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FY 2002 ODE Annual Report - Part 1 – Advances in Patient Care

Smallpox Vaccine Delivery System
Tuberculosis Test 
Glucose Monitoring Wrist Watch For Use In Children
Spinal Fusion Device
Hearing Aid
Neurological Stent For Aneurysms
Neurological Stent For Recurrent Intracranial Stroke
Testicular Prosthesis
New Type Of Defibrillator
Expandable Indication Of Defibrillator 
FDA Consumer Websites
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. Below we highlight several new medical devices and devices with new indications approved or cleared during this past fiscal year that we believe will have a particular impact on patient care.

For a complete listing of newly approved devices, please see Part 2 – INDUSTRY INFORMATION under “Original PMA/HDE Approvals for Fiscal Year 2002.” 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.

 SMALLPOX VACCINE DELIVERY SYSTEM – The bifurcated needle has been developed specifically as a biodefense tool for the delivery of smallpox vaccine. The bifurcated needle is a specialized high quality two-prong needle that replaced jet injectors that had been used in the early years for conducting vaccinations. Its unique features make it the appropriate medical device for either large-scale immunization campaigns or emergency response. These thin metallic rods are approximately 50 – 70 mm long and 1 mm wide, with one end flattened and formed into two sharp tines. The u-shaped gap between the tines of the needle, when dipped into reconstituted smallpox vaccine, holds the vaccine by capillary action. The needle penetrates the stratum corneum layer of the skin and delivers a small amount of vaccine to the deep epidermis. The General Hospital Devices Branch has cleared three 510(k)s for bifurcated needles.
 TUBERCULOSIS TEST – The QuantiFERON-TB from Cellestis Limited is the first in vitro test to detect cell-mediated immunity to Mycobacterium tuberculosis. The tuberculin skin test that has been used for over 50 years to detect cell-mediated immunity to M. tuberculosis is an in vivo test, requiring a repeat patient visit within 48-72 hours to read results. The QuantiFERON-TB assay on the other hand does not require a repeat visit to obtain results. It measures the release of IFN-g (gamma interferon) from lymphocytes in a whole blood sample during an overnight incubation with mycobacterial (PPD) and control antigens. It is indicated for testing individuals who originate from an area where tuberculosis is prevalent, or who are at increased risk by occupation or setting (e.g., healthcare workers, prisons, injection drug users). The assay is also indicated for testing population groups where the consequences of active infectious tuberculosis may be severe (military, healthcare workers, students at some institutions). Persons with a positive result may be at increased risk of subsequently developing active tuberculosis.
 GLUCOSE MONITORING WRIST WATCH FOR USE IN CHILDREN – The GlucoWatch G2 Biographer from Cygnus, Inc., is the first glucose monitoring device that doesn't puncture the skin that can be used by children, ages 7 and up, as well as adults. Diabetic children and adults wear the device like a watch where a slight electric current pulls glucose through the skin. Glucose levels are automatically read and recorded every 10 minutes for up to 13 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 measures glucose in interstitial fluid rather than in blood. Consequently, the GlucoWatch test results may sometime differ significantly from finger stick results. GlucoWatch does not replace finger stick testing.
 SPINAL FUSION DEVICE – InFUSE™ Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device by Medtronic Sofamor Danek is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1. The InFUSETM Bone Graft/Lt -Cage™ Lumbar Tapered Fusion Device is a spinal fusion device that does not require the use of autograft, a bone taken from the patient’s hip. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, function deficit and/or neurological deficit and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. InFUSE™ Bone Graft/Lt-CAGE™ devices are to be implanted via an anterior open or an anterior laparoscopic approach. Patients receiving the InFUSE™ Bone Graft/Lt-Cage™ Lumbar Tapered Fusion Device should have had at least six months of nonoperative treatment prior to treatment with the InFUSE™ Bone Graft/Lt-Cage™ Device.

