ML20211K457
| ML20211K457 | |
| Person / Time | |
|---|---|
| Site: | 07001402 |
| Issue date: | 08/23/1973 |
| From: | Jonathan Brown US ATOMIC ENERGY COMMISSION (AEC) |
| To: | George M, Knowlton S ABINGTON MEMORIAL HOSP., ABINGTON, PA |
| Shared Package | |
| ML20211K358 | List: |
| References | |
| NUDOCS 8606270403 | |
| Download: ML20211K457 (2) | |
Text
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ATOMIC ENERGY COMMISSION
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Abington 1%torial Hospital ATTN: Mr. Morris F. George, and Dr. Stephen B. Knowlton, Jr.
1245 Highland Avenue Abington', Pennsylvania 19001 Gentlemen:
Thin is in reference to your application dated 7~20-73
, to participate in the investigational program utilizing Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse Generators.
The implantation of these devices in patients is being licensed only on a limited investigational basis until it can be established that:
(1) nuclear pacemakers are safe and reliable, (2) wide scale use will not subject the public to undue risk and (3) the benefits to be derived by patients using nuclear powered pacemakers will outweigh the risk, however small, to the public which might occur through an accident involving a pacemaker bearer or loss of the pacemaker to the environment.
During the investigational phase of nuclear pacemaker use, licenses are being issued only to medical institutions that can assure continuity of follow-up of patients with implanted pacemakers, and not to individual physicians.
The physician (s) designated in an application as the responsible investigator (s) should have substantial experience with pacemakers in the specialties of cardiology and thoracic surgery, and the applicant medical institution will generally be expected to have an established program for the implantation and follow-up of cardiac pacemakers.
Your application incorporates the medical procedures as outlined in the Medtronics Protocol of March 21, 1973. You will notice that Item I.D.4 of this protocol provided that " myocardial leads (Medtronic Model 5814), will be used with one of the several surgical approaches available to either the left or right ventricular surface of the heart. The pulse generator will be placed into the subcutaneous tissues of the abdomen or the chest wall.
If this pulse generator is replacing another, the existing lead cyatem may be used. If the surgical procedures for placing myocardial leads are contra-indicated for the patient because of the risks of a thoracotomy, then other surgical techniques or endocardial transvenous leads may be used.
In any event, the leads used must have a connector that is compatible with the pulse generator or compatibic with a standard adaptor used with the pulse generator; splicing of leads will not be allowed."
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a"- The protocol designates myocardial leads as the primary choice and endocardial as secondary for those cases when thoracotomy is contraindicated.
With reference to the above, your application should be supported with the additional information checked below:
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1.
The application was not signed by the hospital's or institution's adminis trator. A statement in support of the application should be sub-mitted by an official of the hospital or institution who has authority to sign on behalf of the applicant.
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2.
Previous experience in the implantation and follow-up of implantable pacemakers by the physician (s),
include total numoer of implants the physician has done, the total number he has done at applicant's facili-ties, and a breakdown of how many of these implants using myocardial leads.
(other physicians listed in your letter dated July 20 1973 A statement clarifying the physician (s) position with 'the ap)plicant.
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3.
For
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- 4. Xkx)decua600000R P ysicians and surgeons participating in the study.
h Provide same information as required for the physician responsible for the study.
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5.
A detailed description of the modifications the study team desires to make in the Medtronic Protocol.
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6.
The number of Medtronic Laurens-Alcatel Model 9000 pacemakers requested to be implanted annually during the study.
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7.
A complete description of the physical facilities and equipment of the applicant institution. Describe cardiac care unit, operating facilities, and each piece of equipment needed and available to carry out the study.
List the equipment available to perform the test procedures on the pacemakers as indicated in the Technical Manual.
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8.
A more complete description of the applicant institution's present pace-maker implantation and follow-up program.
Include size; duration and types of implantations.
We will continue review of your application promptly upon receipt of the requested information. Your re; ly should reference Docket No.
- 10-1402 Sincerely, J. M. Brown, Jr.
Materials Branch Directorate of Licensing