Halt Medical has received FDA clearance for its 2000GI Electrosurgical System for soft tissue ablation using radiofrequency energy.
Halt Medical said that the system delivers a specified amount of energy to the tissue. The heat generated in the process destroys the tumor, allowing it to be absorbed by the body.
Halt Medical said that RFA therapy is becoming the treatment of choice among surgeons seeking minimally invasive solutions for relieving symptoms caused by a variety of diseases such as tumors of the liver, breast, prostate, bone, and kidneys.
The Halt Fibroid System was recently approved for use in Europe, and is currently being studied for this indication in the US.
Gordon Epstein, chief technology officer, said: “The Halt System offers broad advantages over surgery to doctors, their patients, and the healthcare system. With traditional surgical interventions, layers of healthy tissue are cut through to gain access to the tumor. This leads to complications, significant pain, and long recovery times.
“With RFA, patients typically go home the same day and are back to work much sooner. The direct and indirect savings to the healthcare system as we replace radical surgery with minimally invasive procedures like Halt RFA will be in the billions of dollars.”
Jeffrey Cohen, founder of halt Medical, said: “Receiving clearance by the FDA to market our general use ablation system represents a significant step towards our goal of extending the benefits of RFA to the treatment of uterine fibroids in the US.”