Acoustic Surgery Devices in Clinical Trials

The article by Gail ter Haar presents an excellent review of the history and current status of acoustic surgery, and describes the renewed interest and newest applications of high-intensity focused ultrasound (HIFU). Unfortunately, ter Haar neglects to mention outstanding contributions, dating back more than 30 years, from a group at the Indiana University School of Medicine in Indianapolis.

In 1970, researcher Frank Fry and neurosurgeon Robert Heimburger began treating terminally ill brain-cancer patients with Fry’s HIFU device, which was coupled with a highly accurate B-mode imaging system. ¹ Fry and Heimburger continued to improve the HIFU technology. Then, in consultation with Indiana’s department of urology, Fry and I developed a prostate ablation device ² that combined both imaging and HIFU treatment within a single ceramic crystal, thus eliminating transducer alignment complications. This device was approved in the US and Europe in 1992 for treatment of benign prostatic hyperplasia, ³ and has been used by my company to treat BPH patients for several years. Unlike the “disappointing” results ter Haar mentions, multisite phase-III clinical trials demonstrate that HIFU treatment is safe and effective, improves peak urinary flow, reduces symptom scores, and improves quality of life.