Microsulis Medical Limited out of Denmead, England has received FDA 510(k) clearance to bring to the US the company’s Acculis Accu2i percutaneous microwave tissue ablation (pMTA) system. The applicator is administered via a 1.8 mm puncture of the skin to deliver microwave energy at 2.45 GHz for coagulation of soft tissue during endoscopic procedures.
Features from the product brochure:
Product
• 1.8mm shaft, ceramic trocar cutting tip
• Internally cooled
• 14cm and 27cm shaft lengths
• 2m cable reach (cooled cable)
• 2.45GHz operating frequency
• Generator powers from 30W to 180W
• Ablation time 0 – 6 minutes (per use)
• Multiple use per patient
Performance
• Up to 5.6cm coagulation zone in 6 minutes at 180W based on ex-vivo tests (nb in-vivo performance may be greater)
• Scaleable near spherical coagulation zones
• Power and time controls for coagulation rate and size
• Real time visualisation with IOUS / CT
Technical
• 1.4cm emitting tip length
• Integrated coolant and microwave supply cable
• High pressure manifold handle with coolant visualisation
• Closed loop sterile saline coolant
• Independent tissue temperature measurement probes
Press release: Microsulis Medical Limited Receives FDA 510(k) Clearance of Accu2i Percutaneous Microwave Tissue Ablation Device…
Product page: pMTA …
