In February 2003, the FDA’s General and Plastic Surgery Devices Advisory Committee met and discussed thermal ablation of lung tumors. Concerns were raised about the safety and adverse event reporting associated with Radio Frequency ablation (RFA) of lung tumors.
Last week, the FDA released a Public Health Notification, specifically warning against lung tumor ablation using RFA.
Pointing to several studies, the statement noted,
“[The] FDA has received reports of patient deaths associated with lung tumor ablation using RF ablation devices…Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities.”
“FDA has cleared many RF ablation devices as tools for general ablation of soft tissue by thermal coagulation necrosis. These devices have also been cleared for certain specific indications, including partial or complete ablation of non-resectable liver lesions and palliation of pain associated with metastatic lesions involving bone. It is important to note that they have not been cleared specifically for lung tumor ablation. Manufacturers of ablation devices cannot legally market them for use in lung tumor ablation because clinical data establishing their safety and effectiveness for this purpose have not been submitted to the agency. This includes promoting their safety and effectiveness in training programs.”
In response to the Public Health Notification, AngioDynamics released a statement noting that none of its RFA probes were used in reports the FDA had mentioned.
The company is developing its own RF technology to treat lung malignancies, the poorly named Rapture (in Protestant-Christian scripture, rapture is the name given to the event during which all Christians living on earth are simultaneously transported to Heaven).
AngioDynamics has conducted a 106 patient clinical trial with Rapture. The trial included patients from Europe, Australia and the U.S. There were no deaths within 30 days of treatment.
I first came across this study back in December, 2004, when RITA Medical Systems (subsequently acquired by AngioDynamics), announced the eighteen month survival statistics of the Rapture lung cancer clinical trials.
106 patients with a total of 186 tumors were treated. RFA was technically feasible in 99% of the patients. Diagnoses included non-small cell lung cancer in 33 patients, metastasis from colorectal adenocarcinoma in 52 patients, and metastasis from other primary malignancy in 15 patients. Cancer specific survival among patients with primary non-small cell lung cancer (n = 33) was 91% at both one year and eighteen months. Cancer specific survival among patients with colorectal metastases to the lung (n = 53) was 88% at one year and 82% at eighteen months.
AngioDynamics expects the Rapture clinical trial results to be published during the first half of 2008.