FDA
1st August 2014

FDA Device Panel Recommends Against Approval of Ablatherm

On Wednesday of this week, the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting discussed, made recommendations, and voted on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc (EDAP TMS).

FDA Device Panel Recommends Against Approval of Ablatherm

On Wednesday of this week, the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting discussed, made recommendations, and voted on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc (EDAP TMS).

Ablatherm Integrated Imaging device (Ablatherm) is intended for the primary treatment of prostate cancer in subjects with low risk, localized prostate cancer. The device works by thermally ablating the prostate gland using high-intensity focused ultrasound (HIFU).

Ablatherm has been available in Europe for 15 years. Manufactured by EDAP TMS, a French company, Ablatherm is a computer-controlled device composed of a treatment module, a control console, and an endorectal probe that is inserted rectally while the patient is under general or spinal anesthesia. The probe heats the target tissue to therapeutic levels, thus destroying it. EDAP TMS describes HIFU therapy as a “minimally invasive treatment during which the Ablatherm device precisely focuses ablative energy on the prostate gland while avoiding damage to sensitive adjacent anatomy.”

The Panel voted 8-0, with one abstention, that Ablatherm therapy should not be approved for the proposed indication as the benefits did not outweigh the risks.  Additionally, the panel unanimously voted that there was not reasonable assurance that the device was effective for the proposed indication, and voted 5-3, with one abstention, that there was not reasonable assurance that the device was safe for the proposed indication. Panel members pointed out multiple issues with the pivotal trial’s (ClinicalTrials.gov NCT00295802) data, emphasizing the lack of demonstrated efficacy along with a high rate of severe adverse events (41%) for a supposed noninvasive treatment.

Dr. Eric Kleing, chairman of the Glickman Urological and Kidney Institute, at the Cleveland Clinic noted, “I don’t think the potential benefits outweigh the risk.” Specifically, Dr. Kleing stated that his negative opinion of the device, “relates mostly to the fact that patients with low-risk prostate cancer are at low risk for progression and being harmed by their disease and there are other management strategies that have lower risk than this proposed therapy.”

On Thursday, the second day of the meeting, the panel discussed and made recommendations regarding the classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

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