Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it won FDA 510(k) clearance for its Harmonic HD 1000i next-gen ultrasonic surgical shears designed for complex open and laparoscopic procedures.
The newly cleared shears are designed to improve secure seals and function in challenging hemostasis conditions, the Somerville, N.J.-based company said, and are usable across multiple specialties including hepato-pancreato-biliary, thoracic, colorectal and gynecologic oncology procedures.
“Harmonic HD 1000i is the latest example of our commitment to developing meaningful innovations that can help improve outcomes in critical, complex procedures. 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,” Ethicon energy global strategic marketing veep Grace Chung said in a press release.
The Harmonic HD 1000i is designed with a shape that mimics a mechanical dissector, Ethicon said, which reduces the need for separate dedicated dissecting instruments. The hand piece of the Harmonic HD 1000i is integrated into the device as well, the company said.
In April, Ethicon said it closed its purchase of soft-tissue microwave ablation system maker NeuWave Medical for an undisclosed amount.
NeuWave Medical’s ablation technology was developed at the University of Wisconson, Ethicon said. The company’s Certus 140 ablation system allows for single or simultaneous multiple probe procedures in patients with soft tissue lesions.
