Всем кто использует крытые стенты - "Народ за Гарри Фли

и ангиология

Модератор: Pyankov Vasily

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Мария Ильина
Сообщения: 150
Зарегистрирован: Вс май 06, 2007 1:29 pm
Откуда: Royal Hospital for Sick Children, Yorkhill, Glasgow, UK

Всем кто использует крытые стенты - "Народ за Гарри Фли

Сообщение Мария Ильина »

Dear Pediatric cardiologist - Interventionalist ,


In his ongoing problems with the US FDA, Allen Tower, founder and CEO of NUMED, is threatened with a huge fine and imprisonment by the US Government. He is being charged in a case related to supply of compassionate use of covered CP stents and BIB balloons; apparently the way the company delivered the stent was illegal by US law. Most of the centres had complete documentation of these requests but a few did not. It is rather a clinician's problem of not completing documentation and using devices which parents were not informed about their compassionate use. Allen clearly supplied them in good faith, but in FDA's view the manufacturer is culpable. This will have implications in US, because if this judgement goes ahead, the parents of children in whom these stents were used will also file law suits. Furthermore, the US Federal Attorney is stating that transporting the devices across the New York State boarder (in order to ship to Canada or Europe or anywhere else in the world ) was violating "interstate commerce", so their use in Canada and Europe in spite of CE mark was illegal (guess what this makes you .....) . This court case seriously threatens further work by Allen Tower, if not the existence of the NUMED company, and any further development of devices if an American company is involved ! This obviously will significantly influence the treatment options you can offer to your patients worldwide !



We would be grateful for your urgent help. Please read and sign the petition at http://www.thepetitionsite.com/takeaction/250006502 . The petition is automatically sent to Jim Bessette, Allen's lawyer.


Can you also send this email urgently to all your paediatric cardiology contacts around the world.



This is an occasion when all of you can show that we all care for our patients and therefore need companies such as NuMED to continue.



Many thanks and best wishes,



Shak Qureshi, Mike Tynan and Marc Gewillig
Максим Осипов
Сообщения: 1028
Зарегистрирован: Пт мар 23, 2007 6:42 pm
Откуда: Таруса, Москва

Сообщение Максим Осипов »

Подписал, больше из русской привычки верить людям, чем из чего бы то ни было еще...
MGilarov
Сообщения: 441
Зарегистрирован: Вс апр 01, 2007 8:10 pm
Откуда: Москва, ММА им. И.М. Сеченова

Сообщение MGilarov »

Я тоже... У нас принято "милость к падшим призывать"
С уважением,
Гиляров Михаил Юрьевич
Ren_Yumi
Сообщения: 1338
Зарегистрирован: Сб мар 24, 2007 9:41 pm

Сообщение Ren_Yumi »

Кажется, человек хороший. Подписала. Правда, не припомню, чтобы кому-нибудь помогали петиции.
Мария Ильина
Сообщения: 150
Зарегистрирован: Вс май 06, 2007 1:29 pm
Откуда: Royal Hospital for Sick Children, Yorkhill, Glasgow, UK

Сообщение Мария Ильина »

Thank you kindly, everyone! Just like cardiac drugs, many interventional gadgets (in this case, covered stents and "balloon in balloon" catheters) are developed for use in adults. These often are not legally approved for use in paediatrics because there simply isn't enough research being done on little people (numbers too small, often unethical to randomize). We won't be able to perform many life and surgery-saving procedures if the FDA takes a harsh stance.

I assure you, you are in good company. The above letter is mailed to all members of the AEPC (Association of European Paediatric Cardiologists) and the petition is signed by some of the world's most prominent congenital interventionalists.

Just as a curious fact, low profile low pressure Tyshak balloon catheters are used in most "congenital" cath labs all over the world; they were invented by Mike Tynan and Shak Qureshi who wrote the letter.
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