The VST was required to go through the the FDA 510(k) Registration and Approval Process. It had to address some requirements surrounding treatment of potential patients that had certain “existing conditions”. It passed every requirement on first attempt, which does not happen very often with anything subjected to the FDA’s approval process.
If a patient had these types of conditions, most of the time we could not treat them with the VST without involvement directly in the presence of their specialty physician. The Contra-indications are as follows:
- Do not use with implanted pacemaker (demand type)
- Unless specifically exempted by a physician, the VST MyoDynamic Device is not recommended in the following instances:
- Denervated Muscle
- Severe Osteoporosis
- Limited range of motion in joints where treatment is to occur
- Abnormal bone formation in treatment areas
- Severe Muscle spasticity
- Autonomic dysreflexia
- History of joint disarticulation of treatment limb
- Infection in the areas of treatment
- Heart disease
- High fever
- High blood pressure,
- High heart rate and
- Unless specifically exempted by a physician, the VST Myo Dynamic Device should not be used on cancer patients (with active cancer cells). Peripheral neuropathy can actually be instigated or perpetuated by certain aspects of chemotherapy.
- Do not use the VST if you have a medical condition which impedes return blood flow. Venous systems that are too weak or are impeded in some way from returning blood the arterial system has supplied can result in painful swelling if the VST is applied. The reason for this is because the VST can increase the supply of blood to an affected area by up to 10 times over what the body is normally able to do for affected areas. Since a single 40 minute treatment can result in this sort of blood flow improvement, any impediment to blood flow return of the nature described here can be problematic. If that happens, we just have to patient and stop treating for 3 to 5 days, then resume therapy with a reduced number of treatment sessions. Sessions timing might also need to be modified to occur only during the day. This allows the venous system to move the fluid away overnight to be processed by the liver more effectively.
THIS SEEMS LIKE AN ODD PAGE TO SAY THIS:
It’s a great tribute to Steven Petrofsky, our brilliant Electrical Engineer, that the approval happened so smoothly. Steve’s background includes working with NASA on the Space Shuttle’s Robotic Arm, so he is no stranger to critical safety requirements and results-oriented outcomes.