultrasonic dissection device reduces the frustration of managing cords in a sterile field and helps to increase procedural efficiencies.

"These new device lengths enable surgeons to use Sonicision technology in a more diverse range of surgical procedures, while avoiding the need for cords and separate generators."

In addition, reducing the number of cords in the operating room (OR) contributes to a safer OR and patient experience.

The company said that the device's streamlined design allows a surgeon's eyes to remain in the surgical field rather than on the instrument.

In August, Covidien completed the acquisition of a US-based privately held medical device firm Reverse Medical that focuses on solutions for the management of vascular disease, for an undisclosed amount.

The acquisition will help Covidien integrate Reverse Medical business into its neurovascular product line in the medical devices segment.

Reverse Medical is currently commercialising its vascular embolisation plugs, MVP micro vascular plug system and UNO meurovascular embolisation system.


Image: The US FDA cleared three new device shaft lengths in addition to the current 39cm device. Photo: courtesy of Business Wire.