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The CyberKnife For Surgery Instead Of Radiation

Source

Introduction To Accuray

Referred to Karl by a friend, see below.

Trademark Data below

FDA Request For Approval

FDA Approval

Treatment delivery overview

About Accuray

Personal Message from Karl To Accuray
 

Karl Loren Note:  Despite the deceptive name, this is not a "knife" or "surgery" treatment, but a radiation treatment claimed to be so precise as to not damage so many adjoining tissues as are normally included in traditional cancer radiation.

Bonnie's radiation treatment was deliberately aimed at 5 cm above, 5 cm below, etc., where the main mass of the cancer was shown to be by CAT Scan.  Since the PET Scan (more discriminating than the CAT scan) can only see cancer cells of 7 mm or larger, it would be easy for live cancer cells, smaller than 7 mm, to be some small distance from the main cancer mass, and be missed unless this method of deliberately targeting some amount over and under the known mass.

Radiation is a "beam of free electrons" and I know of no method by which the "reach" of this beam can be held to just the "thickness" of a cancer.  In other words, the beam might be tightly controlled to the edges of the cancer, but would shoot through the cancer, and whatever was in front, or behind, to kill whatever good cells might be there.

I may be wrong on this, but these comments are what any informed technician would ask about -- and for which I did not find answer s on their web site.

I've checked this out, a bit, and all the information on the web is to offer a "business plan" where you can invest your money to set up a "referral center."  The technology is amazing, as implied, and suggests "surgery" without blood and without any incision into the body.  In fact this nothing more than more carefully aimed radiation, not surgery.  To say that "there is no blood" is to imply that it is, somehow, bloodless surgery. 

Presumably after you invest in the training to "run" a referral center, your "business opportunity" would be to refer patients to the ONE (??) facility where this machine is working?  I did not check that far -- all you can get on the web is information on HOW to request brochures and paper that describe how you can invest in a business plan to refer -- not to own or operate a device.  It sounds like a high technology device that may or may be real, but will certainly cost a great deal of money to get started.

July 9, 2004


 

Introduction

The CyberKnife® represents an entirely new approach to radiosurgery.

Incorporating a compact, lightweight linear accelerator mounted on a robotic arm, the CyberKnife provides the surgeon unparalleled flexibility in targeting.

Advanced image guidance technology tracks patient and target position during treatment, ensuring accuracy without the use of an invasive head frame.
 

The CyberKnife with DTS (Dynamic Tracking Software) is cleared to provide radiosurgery for lesions anywhere in the body when radiation treatment is indicated.

The CyberKnife has often been used to radiosurgically treat otherwise untreatable tumors and malformations. Moreover, this instrument treats tumors at body sites, most of which are unreachable by other stereotactic systems.


Click to launch video.
Click to download QuickTime.
Why we developed the CyberKnife ®
John R. Adler, Jr., MD
Chief Medical Officer, Accuray

 
Computer-controlled robotic arm provides access to lesions unreachable by most other stereotactic radiosurgery systems
Advanced image guidance technology tracks patient and target position during treatment
Cyberknife with DTS is now FDA cleared to provide radiosurgery for lesions anywhere in the body when radiation treatment is indicated.

 

CyberKnife®
Brochures
 
CyberKnife® Radiosurgery Patients Guide Brochure PDF
Requires Free Adobe Acrobat Reader

 



To: karl@karlloren.com
Subject: About Bonnie...resources for you two...keep hope alive....

Thanks for letting us share in Bonnie's treatments and recovery...I just got to read your newsletter after being away for a while...

I don't know if this helps: but I had a tumor in an "odd"
place and after doing internet research I found help at Stanford Hospital in Palo Alto...my own hmo doctor didn't wish to share with me this resource.
For about two years I lived with a brain tumor(turned out to be benign ..knocking on wood) on a watch and wait status and did my own research and found this resource:

http://www.accuray.com/cyberknife.htm

read about this...Perhaps it can help as you put the puzzle pieces together.
You see, I found once you're diagnosed and get the cancer size and staging, you don't always have to go the chemotherapy route: one alternative is to seek the latest computer technology in the bio field...dr's don't tell you about the clinical trials in this area. Now this machine which was used on my tumor was able to abate it's growth after 3 daily treatments (outpatient) without screws to the head or anything. The latest technology was to take a picture of the tumor site and the computer directs the arm of the robot to treat it. It has a high accuracy rate...

Another thing I learned is to ALWAYS seek a 2nd and 3rd opinion from a dr at a research hospital such as Stanford...
Anyway I highly recommend them....

And as far as alternative approaches outside of medicine , don't give up on the field of Macrobiotics...here is a link:

http://www.kushiinstitute.org/whatismacro.html

Keep an open mind: trust your instincts; get second opinions, and don't be afraid to try some alternatives...

