All concepts, explanations, trials, and studies have been
re-written in plain English and may contain errors. I am
not a doctor
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NOTE: You can make the print bigger with the font button
on your browser! (It's usually a big "A")

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Jon's Note: This is from the pamphlet actually given to
patients when they receive the Angio Seal after a cath
procedure.

Angio Seal for Cath Puncture Sites

	The Angio Seal device closes the puncture in 
the femoral artery (groin) after a cath. Usually, 
weight or a clamping device is used to stop bleeding.
This is slow and can be uncomfortable. It also requires
at least 15 minutes of compression followed by 4-8 hours
of lying flat in bed. The Angio-Seal procedure is quick
and bleeding stops more quickly.
	The device is made of 3 absorbable parts; a 
small anchor, a collagen sponge, and a suture.
	The anchor is placed into the artery through a
small delivery system and is pulled against the inside
wall of the artery to seal the puncture. The anchor and
sponge are pinched together with the suture to form a
secure seal. A small plastic tube is used to maintain 
consistent pressure on the sponge and is removed 20 
minutes later. A sterile dressing is then put over the
site.
	Another explanation follows: the anchor and 
sponge are drawn together with the suture. A small 
plastic tube and metal tension spring maintain 
consistent pressure, closing the hole and securing the
seal. The absorbable suture is then cut at skin level.
The suture, still attached to the anchor and sponge,
retracts below the skin surface and permits healing.
In 60-90 days, the anchor, sponge and suture will be
absorbed by your body.
	Tell your doctor if you have any of the 
following conditions: an allergy to absorbable sutures,
allergy to beef products or collagen products, high
blood pressure, circulation problems, previous 
vascular surgery in your legs, pregnancy, lactation or
autoimmune disease.
	This device was shown to be safe and effective
in clinical trials but some bruising or discomfort is
common during the healing process. If you have 
persistent tenderness in your groin, bleeding, swelling,
wound drainage, numbness or tingling in your leg, fever,
warmth or bruising at the puncture site, please call 
your doctor.
	You will be given a Patient Information Card to
carry with you, that will have the number listed to call.
You will be instructed to carry this card with you at all
times for the next 90 days.
	If you need another procedure within 90 days,
tell your doctor you have an Angio Seal and give him a
copy of your Patient Information Card. Re-puncture of 
the same artery in the same area is not recommended for
90 days.
	Change the dressing daily, or more freguently as
required. Keep groin site clean with soap and water 
(unless otherwise ordered by your doctor). You can be as
active as your doctor says you can.

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St. Jude Gets FDA Approval For Cath Incision Closure Device

	March 10, 2000 - St. Jude Medical has announced that
the FDA has approved the company's 6F (French) Angio-Seal
vascular closure device. The device is used to seal arterial
punctures created during cardiology procedures. St. Jude
received European approval for the device in February 1999
and launched the product there in April.
	According to St. Jude, about 70% of the 7 million
cardiac cath procedures done each year worldwide are done with
a 6F or smaller puncture in the femoral artery (groin).