Key Points
- The US FDA has granted an investigational device exemption (IDE) for Insightec to begin a clinical trial comparing its focused ultrasound device to active surveillance in patients with prostate cancer.
- The Exablate Prostate system uses focused ultrasound to ablate target tissue under MRI guidance.
- An earlier clinical trial using the device showed positive results with minimal complications.
Insightec has announced that it has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to begin a clinical comparative study of its Exablate Prostate system.
The clinical trial will evaluate the safety and efficacy of focal treatment using high-intensity focused ultrasound when compared to active surveillance in men living with prostate cancer.
The company’s Exablate Prostate system uses focused ultrasound – under MRI guidance – to noninvasively ablate, or destroy, targeted tissue in the prostate. The single session treatment does not require incisions and allows patients to quickly return to normal activity with minimal complications.
The Insightec Exablate Prostate system received 510(k) FDA clearance in November 2021, and it was used to treat the first US commercial patient the following January.
A previous clinical trial using the Insightec device at Memorial Sloan Kettering Cancer Center reported minimal damage to adjacent structures and low rates of impact on potency and continence, supporting function and quality of life for patients. The new comparative study will build on these data.