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FY 2000 ODE Annual Report - Part 1 – Advances in Patient Care

Fetal Oxygen Monitor
Middle Ear Surgical Implant
Robot-Assisted Surgery
Digital Mammography
Mapping The Heart And Treating Arrhythmia
Laser-Based Eye Surgery 
Treating Gastroesophageal Reflux Disease
FDA Consumer Web Sites
Device Databases
Consumer Information


Last year the Office of Device Evaluation (ODE) approved and cleared thousands of devices used to diagnose and treat a wide variety of medical conditions. For a complete listing of newly approved devices, please see Part 2 – INDUSTRY INFORMATION. A new Premarket Approval Application (PMA) approval website describing recently approved devices with patient information is now available at the Recently Approved Devices web page. Below we highlight several medical devices approved during this past fiscal year that we believe will have a major impact on patient care.

FETAL OXYGEN MONITOR -- The OxiFirst™ Fetal Oxygen Saturation Monitoring System, Mallinckrodt, Nellcor Perinatal Business, is a new type of fetal monitor that measures oxygen saturation in the baby’s blood as a sign of fetal health during labor and delivery. The OxiFirst™ sensor is inserted into the mother’s uterus and placed against the temple or cheek of the fetus. The monitor displays fetal oxygen saturation as percent of oxygen in the fetus’s blood. Oxifirst™ is used along with conventional electronic fetal monitoring when the fetal heart rate is "non-reassuring," that is, when the rate indicates that the baby may be in distress due to lack of adequate oxygen. It is intended for use only on single (not multiple) fetuses of at least 36 weeks gestation, where the "mother’s water" has broken and the fetal head is in the normal, head down position for delivery.

MIDDLE EAR SURGICAL IMPLANT -- The Vibrant Soundbridge, Symphonix Devices, Inc., is a surgically implanted hearing device intended to help adults with moderate to severe nerve hearing loss. The device is implanted behind the ear in the temporal (skull) bone. It converts sound to mechanical energy that is transferred to the middle ear. This energy vibrates delicate structures in the middle ear very much the way normal sound does. The brain interprets the vibrations as sound. During implant surgery, the surgeon implants a receiver behind the ear. A wire leads from the receiver to a small electromagnet attached to one of the middle ear bones. As an alternative to traditional hearing aids, adults with a moderate to severe sensorineural hearing loss may choose this device. Adults who choose this device should have already tried using appropriately fitting external hearing aids.

ROBOT-ASSISTED SURGERY -- The Intuitive Surgical da Vinci™ Surgical System, Intuitive Surgical Inc., is a robotic device that enables a surgeon to perform certain types of surgery while seated at a console with a computer and video monitor. The surgeon uses handgrips and foot pedals attached to the computer console to control three robotic arms that perform the surgery using a variety of surgical tools. The robotic arms, which have a "wrist" built into the end of the surgical tools, give surgeons additional manipulation ability during minimal invasive laparoscopic surgery, enabling easier, more intricate motion and better control of surgical tools. The device is an alternative to traditional open surgery or minimally invasive manual laparoscopic surgery in an operating room environment for procedures such as gall bladder disease or gastro-esophageal reflux disease (severe heartburn).

DIGITAL MAMMOGRAPHY -- The Senographe 2000D Full Field Digital Mammography System, General Electric Medical Systems, is an x-ray mammography system that employs a digital receptor to capture images of the breast. These images can then be printed to film or displayed on a high-resolution workstation for interpretation by a qualified mammographer. The device passes x-rays through the breast to a receptor. In this case the receptor converts the received x-rays into digital signals that can be stored for subsequent retrieval and display. A mammographer then interprets the displayed image of the breast to determine whether the breast is normal or whether additional testing is required. This is an alternative to traditional screening and diagnostic mammography. It can be used whenever a traditional mammography examination is indicated.

