Download CARDIOLOGiC@ SYSTEMS, INC.

CARDIOLOGiC@
SYSTEMS,
INC.
—
July
18, 1997
Docket Number 95S-0158
Dockets Management Branch (HFA-305)
Food and Drug Administration
12420 Parklawn Dr., Rm. 1-23
Rockville, MD 20857
>
*
>
RE: IDE Number G960214/10
CardioLogic VEST-CPR@S st ~ G
*97 i]c~ -2
!W :O;’
Public Disclosure Ad Copy 7- &dical College of Virginia (MCV)!~,
,-I
-m*
Dear Sir/Madam:
In accordance with 21 CFR $50.25, we are enclosing a copy of the se&nd public disclosure ad in
the Richmond Times-Dispatch for the Committee on the Conduct of H#)man Research approved
clinical trial at the Virginia Commonwealth University/Medical Colle~
of Virginia under IDE
#G960214.
s,
&
If there are any questions concerning this information, please contact me at 41 0/691 -5200, ext.45.
.-
Q*AA
Timothy R. Iacek
Director of Regulatory Affairs
and Quality Assurance
Oticial Correspondent
Attachments:
CARDlOLOGIC
1.
Public disclosure ad copy from Richmond Times-Dispatch
SYSTEMS, [NC., 7455-T NEW RIDGE ROAD, HANOVER,
MD 21076-3143 U.S.A.
●
TEL 410.691.5200
●
FAX 410.691.5212
1S0-9001 CERTIFIEO
+
CARDIOLOGIC
SYSTEMS,
INC.
IDE Number G960214
Supplement
July
Number 10
18, 1997
VOLUME 1
SPONSORED BY:
CARDIOLOG~CSYSTEM? INC.
7455-T
NEW RIDGE ROAD
HANOVER, MARYLAND, USA 21076-3143
.,
.,,,.7
“.
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,
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. ....... ... .... . .. .
especially knotty public he~th prob- (
lem. About 250,000 infants are born
premature and dangerously small in
the United States each year prematurity is by far the leading cause of
newborn deaths.
Doctors have long noticed that
women with bad teeth seem more
Iike[y to give birth prematurely. Offenbacher studied 124 women and
found those with gum disease were
about eight times more likely than
usual to deliver dangerously small
premature babies.
,..
[oad of bacteria crctg, low-grade infec-
lts damage slowly
lain evidence so far
ies that follow large
?Ie to see whether
)ad gums fare diflerdon’t. The
,e Tlint t.
people with
ase have a higher
>f heart attacks.
~st impressive is the
Aging Study in Bosfollowed 1,231 men
.—
FERS FREE LECTURE
ire Not Enough”
: of grief,
pain,
apist
can help
ative
process
Central
dying
or any
heal
emotional
of art. Please
Virginia,
the--~y
,es L
loss,
people
tells
join
or
The current investigation
is designed to compare results with
this device vs. conventional
CPR in terms of the number of lives
saved and any possible adverse effects such as injury to the chest
or other structures.
Results of this study will be used by the Food
& Drug Administration
to determine whether the device will be
approved for sale in the United States.
us as Richard
us how to understand
is a very important
intervention
for
e’s journey.
z, M. Div., M. A,, A.T.R.
, July 26,1997
-lO:OOam
}ffice Building II, East Entrance
Public comments on the proposed investigation
should be directed in writing to both:
[ding II is located at 7650 E. Pal-h.{m Road.
arham Rd. Drive into Lhe first pat-king 10[ hy
1. Enrer through [he eas~ enlrance.
r reservation
by calling
747-KNOW(5669)
F#!sou77’f@
hea/thsouthicom
I
——
Virginia Commonwealth
University/Medical
College of Virginia
anticipates
that it will be participating
in an investigational
study
to eva[ua.te a new VEST-CPR
resuscitation
device. The study is
being conducted
under a recent ruling by the FDA which allows
strict circumstances,
patients
in life threatening
that undei
situations (and for whom there is no one available to give their
consent)
may be given experiments!
treatment,
if there is no
acceptable
alternative
with a good chance of success. The new
technology consists of a vest device that can be wrapped around
the chest. lf a person’s heart stops beating, rhythmic inflation and
deflation of the vest with air can maintain circulation until the
heart can be restarted. Thus, the device is designed to replace the
chest compressions
of conventional cardiopulmonary
resuscitation
(CPR).
