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FY 2001 ODE Annual Report - Part 1 — Advances in Patient Care

Cardiac Pacing To Treat Heart Failure

Pediatric External Defibrillator

Embolization Protection Device

Cable-Free Endoscopy

Intragastric Implant For Morbid Obesity

Glucose Monitoring Wrist Watch

Medical Devices With Sharps Injury Prevention Features

Periodontal Product

Hepatitis Tests

Implantable Middle Ear Hearing Device

Implant To Treat Glaucoma

Wound And Burn Dressing

Skin, Wound And Burn Dressing

FDA Consumer Web Sites

Publicly Available 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 under "Original PMA/HDE Approvals for Fiscal Year 2001." The Premarket Approval Application (PMA) approval website describing recently approved devices with patient information is available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm. Below we highlight several medical devices approved or cleared during this past fiscal year that we believe will have a major impact on patient care.

CARDIAC PACING TO TREAT HEART FAILURE - The InSync® Biventricular Cardiac Pacing System including the InSync® Model 8040 Pulse Generator and leads (Attain™ LV Model 2187 and CS Model 2188), Medtronic, Inc., is used to relieve some of the symptoms associated with moderate to severe heart failure in patients who also have an electrical disturbance in the heart that causes the ventricles not to contract at the same time and are not likely to improve with additional drug therapy. Heart failure is a condition where the heart cannot adequately pump blood around the body and may result in shortness of breath or fatigue during exertion. The InSync system consists of the Model 8040 Pulse Generator (which contains a battery and electronic circuitry) connected to three leads (insulated wires) that deliver electrical impulses to stimulate the heart. One lead is placed in an upper heart chamber (right atrium) and the two other leads are placed one in each of the ventricles. The Attain™ LV Model 2187 and CS Model 2188 are specially designed to be positioned within the heart's venous anatomy via the coronary sinus to achieve left ventricular pacing. The therapeutic effect is achieved by simultaneously stimulating the right and left ventricles. The InSync Pacing System is the first pulse generator approved for the treatment of heart failure.

PEDIATRIC EXTERNAL DEFIBRILLATOR -  The Heartstream FR2 AED with Attenuated Defibrillation Pads, Agilent Technologies, Inc. Heartstream Operation, is the first automatic external defibrillator cleared for use in children less than 8 years of age. It is used in infants and children as a life saving therapy if they suffer sudden death due to ventricular tachycardia or ventricular fibrillation. The Heartstream FR2 AED will be used in the public arena by trained first responder lay people. The device is a system composed of the FR2 pediatric pads and the defibrillator. The FR2 pads use a component (attenuator) in the connector that automatically absorbs energy from the electrical shock coming out of the AED. This results in delivery of a lower-energy shock that is directed at infants and small children. The reduced dose is 50 Joules instead of the standard 150 Joules usually delivered to adults. The availability of this technology may provide earlier recognition and treatment of ventricular fibrillation, which could in turn improve pediatric cardiac arrest survival rates. These patients can now receive a level of care equivalent to that of adults. Agilent Technologies Inc. will be performing an extensive post-market study to evaluate the use of the device.

EMBOLIZATION PROTECTION DEVICE — The PercuSurge Guardwire Plus, PercuSurge, Inc., of Sunnyvale, Calif., a division of Medtronic AVE, is an embolic protection system that is used during interventional cardiology procedures. The device is intended for use on patients who have previously had coronary bypass surgery and whose bypass vein graft has become blocked. These blockages require treatment such as insertion of a stent during angioplasty, which opens up a narrowed vessel. The PercuSurge device consists of a balloon catheter and aspiration catheter. The device is used during these procedures to collect and remove debris created by the interventional treatment thereby preventing blood clots from traveling into the blood stream. The debris--small blood clots, cholesterol crystals, and other particles--may cause serious problems, such as heart attack, if it is swept down the vein graft into the heart.