MAPPING THE HEART AND TREATING ARRHYTHMIA – The NAVI-STAR® Diagnostic/Ablation Deflectable Tip Catheter, Biosense Webster, Inc., is a steerable, multi-electrode catheter with a deflectable tip. The catheter provides information for electrophysiological mapping of the heart and transmits RF (radiofrequency) current through the catheter tip electrode for ablation purposes. When used with the CARTO® system and REF-STAR® reference device, a real-time 3D reconstruction of the heart chamber is provided. For ablation, the catheter is used in conjunction with a compatible RF generator and a commercially available dispersive pad. The NAVI-STAR® catheter is available with either a thermocouple or thermistor temperature sensor embedded in the tip electrode. A magnetic field location sensor (location sensor) embedded in the tip transmits location information to the CARTOsystem. Thermal energy is delivered at the site of application, which produces a lesion that interrupts a defective electrical conduction pathway in the cardiac wall. The device and its related accessory devices are indicated for catheter-based atrial and ventricular cardiac mapping, and for cardiac ablation procedures

LASER-BASED EYE SURGERY – The Hyperion™ LTK System, Sunrise Technologies, International, Inc., is a new type of refractive surgical laser used in the temporary reduction of hyperopia (farsightedness). Its benefit is temporary because the amount of farsightedness correction decreases over time. However, some patients may retain some or all of the correction. LTK (Laser Thermal Keratoplasty) is a surgical treatment for farsightedness performed using a holmium YAG laser. The laser produces a beam that is positioned outside of the optical zone of the eye. The beam heats the tissue in the cornea, causing it to shrink slightly. When the tissue shrinks, the cornea angle becomes steeper. This allows incoming light to focus on the retina, giving clearer images. The goal of LTK is to improve the patient’s ability to see objects at a distance. This device may be used to treat patients who have farsightedness between +0.75 to +2.5 diopters (D), who are at least 40 years of age, and whose visual acuity has changed very little over time (that is, the patient’s glasses prescription has changed no more than 0.50 diopter in the previous six months). Treatment using this device will allow hyperopes (farsighted persons) who have difficulty seeing clearly at a distance without glasses to have improved distance vision without needing glasses.

TREATING GASTROESOPHAGEAL REFLUX DISEASE -- The CSM Stretta System, Conway Stuart Medical, Inc., is an electrosurgical system that includes a generator, electrosurgical catheter and a dispersive electrode. The electrosurgical catheter has a tip with individual needle prongs, which can be placed interstially into soft tissue to produce soft tissue coagulation. This system is intended for the treatment of Gastroesophageal Reflux Disease (GERD). The catheter tip needles are inserted into the soft tissue of the esophagus at the junction of the esophagus and stomach. Controlled energy is applied for a predetermined amount of time to produce soft tissue coagulation at the insertion site. This coagulation results in a shrinkage of the esophageal tissue at this site resulting in a narrowing of the junction which causes a reduction or elimination of stomach reflux of stomach acid up into the esophagus. This treatment can be used as an alternative to the previous surgical option of fundoplication. Fundoplication requires use of general anesthesia, a long recovery period and an extended hospital stay since it is major abdominal surgery. The Stretta process does not require general anesthesia and has significantly less recovery time or hospital stay time. Both of these procedures are used only after patients have failed more conservative treatments for GERD such as lifestyle changes, changes in diet, and use of medication to reduce production of stomach acid. Use of this surgical procedure can, in some patients, result in total elimination of reflux and use of GERD medications, and in other patients, surgery can result in improved pH values showing reduced acid problems and consequently allowing patients to use less costly or less potent GERD medications.

FDA Consumer Web Sites

Device Databases

Center for Devices and Radiological Health (CDRH) maintains searchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device.

Consumer Information

The Consumer Staff in FDA’s Center for Devices and Radiological Health, Division of Small Manufacturers Assistance also provides information to consumers regarding medical devices and radiation-emitting products to enhance their ability to avoid risk, achieve maximum benefit, and make informed decisions about the use of such products.

Website: http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/default.htm
E-Mail: dsma@cdrh.fda.gov
Phone: Toll Free 1-888-463-6332 or 301-827-3990 directly between the hours of
8:00 a.m. – 4:30 p.m. EST

The FDA Breast Implant website for consumer information is available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ BreastImplants/default.htm.

A new CDRH website entitled LASIK Eye Surgery: Learning About LASIK is available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/ LASIK/default.htm.