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ABLATHERM FUSION

EDAP-TMS FRANCE · Model EDP 900800 · UDI-DI 03661690000199

PLP Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The system consists of the following main sub-assemblies: Therapy Control Module, Treatment Module, Endorectal Probe, and consumable Ablapak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.Imported diagnostic data can be fused with the real time ultrasound image in order to facilitate the targeting of the ablation volume.

Recalls

Date	Firm	Reason
2017-08-14	Edap Technomed Inc.	The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining dev

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.