Safety has been our Priority since the inception of the PIE* System/Procedure.

The following are extracts from a VA study documenting the safety of the PIE* Procedure for one time or ongoing use every other day.

Electrolytes Disturbed?

Results - Safety.
Blood electrolytes are not affected in any manner by long-term use of the PIEE Procedure (Table 1)


TABLE1: INDIVIDUAL SUBJECT'S ELECTROLYTES

Days of Study

Sodium

Chloride

Potassium

Calcium

Phosphorus

Incidence of Out of Range

 

 

 

Patient #1

 

 

 

Baseline

142

102

4.3

9.4

3.9

NONE

30 Day

139

105

4.8

9.6

3.6

NONE

60 Day

140

103

4.6

8.8

3.8

NONE

90 Day

140

103

4.6

8.8

3.8

NONE

 

 

 

Patient #2

 

 

 

Baseline

141

106

4

9.7

3.9

NONE

30 Day

139

108

3.4

8.7

3.6

NONE

60 Day

143

109

4.1

9.2

3.8

NONE

90 Day

141

108

4.2

9.5

3.6

NONE

 

 

 

Patient #3

 

 

 

Baseline

141

104

4.5

9.1

3.5

NONE

30 Day

141

107

4.1

9.1

3.5

NONE

60 Day

141

107

4

9

2.7

NONE

90 Day

140

103

4.5

9.2

4.8

NONE

 

 

 

Patient #4

 

 

 

Baseline

143

111

4.8

9.2

3.6

NONE

30 Day

140

103

3.8

8.4

3.3

NONE

60 Day

139

105

4.1

9

3.2

NONE

90 Day

 

 

 

 

 

NONE

 

 

 

Patient #5

 

 

 

Baseline

137

96

3.5

8.8

4.4

NONE

30 Day

132

91

3.5

9

3.8

NONE

60 Day

136

99

3.6

8.6

3.6

NONE

90 Day

139

105

4.1

9

3.2

NONE

 

 

 

Patient #6

 

 

 

Baseline

142

106

4.8

10.9

3.4

NONE

30 Day

142

106

4.8

10.9

3.4

NONE

60 Day

142

106

4.4

10.4

3

NONE

90 Day

141

107

4.2

10.4

3

NONE

 

 

 

Patient #7

 

 

 

Baseline

140

105

4.2

9

4.2

NONE

30 Day

138

102

4.7

8.9

3.5

NONE

60 Day

137

101

3.8

8.9

3.2

NONE

90 Day

136

99

3.8

8.5

3.6

NONE



Concerned about whether or not the PIE* Procedure will cause Autonomic Dysreflexia?
The Chart below was taken from this same study.


Autonomic Dysreflexia?
The PIEE Procedure shows a positive improvement regarding vital signs (reflective of autonomic dysreflexia with respect to prior bowel programs).
Figure 1

The PIEE Procedure shows a positive improvement regarding vital signs (reflective of autonomic dysreflexia with respect to prior bowel programs).



Very Interesting Information! We owe the Veterans Administration a BIG THANK YOU for all the fine work they have done using the PIE* System/Procedure/Therapy proving that the PIE* is a thoroughly safe medical device.
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