Keep the faith,
Sandra
 


Source

Link to TARR(TARR contains current status, correspondence address and attorney of record for this mark. Use the "Back" button of the Internet Browser to return to TESS)

Typed Drawing


Word Mark

CYBERKNIFE

Goods and Services

IC 010. US 026 039 044. G & S: stereotactic radiosurgery and radiotherapy apparatus in the nature of a robotic linear accelerator used for the precision delivery of therapeutic x-rays. FIRST USE: 19970918. FIRST USE IN COMMERCE: 19970918

Mark Drawing Code

(1) TYPED DRAWING

Serial Number

74452587

Filing Date

November 1, 1993

Current Filing Basis

1A

Original Filing Basis

1B

Published for Opposition

March 14, 1995

Registration Number

2159142

Registration Date

May 19, 1998

Owner

(REGISTRANT) Accuray Incorporated CORPORATION CALIFORNIA 1310 Chesapeake Terrace Sunnyvale CALIFORNIA 94085

Assignment Recorded

ASSIGNMENT RECORDED

Attorney of Record

MARK G. LAPPIN

Type of Mark

TRADEMARK

Register

PRINCIPAL

Affidavit Text

SECT 15. SECT 8 (6-YR).

Live/Dead Indicator

LIVE


Source

Center for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

horizonal rule


 

New Search

Back To Search Results

510(k) Premarket Notification Database

Device Classification Name

cytokeratins

510(k) Number

K041315

Regulation Number

866.5550

Device Name

CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/R

Applicant

ACCURAY, INC.

1310 chesapeake terrace

sunnyvale, CA 94089

Contact

anne schlagenhaft

Product Code

LYE

Date Received

05/17/2004

Decision Date

06/10/2004

Decision

substantially equivalent (SE)

Classification Advisory Committee

Immunology

Review Advisory Committee

Radiology

Statement/Summary/Purged Status

Summary only

Type

Special

Reviewed by Third Party

No

Expedited Review

No


Source

New Search

Help | Download Files | More About 510(k)

Device

Applicant

510(k)

Decision Date

acs:180 and advia ce bayer healthcare, ll

K040425

06/14/2004

vidas d-dimer exclus biomerieux, inc.

K040882

06/10/2004

cds hematology calib clinical diagnostic

K041130

06/10/2004

hemocue hemoglobin 2 hemocue, inc.

K041234

06/10/2004

cyberknife system fo accuray, inc.

K041315

06/10/2004

randox amikacin randox laboratories,

K033884

06/09/2004

bio-rad d-10 dual pr bio-rad laboratories

K041444

06/09/2004

nichols advantage ch nichols institute di

K040813

06/08/2004

vitek 2 esbl test biomerieux, inc.

K040845

06/08/2004

clearblue easy easy unipath ltd.

K041404

06/08/2004


Source

CyberKnife

Treatment delivery overview

The CyberKnife® Stereotactic Radiosurgery System is the only radiosurgery system with

a compact 6-MV linear accelerator,

a computer-controlled robotic arm with six degrees of freedom, and

image-guidance technology that eliminates the need for a rigid stereotactic frame and enables treatment of extra-cranial sites.

This combination of technology provides an essential advantage: unmatched maneuverability in targeting.

Compared to conventional stereotactic radiosurgery systems, the CyberKnife system provides:

increased access to and coverage of any target volume

broader range of clinical applications including  

 

 -

ability to treat lesions in and around the cranium that are unreachable with other systems, for example, in the low posterior fossa and foramen magnum

 

 -

enhanced ability to avoid critical structures

 

 -

capability to treat lesions in the neck and spine

 

 -

ability to treat larger tumors

 

 -

ability to treat tumors that are inoperable

 

 -

ability to treat lesions throughout the body

delivery of highly conformal dose distributions

option of fractionating treatment

potential to target multiple tumors at different locations during a single treatment

         

Source

 

Mission

Accuray is a privately held corporation whose primary focus is to revolutionize the treatment of solid cancers throughout the body by the precise delivery of high doses of radiation using the CyberKnife®  Stereotactic Radiosurgery System. Through the development and promotion of the CyberKnife system and participation in ongoing clinical research at prominent academic hospitals, Accuray will help make stereotactic radiosurgery a viable and accessible option for patients all over the world.

Located in Sunnyvale, California, the heart of the Silicon Valley, the company designs, manufactures, and distributes the CyberKnife® Stereotactic Radiosurgery System, worldwide.

 

Address:

1310 Chesapeake Terrace
Sunnyvale, CA 94089

Phone:

408-716-4600

E-mail:

ics@accuray.com

 


Source:  Personal Message
July 9, 2003

Dear Accuray,
 
I've been reading your web and wonder about something.
 
I understand that the beam of radiation can be tightly controlled to a known mass, but it seems that the beam still has to "enter" the body, and "leave" the body.  No matter how tightly controlled the target is as to "sides" the "in front of" and "behind" areas would seem to be affected the radiation beam -- causing the normal damage caused by radiation.
 
Am I missing something? 

Karl Loren
 


Source:  Company Brochure

Device

Their web site does not allow a copy of the device!

Karl

 

This web site is a breath of fresh air in a world of pollution.

 

This web site is Copyright © 2004 by Karl Loren.  Permission is granted to download, copy, distribute and use as long as the copyright notice remains attached to such use and the intended meaning is not altered.