This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Femoral Introducer Sheath and Hemostasis Device (FISH™)
PMA Applicant: Morris Innovative Research, Inc.
Address: 907 W. Second St., Bloomington, IN 47403
Approval Date: August 20, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050043a.pdf
What is it? The Femoral Introducer Sheath and Hemostasis Device (FISH™) is used to stop bleeding at a puncture site following 5, 6, or 8 French diagnostic, cardiac catheterization procedures. Instead of using manual compression (using the hands) or mechanical compression (using a device like a clamp), the femoral artery may be closed with material called an extracellular matrix (ECM) that is made up of small intestinal submucosa (SIS) found in pigs. The FISH™ closure patch is supplied in a sterile, ready to use kit with access needle, guide wire and pre-dilator.
During a cardiac catheterization procedure (http://www.nlm.nih.gov/medlineplus/ency/imagepages/1080.htm) :
- A needle is used to make a small tunnel through the skin and tissue and into the femoral artery.
- A thin, flexible, hollow tube (catheter) is threaded through the blood vessel until it reaches the heart.
- The catheter is used to carry specialized tools and medicines for the diagnosis and treatment of heart disease.
- The catheter is removed and the FISH™ closure patch is used to seal the hole in the femoral artery.
How does it work?
- Following the cardiac catheterization procedure, t he FISH™ Device is placed into the vessel over the guide wire.
- After the catheterization procedure is complete, the patch is then compressed using a compression suture.
- The FISH sheath is then removed using downward pressure at the puncture site. Manual compression is applied to the vascular access site for 1 to 2 minutes prior to releasing the pressure.
When is it used? The Femoral Introducer Sheath and Hemostasis Device (FISH™ Device) is intended for hemostatic closure of femoral artery access sites. The system is indicated for use in reducing time to hemostasis and time to ambulation in patients who have undergone diagnostic procedures using 5, 6, or 8 French procedural sheaths. Patients would receive this device after femoral artery angiographic procedures, when the femoral artery must be closed to prevent bleeding. The device is used following cardiac catheterization.
What will it accomplish? The FISH™ device is an alternative to applying manual pressure (compression) or mechanical pressure (clamp) to the puncture site to stop bleeding. The FISH™ device uses SIS to seal the hole in the femoral artery and stop bleeding. The FISH™ device allows patients to get out of bed and walk sooner than is possible with standard compression methods.
When should it not be used? There are no known contraindications for the FISH™ arterial sheath and closure device.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050043