In the event that a person’s heart stops beating suddenly and
unexpectedly
while in the hospital,
all appropriate
means
(including standard medications
and techniques) will be used to
return the normal heart beat. During the study, some persons will
have
chest
compressions
performed
by the vest device.
emotional
pain
VIRGINIA COMMONWEALTH
UNIVERSITY/MEDICAL
COLLEGE OF VIRGINIA
VEST-CPR STUDY
—-——
_—=
-
.,,,,
are welcomed
and
Joseph P. Ornate, MD
Dept. of Emergency
Medicine
Virginia Commonwealth
Uniiversity/Medical
BOX 980525
Richmond,
VA 23298-0525
College
of Virginia
Robert L. Campbell, DDS
Chairman, Committee
on Human Research
Virginia Commonwealth
University/Medical
BOX 980566
Richmond,
VA 23298-0525
College
of Virginia
ATTACHMENT
1
Institute
for Research and Technology
200 Hawthorne
Lane
Post Office Box 33549
Charlotte, NC 28233-3549
(704) 384-5369 FAX (704) 384-5638
http: //wwvJ. presbyterian.org
—
May 19, 1997
PLAN OF PUBLIC DISCLOSURE
PRESBYTERIAN HOSPITAL
INSTITUTIONAL REVIEW BOARD
CHARLOTTE, NC.
The following activities VW be initiated in order to noti@ the public that a clinical trial will
be taking place at Presbyterian Hospital regarding VEST-CPR and that informed consent
has been waived for this clinical trial
A public forum will be held on May 13, 1997 at Presbyterian Hospital for the purpose
of disclosing to the public the VEST-CPR protocol, including the background,
exclusiotiinclusion criteri~ risks, potential benefits, implementation, alternatives,
cost.kompensatio~ confidentiality, and data to be gathered. A discussion of the FDA
guidelines for research without informed consent will also be provided. There will be
a question/answer session after the presentations. The public’s attendance,
participation and comments will be documented. See attached agenda.
●
—
. Two notices will be placed in the Charlotte Observer newspaper on a weekend day
and a weekday immediately prmeding the event. The circulation is greater than
300,000 on a weekend and greater than 200,000 on a weekday in the
Charlotte/Mecklenburg area.
. An article describing the study in more depth will be written after an interview with
the Foundation coordinating the study. It VW be placed in the newspaper
immediately prior to the community forurn.
. Notices will be fa..ed to appropriate physician offices, posted in the hospital and
medical tower elevators, and sent to the health services distribution list to infbrm the
public of the cmnnumity forurn. The staff in these places will be asked to post the
notices in areas where the general pubtic can see them.
. The public’s comments will be rmiewed prior to application for final approval of the
project.
. Large signs will be posted in a prominent place on each hospital unit involved to
inform patientsbmilies of the study and the procedure to decline participation.
VEST-CPR informative pamphlets will be placed in each patient room on the
identified units.
.
Further notifications with the public, in an attempt to update them on the progress of
The Whole Approach To Health.
Presbyterian Hospital, Presbyterian
Hospital, Presbyterian Healthcare
Hospital Matthews, Presoytefian Hereby Children’s Hospilal, Presbyterian OrYcoaedc
Hoso!al Presbyterian Spec~aity
Associates, PresbyTer:a~. Health Net,vork, ‘resbytenan
Wesley Ca,e Cfm:e mm ~,e~oy:~rlan Hosg,:al ~Ou~Cai’Ofl
—
Page 2
the study, will include notices in the paper~bove
media as deemed necessary.
Robert F
Chai
Y
S’titUtiO~
Review
.
Board
and
potially
other
forms of
h
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THE CH.WiLOTTE OBSERVER
*
—
HospitalwantsinputonCPRvest
FORUM
Continued jimnt page IE
I
—
matic system that sends air into the
vest to compress the whole chest,
not just the spot where the palms
press in manual CPR The vest is
already used in Europe.
