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| EDAP's Ablatherm system--Courtesy of EDAP TMS SA |
French devicemaker EDAP TMS SA is facing FDA scrutiny over its robotic device for prostate cancer, as regulators questioned the product's safety and efficacy in a new report.
The agency issued an executive summary prior to a July 30 advisory meeting to review the company's Ablatherm device and to discuss its benefits and drawbacks in low-risk patient populations. Regulators took issue with EDAP's product data because the company compared patients from two different studies rather than running a head-to-head trial of the device, Bloomberg reports.
The FDA also found fault with EDAP's measurement of how long patients lived without the disease after treatment, saying that it missed the agency's "gold standard" metric of overall survival. Patients who underwent treatment with Ablatherm had a 1.1% risk of their cancer spreading after 8 years, compared to a 1.4% risk for men who received traditional surgery.
The news casts a dark cloud over EDAP's regulatory plans, as the company strives to obtain coveted FDA approval for its product. Ablatherm comprises a probe connected to a robotic arm that is inserted through the rectum to heat tissue and kill cancer cells. Individuals can undergo treatment as outpatients, and the device would be the first of its kind approved in the U.S. for prostate cancer, EDAP CEO Marc Oczachowski told Bloomberg. Ablatherm is already cleared in Europe and has been used on 40,000 patients worldwide.
EDAP is not the only device outfit developing innovative products for prostate cancer. Last year, Israel's BioProtect touted promising Phase I clinical trial results for its biodegradable balloon to reduce rectal injury in prostate cancer patients undergoing radiation therapy. In October, SonaCare Medical will meet with the FDA to discuss its ultrasound-powered prostate cancer treatment and schedule a vote with the agency's Gastroenterology-Urology Devices Panel.
Diagnostics companies are also making headway in the field, offering tests for the early detection of prostate cancer. In March, Myriad Genetics ($MYGN) celebrated promising study results for its Prolaris prostate cancer molecular diagnostic test. The Utah company said it planned to use the data to win coveted Medicare reimbursement for the test.
- read the Bloomberg article
- here's the FDA report (PDF)