FDA approves humanitarian device exemption for instrument set to treat rare disorder affecting fetal twins

25/04/2006 | الشركة

CULVER CITY, CA (April 25, 2006) – KARL STORZ Endoscopy-America, Inc., a world leader in diagnostic and operative minimally invasive endoscopic technology, announces that the Food and Drug Administration (FDA) has approved a Humanitarian Device Exemption (HDE) for the company’s Fetoscopy Instrument Sets used for selective laser photocoagulation (S-LPC) to treat fetuses with twin-to-twin transfusion syndrome (TTTS), a rare disorder of the placenta that affects identical twin pregnancies. In TTTS, blood can flow unevenly between the fetal twins, with one receiving too much blood while the other receives too little.

“KARL STORZ is now the only medical device manufacturer in the U.S. that will offer an FDA HDE-approved product for treating TTTS,” says Thomas Prescher, Ph.D., Director of Marketing, Gynecology/Video, KARL STORZ. “Using the Fetoscopy Instrument Set, physicians may be able to prolong the pregnancy to improve the odds of survival and reduce the likelihood of complications for one or both twins. FDA’s approval of the HDE for our product provides a vital option for surgeons encountering TTTS. It also offers hope for the parents of twins with this condition.”

The KARL STORZ Fetoscopy Instrument Sets will be marketed under the FDA’s Humanitarian Use Device (HUD) program, which encourages development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the U.S. per year. To receive approval to market an HUD, the applicant must demonstrate the safety and probable benefit of its device. Such products can only be used under the supervision of a local Institutional Review Board. The Fetoscopy Instrument Set is only the 38th product that the FDA has approved for marketing as a humanitarian use device.

"Technological and design improvements in this new generation of fetoscopic equipment will allow improved visualization and a less invasive approach to selective laser therapy for TTTS that will undoubtedly result in improved survivals and clinical outcomes in these children,” says Mark Paul Johnson MD, Director of Obstetrical Services, Center for Fetal Diagnosis & Treatment, Children's Hospital of Philadelphia, and Principal Investigator in clinical studies involving the Fetoscopy Instrument Set at that facility.

Once a diagnosis of TTTS has been made, the Fetoscopy Instrument Sets are intended to be used for S-LPC to treat the condition in fetuses whose gestational age is between 16 and 26 weeks. The instrument sets should not be used when certain conditions exist, including ruptured membranes, chorioamnionitis, placental abruption or active labor.

The set consists of a fetoscope, which is essentially an optical device used to view a fetus within the uterus, and sheaths that are used to pass other surgical instruments and/or fluid through the entry site, which is a tiny incision in the mother’s abdomen. The instruments are inserted using ultrasound guidance and, once the shared blood vessels on the placenta are identified using the fetoscope, a laser can be passed through the sheath. The laser, which was previously cleared for marketing, is used to photocoagulate the shared vessels. This helps to normalize the flow of blood between the twins. After all target vessels are identified and treated with S-LPC, the laser, fetoscope and sheath are removed.

What Is TTTS?
TTTS is a rare disorder of the placenta that sometimes occurs when women are pregnant with identical twins. During the development of identical twins, blood vessels in the fetuses' shared placenta connect their blood circulations. In most cases, the blood flows properly through these vessels. However, in TTTS, the blood begins to flow unevenly, with one fetal twin receiving too much blood (the recipient) and one receiving too little (the donor). The condition can cause heart failure in the recipient twin and life-threatening anemia in the donor twin. Most often, these babies do not survive delivery or are born with severe handicaps.