- Prostate Disease Resources
Prostate Disease- Prostate Health Resource
- Active Surveillance
ACTIVE SURVEILLANCE
.jpg)
Older, less healthy patients may elect not to undergo surgery after an initial prostate biopsy, and instead monitor the disease closely by semi-annual PSA and digital rectal exam for men, and an annual prostate biopsy. This monitoring regimen is commonly referred to as “active surveillance.” Some patients may elect radiation or drug treatments, in addition to necessary ongoing active surveillance. The National Cancer Institute estimates that there are approximately 2.7 million men alive who have a history of cancer of the prostate..
Once the initial 510(k) clearance is obtained for a basic mapping and data maintenance claim, we intend to develop more enhanced product features. Future generation systems will require us to obtain additional regulatory approvals or clearances for use of the ProUroScan system for additional prostate related indications and file additional submissions with the FDA to obtain expanded labeling claims. Such regulatory clearances or approvals may require us to perform additional clinical studies. Future generations of the ProUroScan system may also require us to secure rights to additional intellectual property. We believe that one of the potential future applications for the ProUroScan system, assuming we obtain any necessary FDA clearance or approval, will be to allow physicians to monitor changes in the prostate over time.
Digital Prostate Biopsy
The ProUroScan system is designed to produce a digital image of the prostate showing the size and symmetry of the prostate and the location of tissue abnormalities within the prostate. The system creates a digital record of the exam that can be stored and used for comparison to subsequent exams. We believe the ability to digitally store not only the scan results but all of the individual pressure readings taken during the course of the procedure has potential value and may assist the urologist to gain valuable information about changes in the patient’s condition.
Not available for Sale in the United States.
CAUTION – Investigational device. Limited by Federal law to investigational use.
(Click here for more information)