During a demonstration
Iast
week nurses and respirator? therapists wrapped the vest around a
mannequin named Fred and attached a plastic hose from the vest
to a pneumatic unit beside the bed.
When they pressed a button, air
pushed through the tube with a
loud puffing .sou@ infladng the
vest and compressing Fred’s torso.
Quickly, it deflated and inflated
again, mimicking the compressions of manual CPR
But with manual CP~ Whisnant
said “there is a lot of inconsistency
in the way people do it”
If the Presbyterian study is approval patients who quaii& will
receive either manual CPR or the
CPR vest on a random basis.
When possible hospital employees will @to contact family members to get consent for the patient
to be in the study. OtherwkR
patients who survive will he asked
later if researchers can use their
experience in the study. For patients who don’t sumive, families
will be informed that their relatives
were included.
“By coming to this hospital, they
will have given consent, urks
they tell a nurse on the floor, ‘No, I
don’t want tl@’” Whim@ said.
“People might get @3rmed at that.
That’s why we want comments.”
Presbyterian first tried the experhnent 272years ago 13yasking
patients to sign consent forms in
case they might have cadiac arrest. In six months, only one consenting patient had a cardiac arrest
while in the hospital. CardioLogic
stopped the study, realizing it
would take too long to get enough
patients to prove the vesfs effectiveness.
Studies have been done before
without the consent of patients
who weren’t able to give it and for
whom relatives weren’t available.
But the new federal rules, which
took effect in November, give clear
guidelines on how to do it ethically.
Dr. Jeff Runge of Charlorte was
one of the emergency medki.ne
specialists who led the effort to get
the regulations passed.
At Carolinas Medical Center, he
a recently approved
study that also involves an emergen~ treatment. In that project,
critically injured patients who
come to the emergency room will
receive an experimental product,
hemoglobin, in addition to blood
transfusions.
To meet the federal require
ments on public notification, Carolinas Medical Center advertised for
comments fmm the community in
March. It received about 20 letters
and phone @
dl but two were
supportive.
is heading
IFYOU’RE
GOING
The free forum on the CPR
vestwiil be at 7 p.m. Tuesdayin
the Presbyterian Hospitalmultipurpose room, 200 Hawthorne
lane. To register or leave commenm call 483-2900 anytime.
ATTACHMENT
4
_—_
Forum
Explores
New CPR
Tech nology
..
b$’&gy&w&
Mid Carolina
>%,
Cardiology
will present
forum
regarding
the use of a new technology
patients
experiencing
arrest.
The vest CPR,
studied
at Presbyterian
for
cardiac
being
Hospital,
potentially
better
R. A vest, similar
J&;g”w$-
to a blood pressure
the patient’s
research
suwival
chest to do compressions.
hopes
to demonstrate
for patients.
ruling on waiver
community
cuff, is placed around
This
increased
Under the new federal
of informed
notification
consent,
is required
prior to
initiating this research.
Call483-2900
with comments
and to register.
May
Presb@ti;
Specialty Hospital
Presi@ertanOrthouaedic Hosnital
—
Presbyterian Heailhcare .Associates
PreshytwkrrrHe
aithNetwork
Presbyterian Wesiey Care Cenier
Prestryteriarr Hospitai Foundation
~ ~,
13, 1997
7:00-8:30
pm
Presbyterian
Multipurpose
Hospitai
Room
200
Lane
Hawthorne
:(, ;,~,
:c
:iiti~
:.;znge ;?
needed on
!:nev.~io~-mezt
in
:~~$~
%e
~,n~~:
.:cr.ti~e~t
~ti;ain
k onlj
~ercent, but it’s 12.;3perc~nt~
.Tydnce~. .9.1 percent ~n IZ3@,1~.;
ii
;e~cent in Germany and almos~
22 ?erc?nt in Spain.
h
achieving consensus h-i Edmgesn counties
on wnat to da
aixut it is allbut impossfole. in part
is
because the pditicd
qxctr-um
inLx5 more fmgmenred than in
13tirain. Fu@er, in much of the
represencontinent,
yo~rtionai
tation imposes a need for coalition
gove~men~.
Thatcher disliked consensus,
and ‘@use Gfthe British electorai
system. she won healthy majorities
in Pwiiarnent even though her
Conservatives never won a majority of the popular vote.
