FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Karl Storz Rigid TTTS Fetoscopy Instrument Set with 0 and 12 degree scope, Karl Storz Rigid TTTS Fetoscopy Instrument Set with 30 degree scope, and Karl Storz Semi-Rigid Fetoscopy Instrument Set
Manufacturer: Karl Storz Endoscopy America, Inc.
Address: 600 Corporate Pointe, Culver City, CA 90230
Approval Date: March 31, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/h040005a.pdf
What is it? The Karl Storz Fetoscopy Instrument Sets are surgical tools used in the treatment of twin-to-twin transfusion syndrome (TTTS). TTTS is a rare condition in which there is an imbalance in the amniotic fluid of some identical twins. This imbalance is caused by an uneven flow of blood between the twins through shared blood vessels that are present when the twins share one placenta.
The Karl Storz Fetoscopy Instrument Sets consist of a fetoscope (telescopic camera used to view a fetus) and sheaths which are used to pass other surgical instruments and/or fluid through the entry site. After identifying the shared blood vessels on the placenta with the fetoscope, a laser can be passed through a sheath. The laser, which is already cleared for marketing, is used to photocoagulate (destroy with heat) the shared vessels which should help to normalize the flow of blood between the twins.
How does it work? After a tiny cut in the mother’s abdomen is made, the fetoscope and sheath are inserted through the mother’s abdomen and uterus under ultrasound guidance. Through the fetoscope the surgeon is able to view the placenta and determine which blood vessels are being shared by the twins and which ones are not. The Fetoscopy Instrument Set provides a pathway for a laser that can be used to destroy these shared or shared vessels after they have been identified. After all of the target vessels are identified and treated, the laser, fetoscope and sheath are removed.
When is it used? After a diagnosis of TTTS is made, the Karl Storz Fetoscopy Instrument Sets can be used for the treatment of TTTS for fetuses whose gestational age is between 16 and 26 weeks (second trimester).
What will it accomplish? The use of the Karl Storz Fetoscopy Instrument Sets may prolong the pregnancy and improve the odds of survival and lack of complications of one or both twins.
When should it not be used? The Karl Storz Fetoscopy Instrument Sets should not be used when the following conditions exist:
- ruptured membranes
- chorioamnionitis (infection of the membranes or placenta)
- placental abruption (placenta separates from uterus (womb)) or active labor
SSPB and Labeling: The SSPB will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=h040005.