• Insightec has announced that its Exablate Prostate focused ultrasound system has been cleared by the US Food and Drug Administration (FDA) to ablate prostate tissue.
  • The ruling enables physicians to use the device to treat prostate disorders like cancer and benign prostatic hyperplasia.
  • The noninvasive procedure is completed in a single session under MR-guidance and targets focal ablation of the abnormal prostate tissue, with the surrounding normal tissue remaining intact.
  • This is the fourth focused ultrasound device approved in the US to treat the prostate.

Key Points

  • Insightec has announced that its Exablate Prostate focused ultrasound system has been cleared by the US Food and Drug Administration (FDA) to ablate prostate tissue.
  • The ruling enables physicians to use the device to treat prostate disorders like cancer and benign prostatic hyperplasia.
  • The noninvasive procedure is completed in a single session under MR-guidance and targets focal ablation of the abnormal prostate tissue, with the surrounding normal tissue remaining intact.
  • This is the fourth focused ultrasound device approved in the US to treat the prostate.

Insightec Vignette Dance 1000Insightec has announced that its Exablate Prostate focused ultrasound system has been cleared by the US Food and Drug Administration (FDA) to ablate prostate tissue.

The noninvasive procedure is completed in a single session under MR-guidance and targets focal ablation of the abnormal prostate tissue, with the surrounding normal tissue remaining intact. In the clinical trial, patients experienced minimal adverse events and low rates of impact on potency and continence.

“Exablate focused ultrasound has been shown to provide effective control of locally confined prostate cancer in select patients based on two-year biopsy outcomes,” said Behfar Ehdaie, MD, MS, a urologic surgeon at Memorial Sloan Kettering Cancer Center, and the trial’s principal investigator. “Precision ablation together with MR imaging and thermal feedback may enable men to consider a tissue-preserving approach and defer or avoid radical therapy.”

This is the fourth prostate device that has earned US FDA approval. In 2015, the FDA approved the first focused ultrasound system, SonaCare Corp’s Sonablate 450, for the ablation of prostate tissue. Three weeks later, EDAP’s Ablatherm Robotic HIFU received approval. Then, in August 2019, Profound Medical’s transurethral TULSA-PRO device earned 510(k) clearance.

It is important to note that all focused ultrasound prostate devices currently approved in the US are indicated for the ablation of prostate tissue. This could be used to address malignant prostate tissue or other prostate conditions like benign prostatic hyperplasia (BPH).

Read Insightec’s Press Release >

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