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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 “. u“,, , ,,’,, . ....... ... .... . .. . 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 ,, I $%% “WWUJm a!lqnd qaas puB fi!u -numma aq} o~ UMouq sa!pny J!aq] aqwu o~ waqa.u?asaJ aJ!nbaJ OSIU sapu aq] ~n~ “smuafhawa [eo!paw u! s]uauq8aJ] +h.q]sa] uaqM ~uas -uim pauuojtq ah~tmt0; iwaq3Jeas -aJ MOIIFI sapu luJapaj MaN ‘Uoyil -spread aA!~ I,um Aaqt q]uap Jeau 0s OJU Oqt%tslua!~ud Uo JSaA aq] 2h.q&} ueaw plnoM ]Sal aqt ]na apaddojs aAeq s~eaq &OqM s]u”iq~ud aA~AaJ. 0) ~d~ pmueiu ueq] Ja~aq WJOM JsaA~d~ MaU B j! aas 0] aq![ plnOM 18J!dsoH [email protected] ]8 SJaq3J8?Sa~ &3J?Jfi @jS H301W3 L IULUC+”ULAUUUIUJU NWW)I @ 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 — < _. .— b----- LJ— 75 ~ w .— 76 Clm -c v % w w c? tY Q m L) ccl AN m y > ~ o mm Zm o In VCO o =rCN vl- __—__ Lu u < f“ C%N ) 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? 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