Why are certain patients contraindicated?
The contraindication comes from clinical studies of Cala Therapy. This was a cautious indication taken due to the use of electrical current. Since seizures occur as a result of abnormal electrical activity in the brain, it was thought prudent to not use the therapy in patients with prior history of seizures. Through our experience thus far, we have not heard of the device causing seizure.
Why are patients who are pregnant contraindicated for Cala Therapy?
Cala Therapy has not been studied on patients who are pregnant.
Why are patients with an implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator contraindicated for Cala Therapy?
Implanted electrical medical devices, such as a pacemaker, defibrillator, or DBS, are contraindicated because of the potential risk for interference with Cala Therapy.
MKG-1050 Rev P Aug 2021