We greatly appreciate the input by Dr. Chandra and colleagues. Our
paper was a highly focused, empiric exercise to determine, based on
morphology alone, the potential for endoluminal implants for treatment of
aneurysms. There are myriad additional factors that, without question,
will affect the appropriateness of such devices for a given aneurysm,
including aneurysm rupture status, patient condition, age, tolerance of
antiplatelet agents, vascular access, and others that will become apparent
as these devices gain widespread use.
We welcome the comments by Dr. Chandra and colleagues regarding the
FDA approval status of the device. Of course, the work performed for
that paper was done long before the device was even submitted for FDA
approval, and represents a "thought experiment" rather than a clinical
trial. We, as they, assume that physicians are capable of reading the
package insert to determine the type of aneurysm for which the device was
specifically approved. We also assume that, as with many or most devices
approved under the Premarket Approval process, actual usage will extend
far beyond the "on-label" indication. We genuinely hope that such "off-
label" usage will be done in the setting of prospective, controlled
studies if at all possible, such studies that in the future might lead to
or away from FDA approval for expanded indications.
David F. Kallmes
Harry J. Cloft
David Fiorella
Conflict of Interest:
None declared
We greatly appreciate the input by Dr. Chandra and colleagues. Our paper was a highly focused, empiric exercise to determine, based on morphology alone, the potential for endoluminal implants for treatment of aneurysms. There are myriad additional factors that, without question, will affect the appropriateness of such devices for a given aneurysm, including aneurysm rupture status, patient condition, age, tolerance of antiplatelet agents, vascular access, and others that will become apparent as these devices gain widespread use.
We welcome the comments by Dr. Chandra and colleagues regarding the FDA approval status of the device. Of course, the work performed for that paper was done long before the device was even submitted for FDA approval, and represents a "thought experiment" rather than a clinical trial. We, as they, assume that physicians are capable of reading the package insert to determine the type of aneurysm for which the device was specifically approved. We also assume that, as with many or most devices approved under the Premarket Approval process, actual usage will extend far beyond the "on-label" indication. We genuinely hope that such "off- label" usage will be done in the setting of prospective, controlled studies if at all possible, such studies that in the future might lead to or away from FDA approval for expanded indications.
David F. Kallmes Harry J. Cloft David Fiorella
Conflict of Interest:
None declared