Halt Medical, Inc. receives FDA clearance for radiofrequency ablation system

Halt Medical Inc., announced it has received clearance from the U.S. Food and Drug Administration for its Halt 2000GI Electrosurgical System for soft tissue ablation using radiofrequency energy.

"This clearance to market is a major milestone for our customers, employees and investors," Russ DeLonzor, Halt president and COO, stated in a company press release.

Radiofrequency Ablation (RFA) with the Halt system is a precise, minimally invasive procedure which uses a slender probe inserted into a tumor under ultrasound guidance. Once in position, 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. RFA therapy is rapidly becoming the treatment of choice among surgeons seeking minimally invasive solutions for relieving debilitating symptoms caused by a variety of diseases such as tumors of the liver, breast, prostate, bone, and kidneys, the company noted.

"The Halt System offers broad advantages over surgery to doctors, their patients, and the health care system," according to Gordon Epstein, MD, Halt Medical chief technology officer. "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 health care system as we replace radical surgery with minimally invasive procedures like Halt RFA will be in the billions of dollars."