FDA grants Microsulis Medical 510(k) clearance for Acculis Accu2i percutaneous microwave tissue ablation system

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."

According to the American Cancer Society, more than 450,000 Americans suffer from lung and liver cancer annually. Historically treatment options for these types of cancer have included one or a combination of treatments including surgical removal of the cancer, chemotherapy, radiofrequency ablation (RFA), or radiation therapy. Ablative therapies which aim to destroy tumors in-situ are limited by the number and size of the tumors that can be targeted and so it's not an option in many cases due to the limited performance of existing RFA and microwave systems. However the Acculis Accu2i pMTA system is the first high power 2.45 GHz system that enables larger and faster ablations to be performed. This means that ablative therapy will now be available as an option for many more patients.

"If the clinical performance of the system confirms the early promise of this technology, this advancement will lead to new treatment options for lung and liver cancer patients," said Dr. William Scott Helton, Chairman, Department of Surgery at Hospital of Saint Raphael, New Haven, Conn. "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."

Source Microsulis Medical Limited