Ethicon secures FDA clearance for HARMONIC HD 1000i ultrasonic surgical device

5 July 2016 (Last Updated July 5th, 2016 18:30)

US-based medical device firm Ethicon has secured the US Food and Drug (FDA) 510(k) clearance for its HARMONIC HD 1000i ultrasonic surgical device for complex open and laparoscopic procedures.

US-based medical device firm Ethicon has secured the US Food and Drug (FDA) 510(k) clearance for its HARMONIC HD 1000i ultrasonic surgical device for complex open and laparoscopic procedures.

The HARMONIC HD 1000i facilitates precision, unparalleled strength as well as an efficient and easier dissection, faster transection and a secured sealing.

Ethicon energy global strategic marketing vice-president Grace Chung said: "HARMONIC HD 1000i is the latest example of our commitment to developing meaningful innovations that can help improve outcomes in critical, complex procedures.

"The device also offers an increased sealing speed, multi-functionality, and simplified steps to enable optimal efficiency."

"As we move toward the future, HARMONIC HD 1000i will serve as a platform for developing a portfolio of HARMONIC devices focused on solving unmet surgical needs through our in-depth knowledge of tissue and energy sciences to enable surgeons to reach more patients and restore more lives."

Its blade design delivers secured seals and is instrumental in challenging hemostasis conditions.

The device also offers an increased sealing speed, multi-functionality, and simplified steps to enable optimal efficiency.

The shape of Harmonic HD1000i replicates a mechanical dissector which eliminates the need to use a separate dedicated dissecting instrument.

The HARMONIC HD 1000i has a hand piece integrated into the device which enhances the clinical performance while eliminating the need to order, manage, or clean a separate item.

The device can be used in hepato-pancreato-biliary, thoracic, colorectal, and gynecologic oncology which improves surgeons' ability to handle multiple jobs with expert precision and superior performance.