ARD, CAPPS, Adhesions and Adhesion Related Disorder , Internal Scar Tissue, Hope for those who suffer from Adhesions

Thursday, April 30, 2009

Covidien has CE mark for SprayShield(TM) However

IHRT IHRT IHRT IHRT IHRT IHRT IHRT IHRT IHRT IHRT IHRT IHRT



Heinz has one for "Catsup" too!
(CE mark is on back label with ingredients.)


So what exactly does that CE Mark mean for the SprayShield (TM)??

Well, in IHRT's opinion, not much at all! When one considers that almost EVERYTHING in Europe needs a "CE mark" in order for it to be "MARKETED," one can be assured that in the case of an "adhesion barrier" being used in the human body as an adhesion retardant, well, it differs little from that same surgery being performed using "Catsup," aka "Tomatenso├če" just because it has a CE mark!
Yup, Covidien expresses in it's introduction of the SprayShield (TM) Adhesion Barrier that it has the "CE Mark"...like that is supposed to impress who, patients? Heck, even patients know that the CE mark means little for anyone seeking an adhesiolysis with the use of SprayShield(TM)! Maybe it impresses surgeons, and researchers, but ARD patients, NOT!




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Yes, folks, Catsup also has the exact CE mark as SprayShield(TM) Adhesion barrier by Covidien!


Covidien Introduces the SprayShield(TM) Adhesion Barrier System to the European Marketplace
Sprayable hydrogel technology offers surgeons a valuable tool to help reduce the incidence, severity and extent of post-surgical adhesions.

NORTH HAVEN, Conn.--(BUSINESS WIRE)--
Covidien (NYSE: COV, BSX: COV), a leading global provider of health care products, today announced that its Surgical Devices business unit has introduced the SprayShield(TM) Adhesion Barrier System throughout Europe. The SprayShield Adhesion Barrier System offers surgeons a unique synthetic, sprayable hydrogel that provides a strong barrier between tissue and organ planes that helps reduce the development of post-surgical adhesions. The SprayShield (TM) Adhesion Barrier System, which has received CE-Mark, is indicated for use in both open and laparoscopic abdominopelvic surgical procedures as an adjunct to good surgical technique.


<><> IHRT "CE Mark Education Center"<><>

EUNICE HEALTHCARE with its experience in the clinical laboratory and research markets, will introduce your products to the European laboratory market.
European countries have many approaches but there is one common factor in the area of healthcare - the need to have CE-marking on in vitro diagnostic (IVD) products. The European Union’s IVD Directive (applied in December 2003) mandates that all IVD devices used in the human, clinical setting must be registered and have a CE-symbol affixed.

More...http://eunicehealth.com/
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CE MARKING - WHATS IN IT FOR YOU
The good news - The most obvious benefit is that the CE Marking on your product will gain you access to the European Economic Area (EEA). If the European product directives apply to your products and you want to continue to export to the European market (or introduce new products), then CE Marking is mandatory and therefore crucial to your success.
There will be only one set of laws and regulations to comply with in designing and manufacturing your product for the entire European Union (EU) marketplace. The multiple and conflicting national restrictions on regulated products will be eliminated.

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UNITED STATES General Services Administration
CE MARKING -
The CE marking (an acronym for the French "Conformite Europeenne") certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe. For a list of countries that require the CE marking, see:
CE Marking Countries. A manufacturer who has gone through the conformity assessment process, may affix the CE marking to the product. With the CE marking, the product may be marketed throughout the EU. CE marking now provides product access to 27 countries with a population of nearly 500 million.Unfortunately, there is no comprehensive list of the products that require a CE marking.
More....http://www.export.gov/cemark/doc_ce_mark_main.asp
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Is CE Required For Our Product? How Can We Get CE?
"Is CE marking required for our product? Which CE requirements our product has to comply with? Which European harmonized standards apply to our products? Which certification procedures apply?"

More.....http://www.cemarking.net/alura_xl_com/c3f05073f9fbfbf63e7636b842a82dc3.php
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"Stat decisions, during clinical studies at Endogyn!"
(Endogyn is only a web site in reality, however, Kru claims to be doing surgery, so...)

Posted Saturday, January 10, 2009 @ 07:49 AM Endogyn message board.
"Since December 2008 we are using the new SprayShield™ by COVIDIEN. I should report later in this board. " http://www.endogynserver.com/cgibin/210/cutecast.plsession=E4Iun6UHDbxGuAVBH7fPMUnwv8&action=&forum=2&thread=20815&user =&query=&msgid=&page=&sort=&do=&key=&others=

IHRT's take on Daniel doing clinical studies..... "Pass the "SprayShield (TM) please.....oh, never mind, it doesn't make any difference, I'll use "Catsup (CE)," and pass the fries too, I'm hungry!"



Guess which one gets the best results in Doc. Kru's hands?












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Answer.... In IHRTS opinion, neither "Catsup(CE)" or "SprayShield(TM)," however, in Kru's opinion....

"Please see above what happens, if surgeons don't use any adhesion barriers when using "Catsup (CE)"... here you can see that even if using the best adhesion barrier available (Catsup (CE), but WITH carbon dioxide, adhesiolysis surgery is in most cases USELESS.
This happens after a long laparoscopic adhesiolysis with carbon dioxide gas:
Another conclusion: I strongly believe that the adequate covering of the wounded area with "Catsup(CE)" is only possible WITH gasless laparoscopy. I am also very sure that our results will remain the best as long as no other surgeon performs Lift-laparoscopy for adhesion surgery."
http://www.endogynserver.com/cgi-bin/210/cutecast.pl?session=4uuoUAUKLsLe81IveeSMond0Ox&forum=2&thread=1221


"I had better stay with the Catsup (CE) for my best results because the "CE Mark" makes the difference!! "

OUCH Covidien!!!! INVESTORS BEWARE
Scarring caused by surgical gel spray



Monday, 11 February 2008

Surgical treatment hurts women but is allowed to continueANDREW GORRIE/ Dominion Post ANGRY AND AMAZE Hanifa Koya has stopped using SprayGel after her patients required further surgery to remove scars. She says the product should be put on hold till surgeons and patients can be assured of its safety.
More....... http://ihrt.blogspot.com/2009_02_01_archive.html

Bravo! Way To Go Dr. Koya! Thank-you for caring! "Applause, Applause" for Dr. Koya


!!!!! EXCLUSIVE from DANIEL KRUSCHINSKI coming to IHRT !!!!!

>>>>SUNDAY MAY 1st, 2009<<<<<

IHRT SPY IN THE SKI REPORTS ON "KRUSCHINSKI" HAPPENINGS ..

STAY TUNED TO IHRT STAY TUNED TO IHRT
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COVIDIEN 2009 News Releases
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OHHH! AHHHH!

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