 |
| A model of a procedure that treats uterine fibroids using the VizAblate--Courtesy of Gynesonics |
A minimally invasive device developed by Gynesonics of Redwood City, CA, to treat uterine fibroids by integrating ultrasound imaging and radio frequency ablation has been tested in Germany and could be an alternative to controversial power morcellators.
Called the VizAblate System, the device was recently used on a patient in Cologne, Germany. The procedure is incision-less, preserving the uterus, and doesn't involve laparoscopy or hysteroscopy, the company said. It features the first graphically-based ablation sizing guide and safety margin indicator and can remove larger and deeper fibroids that are not treatable by other transcervical methods.
"This system may produce a paradigm shift in the way patients are treated for symptomatic uterine fibroids," Dr. Ralf Bends, who performed the procedure, said in a statement. "The intrauterine ultrasound imaging made the navigation and radio frequency ablation extremely efficient."
The debut of the VizAblate device comes just weeks before a FDA Medical Device Advisory Committee meeting scheduled for July 10 and 11, to discuss the safety of laparoscopic power morcellator devices used in minimally invasive surgeries to remove uterine fibroids. In April, the agency issued a warning advising against using the devices. It said women undergoing the procedures carried a one in 350 risk of uterine sarcoma, and that power morcellators could worsen the spread of cancerous tissue.
Johnson & Johnson ($JNJ), the largest U.S. maker of power morcellators, suspended sales of the devices after the warning but didn't take them off the market. Intuitive Surgical ($ISRG) responded by cutting 2014 growth projections of its da Vinci surgical robot, citing power morcellator safety concerns as one reason for the lower guidance. Last November, the company issued a recall of 1,300 of its da Vinci device arms.
The FDA, which gave its okay to power morcellators in the 1990s, has only banned an approved medical device once before: artificial hair implants. Prior to the FDA advisory on power morcellators, the device was used in an estimated 50,000 uterine surgeries each year, the Wall Street Journal reported.
- see the Gynesonic release
- check out the WSJ's latest take (sub. req.)