SonaCare lands a date with the FDA for prostate cancer therapy
Ablation devices maker SonaCare Medical lands a meeting to review its ultrasound-based prostate cancer ablation device with an FDA panel that just shot down similar device. North Carolina-based SonaCare Medical is getting a day with the FDA, but the company's prospects are murky given that it's going before an advisory panel that just rejected a technology similar to SonaCare's Sonablate 450 prostate cancer therapy. SonaCare MedicalNews Well, Ablation, Food &Drug Administration (FDA), Pre-Market Approval (PMA), Prostate, Regulatory/Compliance, Urologyread more
CONCLUSIONS: Targeted MRI/TRUS fusion-guided focal HIFU allows local tumor ablation, but is not free from limitations. The procedure has good functional outcomes and a quick recovery. Multicenter trials with more patients are required to determine the procedure´s role in the prostate cancer therapy algorithm. PMID: 30093211 [PubMed - as supplied by publisher]
Conditions: Prostate Cancer; Prostate Adenocarcinoma; Transrectal High Intensity Focused Ultrasound Intervention: Device: HIFU Sponsor: Hospital de Transplante Doutor Euryclides de Jesus Zerbini Not yet recruiting - verified August 2017
AbstractPurpose of ReviewProstate cancer is one of the most prevalent malignancies in males and treatment is not infrequently associated with substantial morbidity. As a result, there has been growing interest in alternative therapies for prostate cancer therapy including high-intensity focused ultrasound (HIFU) and focal cryoablation. Herein, we review the potential genitourinary sequelae of these therapies including incontinence and erectile dysfunction.Recent FindingsVarious studies have demonstrated that with improvements in delivery technique and technologies aimed at treatment of prostate cancer, the risks of urinary...
The technology 'fuses' an MRI (magnetic resonance imaging) scanner with ultrasound to identify diseased cells. A precisely targeted laser fibre is then heated up to annihilate them.
ObjectivesTo evaluate longitudinal changes in urinary function and quality of life, and the oncological outcomes of patients treated with urethra‐sparing high‐intensity focused ultrasound for localized prostate cancer. MethodsPatients with negative findings in the urethra and the anterior urethral zone using transrectal ultrasound‐guided targeted biopsies, and magnetic resonance imaging, received urethra‐sparing or whole‐gland high‐intensity focused ultrasound as the primary therapy for localized prostate cancer without transurethral resection of the prostate. Longitudinal changes in urinary function and qualit...