Microsulis Medical Limited, the leading company in microwave technology for medical devices, today announced that the U.S. Food and Drug Administration (FDA) has provided the company 510(k) clearance to market the Acculis Accu2i percutaneous microwave tissue ablation (pMTA) system for the coagulation of soft tissue during surgical procedures. This innovative treatment allows physicians to apply precise microwave energy to ablate unwanted tissue masses. The system has already been in use in Europe treating liver and lung tumors via a small 1.8 mm needle puncture of the skin. By providing an alternative to "open surgery" patients avoid the risks associated with longer, more invasive surgical interventions.
“The Accu2i pMTA system allows physicians to deliver precise microwave energy to treat tumors up to 5cm in size in a very short period of time. It will add a significant additional tool into the armamentarium of oncologists, surgeons and radiologists treating patients with this illness.”
"We are delighted to receive this clearance from the FDA and are looking forward to introducing the pMTA product to the U.S. market after seeing its success throughout Europe. Having transferred the product to the manufacturer in Europe we now have a system that we know is market-ready and tested," said Stuart McIntyre, CEO of Microsulis Medical Limited. "Moreover this is the first high power 2.45 GHz system available and sets a new benchmark for such devices."