Cryoablation Device Cleared by FDA

A device designed to establish direct access into the prostate gland for faster and easier cryoablation has been cleared by the U.S. Food and Drug Administration (FDA). The device is called the Percutaneous Access Introducer.

Targeted cryoablation is the use of extreme cold in combination with ultrasound and temperature monitoring to precisely destroy cancer cells in and around the prostate gland. Liquified argon gas contained within the tip of a device called a Cryoprobe freezes and destroys the cancer, reaching -40 degrees Celsius. After around 10 minutes, the doctor completes the first freeze cycle, then immediately administers another procedure to help ensure that all cancer cells are killed. The entire procedure lasts about one to two hours.

Targeted cryoablation was developed by Endocare, Inc. (Irvine, CA, USA), which also developed the Percutaneous Access Introducer and the Cryoprobe. The company initially concentrated on developing devices for the treatment of prostate cancer and benign prostate hyperplasia but is now developing cryosurgical technologies for treating tumors in other organs, including the kidney, breast, and liver.

This introducer device benefits the patient by enabling physicians to perform cryosurgery more quickly, with minimal invasion, said Paul Mikus, chairman and CEO of Endocare. It also facilitates the training of physicians for this advanced procedure.