and Irene Sarosiek at the University of Kansas Medical Center
...McCallum, a board-certified gastroenterologist, is the director of the center for the gastrointestinal nerve and muscle function at KUMC.
led a double-blind, placebo controlled study which led the FDA
to approve the gastric stimulator device made by Medtronic
in 2000 for humanitarian reasons.
Informing Coventry that the stimulator "has become a generally accepted treatment among practicing physicians for whom all other therapy has failed," McCallum
and Sarosiek also included research abstracts with the request.
...The abstract cited two articles, both written by McCallum, the head of KUMC's program.
"Coventry put no evidence before the Court which would indicate that the gastric stimulator implantation was experimental or investigational, indeed the only evidence presented was from Dr. McCallum
who stated to a reasonable degree of medical certainty that procedure is not experimental or investigational.
"Additionally, even though Dr. McCallum
is conducting additional clinical trials on the device and procedure to maximize its efficacy, this does not mean that the procedure is experimental.It only means that Dr. McCallum
is trying to make it better," Roldan said.
testified "to a reasonable degree of medical certainty" that the procedure isn't experimental and that Moses is an ideal candidate.
testified that devices are not classified according [to] the Phase I, II or III classifications within the FDA
," Roldan said.
testified to a reasonable degree of medical certainty that this procedure is the standard treatment for patients with gastroparesis similar to [the insured] who have failed all other therapies and treatments that are available."