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The Circulatory System Devices Panel of the FDA voted 8 to 2 in favor of premarket application approval. The device would be indicated for endovascular repair of the descending thoracic aorta following aneurysm.
Panel member Thomas Ferguson, MD, Washington University School of Medicine, hailed TAG as a giant step forward in the care of patients with aneurysms. Ferguson added that inadequate treatment of the population has long anguished him.
University of Pennsylvania's Henry Edmunds, MD, an exacting critic of the device for much of the meeting, explained his positive vote as common sense overcoming demands for statistical perfection.
Launched in 1999, Gore's 140-patient, non-randomized pivotal study compared TAG with open surgery across 17 U.S. sites. The control group featured an historical arm of 50 patients who already had undergone open surgical repair of aneurysm in the thoracic aorta, as well as 44 patients whose necks were deemed unsuitable for the device.
During the meeting, some panelists asserted that the TAG and open-surgery groups did not constitute comparable populations. Ultimately, the panel recommended that the trial's inclusion, exclusion and anatomical criteria be stated clearly on device labeling.
Following reported stent fractures in 2001, Gore withdrew the first-generation stent-graft from the U.S. market. The privately held firm conducted a second, confirmatory study in 51 patients across 11 sites to assess major adverse events 30 days after treatment.
Gore said the confirmatory study results were in line with the original trial?s findings, and FDA reviewers appeared to agree. Evaluating the proportion of the 140 patients with at least one major adverse event, Gore found 42% for the TAG group versus 77% for the control.
Efficacy, as demonstrated by freedom from a device-related MAE, was 94% in the TAG group, with 100% efficacy assumed for the open-surgical controls.
As a secondary endpoint, Gore concluded that the median length of hospital stay was three days for TAG versus 10 for surgery patients.
Although the panel did not specify how many patients should be enrolled in the recommended postmarket study, the number 300 was floated as a possibility. The panel agreed that the IDE study population also should be evaluated by the same endpoints as the postmarket trial.
The panel did not specify training requirements for TAG implantation, but Gore suggested that implanting physicians should be endovascular surgeons.
From www.fdaadvisorycommittee.com
Panel member Thomas Ferguson, MD, Washington University School of Medicine, hailed TAG as a giant step forward in the care of patients with aneurysms. Ferguson added that inadequate treatment of the population has long anguished him.
University of Pennsylvania's Henry Edmunds, MD, an exacting critic of the device for much of the meeting, explained his positive vote as common sense overcoming demands for statistical perfection.
Launched in 1999, Gore's 140-patient, non-randomized pivotal study compared TAG with open surgery across 17 U.S. sites. The control group featured an historical arm of 50 patients who already had undergone open surgical repair of aneurysm in the thoracic aorta, as well as 44 patients whose necks were deemed unsuitable for the device.
During the meeting, some panelists asserted that the TAG and open-surgery groups did not constitute comparable populations. Ultimately, the panel recommended that the trial's inclusion, exclusion and anatomical criteria be stated clearly on device labeling.
Following reported stent fractures in 2001, Gore withdrew the first-generation stent-graft from the U.S. market. The privately held firm conducted a second, confirmatory study in 51 patients across 11 sites to assess major adverse events 30 days after treatment.
Gore said the confirmatory study results were in line with the original trial?s findings, and FDA reviewers appeared to agree. Evaluating the proportion of the 140 patients with at least one major adverse event, Gore found 42% for the TAG group versus 77% for the control.
Efficacy, as demonstrated by freedom from a device-related MAE, was 94% in the TAG group, with 100% efficacy assumed for the open-surgical controls.
As a secondary endpoint, Gore concluded that the median length of hospital stay was three days for TAG versus 10 for surgery patients.
Although the panel did not specify how many patients should be enrolled in the recommended postmarket study, the number 300 was floated as a possibility. The panel agreed that the IDE study population also should be evaluated by the same endpoints as the postmarket trial.
The panel did not specify training requirements for TAG implantation, but Gore suggested that implanting physicians should be endovascular surgeons.
From www.fdaadvisorycommittee.com