CABLE-FREE ENDOSCOPY — The Given Diagnostic Imaging System, Given Imaging Ltd., is a wireless, cable-free endoscopic imaging device that obtains video pictures from within the small intestine. The major component of the device is a 2.6cm x 1.1cm disposable capsule which contains a miniature metal oxide semiconductor imager, light emitting diode illuminators, and a transmitter with antenna. The capsule is ingested by a patient, traverses the small intestine with the aid of the natural peristaltic activity of the intestinal muscles, and is excreted intact through the rectum. The patient may continue his or her regular ambulatory activities while the capsule is moving through the body. During its passage through the gastrointestinal tract, the camera acquires and transmits images by way of radiofrequency to receiving antennas, which are attached to the patient's torso. The images are then transferred to a data storage component worn on a belt pack. They are later downloaded and viewed on a computer workstation for interpretation by a physician trained in endoscopy. This device is intended to be used as an adjunctive diagnostic tool in the detection of small bowel mucosal abnormalities.

INTRAGASTRIC IMPLANT FOR MORBID OBESITY — The LAP-BAND Adjustable Gastric Banding System, BioEnterics Corporation, is a surgically implanted device that includes a silicone elastomer band, access port and kink-resistant tubing. The system is intended for the treatment of severe obesity and is used to induce weight loss by limiting food consumption (restrictive rather than malabsorption). The silicone elastomer band is placed around the stomach to create a restricted opening, (stoma), and a small gastric pouch to limit food consumption and induce early satiety (feeling of fullness). The inner surface of the band is inflatable and connected by the kink-resistant tubing to the access port (a remote injection site). The access port allows non-surgical, percutaneous adjustments (through the surface of the skin) to the stoma diameter. Use of the Lap-Band System is an alternative to conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs and to other surgical options (gastric bypass and vertical banded gastroplasty). Use of this device may result in weight loss in severely obese patients.

GLUCOSE MONITORING WRIST WATCH — The GlucoWatch® Automatic Glucose Biographer from Cygnus, Inc., is the first glucose monitoring device that doesn't puncture the skin. Adult diabetics wear the device like a watch where a slight electric current pulls glucose through the skin. Glucose levels are automatically read and recorded every 20 minutes for up to 12 hours. Alarms warn users when high, low, or rapidly declining glucose levels occur. Readings are stored so that users can retrieve them at any time. Patients can better manage their diabetes because they receive information about patterns in their glucose levels. GlucoWatch® results may be similar to finger-stick test results taken at the same time, although some readings will differ significantly from finger-stick tests. GlucoWatch® does not replace finger-stick testing and is not for diabetics below the age of 18.

MEDICAL DEVICES WITH SHARPS INJURY PREVENTION FEATURES — These medical devices are designed with anti-stick characteristics to aid in the prevention of needlestick injuries. They may incorporate components such as retractable, shielded, blunted, or recessed needles. Other safety devices may include needleless systems such as pre-pierced septa and blunt cannulae and valved connectors (reflux valves). Examples of medical devices now available with a sharps injury prevention feature include: IV administration sets and accessories; piston syringes; hypodermic single lumen needles; IV catheters; blood collection devices; needleless access devices/systems; and vial adapters. Desirable characteristics may include: the device is needleless, the safety feature is an integral part of the device, the device preferably works passively, the user can easily tell if the feature is activated, the feature cannot be deactivated and remains protective through disposal, the device performs reliably, is easy to use and practical, and the device is safe and effective for patient care. A number of States recognize the importance of safety device use and have implemented regulations related to the use of these types of devices. During this fiscal year, General Hospital Devices Branch (GHDB) reviewed a total of 34 medical devices with sharps injury prevention features including 22 shielded needles, 8 needleless devices, and 4 retractable devices.

PERIODONTAL PRODUCT — The Emdogain, Biora, Inc., is a reformulation of a previously approved product that allows a change from the two-vial administration system to an easily applied gel-filled syringe application. Emdogain is approved to treat intrabony periodontal defects and as a topical application to exposed root surfaces where there is moderate to severe periodontal disease. Periodontal disease occurs in many adults and many surgical procedures are performed to treat this disease caused by accumulation of bacteria. The periodontal disease process can affect the gums (gingiva) and the bone that supports the teeth. This Biora product attempts to treat the disease process through a biological approach. This product contains amelogenin that is thought to have an important function in the creation of teeth and their support. Emdogain gel is used with periodontal surgery and leaves a resorbable protein matrix on the root surface. The new formulation allows the dentist to apply the gel without mixing and therefore decreases the time the patient must be in the dental chair.