T’nus she was able to break . the
....
that British labor
stranglehold
unions
had over the economy
when siie anived in power, and she
Legislated tlexibdity in British hir-
A Spe
inF%:
ing and ,tig
practices. She was
also ahie to cut British income
taxes to a ;op rateof 40 percent —
about what .4rne5cans in the upper
tax ~mckets gay on some of their
income huz & less than whar the
richest pay h France (54 percent)
Orin Germany (53 perwnt).
Two d~des
later, Blair has
accepted most of these T&m%etite
prescriptions as Hsentiai for 13fitain to compete a%ctively
new @obal .~onomy.
in the
Loans
blood pressure cuff, is placed around the
patient’s chest to da compr~ions.
l%is
research napes to demonstrate increased
SWviVal for Patienk. Under the new federal
ruling on wavier at informed consent,
ccmmunl~ nolificatian is reauirea gricr to
initiating this research.
Ca/1 483-2900
withccmments znd tc ,.egisky
I
ATTACHMENT
11’
II
5
AGENDA
VE5T-CPR@ PUBLIC FORUM
MAY 13,1997
7:00 pm
Welcome/Introductions
Dr. Kremers,
7:05 pm
Mid
FDA Guidelines
Presbyterian
Review/Demo
Mid
Review/Demo
Elaine
8:00 pm
Carolina
Standard
Presbyterian
7:50 pm
Hospital
Protocol Review
Risks & Benefits
Dr. Kremers,
7:40 pm
Cardiology
and IRB
Dr. Farnham,
7:20 pm
Carolina
Cardiology
CPR
Hospital
VEST-CPl@’
Hartnett,
CardioLogic
Systems,
Inc.
Questions
ul
I
.
QUESTIONS
PLEA5E
AN5WERA
FEW QUE5TION5
1. Age?
<40
2.
Sex?
Male
3.
Race?
BY CIRCLING
<50
50-65
THE
APPROPRIATE
ANSWER.
>65
Female
Caucasian
African
Asian
American
Hispanic
Other:
4.
Occupation?
5.
Do you work in healthcare?
yes
no
6.
Are you certified in CPR?
yes
no
7.
Have you ever given CPR?
yes
no
8. Do you know anyone
who has received
9. Have you had any experiences
CPR?
with Presbyterian
If yes, in what way?
10. Do you approve
11. Comments:
of this study?
yes
no
yes
no
Hospitai?
yes
no
—
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QUESTIONS AT COMMUNITY FORUM
1) I thought there was no crossover, but yousaid manual would be used first, then vest ?
i
d -.
z)
Do
YOU see
this eventually reaching out into the field (ie.medics)?
3) Is the pressure automatically
adjusted or can you regulate it?
4) What other kinds of human errors are possile?
.,
,.
5) Is the vest for multiple use?
.
6) What kind of power does this use, 11O?
‘. .
7) Would the pressure be the same on a child?
8) Can you install the vest too snug or too loose?
9) If you have a cardiac arrest due to a blood clot in the artery, could the vest push the clot
-.
away?
10) Has the vest been used on humans?
(
.-
11) It seems like everyone’s fascinated with the technology all over the country, what kind of
experience is there with the waiver? (It seems like from the public, the technology questions are
the ones that come up.)
12) From the insight of having undergone CPR, why would people object to its use?
13) I can’t tell someone that I w
this when I’m admitted?
to consent if I come to this hospital?
I can’t say yes I want
14) Can’t you just make it part of the admission question?
15) Why couldn’t you go ahead and use it in the ER?
16) This study is 2 years or 15 years’?
17) If successful, how quickly would it go to the next phase and try pre-hospital?
18) WiIl there be a randomized study pre-hospital?
19) Given that it will take X amount of time to perform this study, what is the ratio that will
receive the vest outside of all the variables,mentioned? (ie. #admitted, fit criteria looks like
obvious place to do this is in the ER, couldn’t this study take a long time?
.—=
(--”
20) Do you get the consensus from the entire medical staff for their patients?
21) Will you track the patients beyond the 6 month length of time? Will you not see a major
change afier 6 months ”(neurologically)?
. ..-.
.
.
..
.
———
——
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