HEPATITIS TESTS — The AMPLICOR™ and COBAS AMPLICOR™ Hepatitis C Virus tests, manufactured by Roche Molecular Systems, Inc., are the first tests approved by FDA for direct detection of hepatitis C virus RNA using nucleic acid amplification. These tests provide highly accurate results for detecting the virus and can establish whether the disease is active and requires treatment.


IMPLANTABLE MIDDLE EAR HEARING DEVICE — The Direct, Soundtec, Inc., is a surgically implanted hearing device intended to help adults with moderate to severe nerve hearing loss. The implanted portion of the device is a tiny magnet that is attached to one of the middle ear bones. It converts sound to mechanical energy that is directly transferred to the middle ear very much the way normal sound does. The brain interprets the vibrations as sound. This device is different from another implantable middle ear hearing device in that it is minimally invasive. The surgeon goes through the ear canal to place the implant in the middle ear. There are no external incisions. This device is an alternative to traditional hearing aids. Adults who choose this device should have already tried traditional hearing aids and not been satisfied with them.

— The AquaFlow Collagen Glaucoma Drainage Device, Staar Surgical Company, is used to treat open-angle glaucoma, a condition in which the intraocular pressure is abnormally high. If left untreated, glaucoma can cause blindness. The device is a small cylinder made of collagen. Implanted in the eye, it helps lower the pressure by absorbing excess fluid. The device is designed to maintain a space under the sclera (the white part of the eye). Once placed there, it swells as it absorbs fluid in the eye. This reduces pressure within the eyeball. Later, the device begins to slowly dissolve until it is completely absorbed within 6-9 months. It is the first device that has been approved for use when excess intraocular pressure cannot be completely controlled with medications. Previously cleared glaucoma devices are used only after medications and trabeculectomy surgery has failed. In addition to reducing intraocular pressure, it may allow patients to reduce the number of glaucoma medications they need to control their intraocular pressure.

WOUND AND BURN DRESSING — The OrCel™, Ortec International, is a bilayered cellular matrix in which normal human allogeneic skin cells (epidermal keratinocytes and dermal fibroblasts) are cultured in two separate layers into a Type I bovine collagen sponge and serves as an absorbable biocompatible matrix that provides a favorable environment for host cell migration. When OrCel™ is applied to a wound, it serves as a protective wound dressing and provides a favorable environment for the body's cells to grow and secrete various growth factors at the wound site that in turn aid in wound healing. Under the HDE program, OrCel™ is indicated for use in patients with recessive dystrophic epidermolysis bullosa after surgery to correct the "mitten" hand deformities through hand reconstruction. OrCel™ also received PMA approval for use in closure of split thickness donor site wounds in burn patients. During the autografting procedure, OrCel™ is placed on donor sites to cover the donor site wounds. As healing of donor site wounds in burn patients occurs, it is expected that OrCel™ will dissolve and the patients' own skin cells will replace the OrCel™ cells, creating a new intact skin surface.


SKIN, WOUND AND BURN DRESSING— The DERMAGRAFT®, Advanced Tissue Sciences, is a cryopreserved human fibroblast-derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold. It aides the closure of diabetic ulcers of greater than six weeks duration which extend through the dermis, but without tendon, muscle, joint capsule or bone exposure. DERMAGRAFT® should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot. 

This dressing can remain on a shelf up to six months when maintained at a temperature of -75°C ± 10° C. This is a major advantage over similar types of dressings since they usually have a shelf life of approximately five days.

DERMAGRAFT is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. DERMAGRAFT is contraindicated for use in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution.
FDA Consumer Web Sites

Publicly Available Device Databases

The Center for Devices and Radiological Health (CDRH) maintains electronic databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm. These databases are available in a searchable format to the public.

Consumer Information

The Division of Small Manufacturers International and Consumer Assistance (DSMICA) also provides information to consumers regarding medical devices and radiation-emitting products to enhance users' 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:   dsmica@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