The device consists of three components spilt among two parts – [part 1] a metallic tapered spinal fusion cage (known as the LT-CAGE Lumbar Tapered Fusion Device); and [part 2] a bone graft substitute (InFUSE Bone Graft) which consists of a genetically-engineered human cytokine (rhBMP-2) and a carrier/scaffold for the cytokine (manufactured from bovine [cow] Type I collagen), that is placed inside of the fusion cage. The fusion cage component maintains the spacing and temporarily stabilizes the diseased region of the spine, while the InFUSE Bone Graft component is used to form
bone which would permanently stabilize (fuse) this portion of the spine. The InFUSE Bone Graft component is used instead of the patient’s own bone (autograft bone).

 HEARING AID – The RetroX Transcutaneous Air Conduction Hearing Aid System, manufactured by Auric Hearing Systems, Inc., is a new type of hearing aid that works without plugging the ear canal. This hearing aid sends sound through a tube that a doctor has inserted through soft tissue between the back of the outer ear and the outer ear canal. It is used anytime the user wants to improve hearing. It should not be used if there is local inflammation or infection in the skin behind the ear or if there is injury to the ear that would make placement of the tube impossible.
 NEUROLOGICAL STENT FOR ANEURYSMS – Neuroform Microdelivery Stent by SMART Therapeutics, Inc. is intended for use with another medical device, embolic coils to treat patients with a certain kind of aneurysm in the brain who cannot be adequately treated by current surgical or endovascular techniques. The device consists of a self-expanding Nitinol mesh tube along with a microdelivery catheter. The stent is deployed across the neck of the aneurysm and embolic coils are placed through the struts of the stent into the aneurysm. The stent retains the embolic coils within the aneurysm, thus diverting the blood flow.

If left untreated or inadequately treated, wide neck aneurysms are at a high risk of rupture, resulting in a high risk of patient morbidity and mortality. The Neuroform™ Microdelivery Stent System is designed to address the limitations associated with the placement of coils in wide neck aneurysms.

 NEUROLOGICAL STENT FOR RECURRENT INTRACRANIAL STROKE – NEUROLINK® System by Guidant Corporation is composed of a Stent Delivery Catheter and a Balloon Dilatation Catheter. The NEUROLINK® System is indicated for the treatment of patients with recurrent intracranial stroke attributable to atherosclerotic disease. The device is a balloon expandable stainless steel mesh tube that is designed to open up the target blood vessel and provide structural support. The device is intended for patients who have >= 50% stenosis in the target intracranial vessels, leading to reduced blood flow to the brain with accompanying neurological symptoms. The Balloon Dilatation Catheter allows the physician to open up narrowed atherosclerotic areas in the blood vessel prior to placement with the stent. The NEUROLINK® System is the first device approved to treat these patients.
 TESTICULAR PROSTHESIS – The Mentor Saline-Filled Testicular Prosthesis, manufactured by Mentor Corporation, is an oval, silicone elastomer device that is designed to approximate the weight, shape, and softness of the normal testicle. This device is implanted in the scrotum in males who desire cosmetic replacement of a missing testicle, and consists of a silicone elastomer shell with an injection port and recessed suture tab. Although the implanted device looks and feels like a natural testicle, it does not have any other function. The Mentor Saline-Filled Testicular Prosthesis is manufactured in four sizes to accommodate juvenile to adult anatomies. The device is packaged empty, and filled with sterile saline at the time of implantation.
 NEW TYPE OF DEFIBRILLATOR – The Contak CD CRT-D by Guidant Corporation is a new type of implantable cardioverter defibrillator (ICD) that also has the ability to deliver cardiac resynchronization therapy. The device, the first of its kind, can be used to treat symptoms of advanced heart failure in certain people who already need an ICD. The device combines an implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT). The defibrillator component detects and treats life-threatening heart rhythms. The CRT component coordinates the beating of the left and right ventricles of the heart so that they work together more effectively to pump blood throughout the body. The device is intended to treat people who already need an implantable defibrillator, whose heart timing is off and who, despite taking heart failure medication, have symptoms of advanced heart failure, such as fatigue, shortness of breath and difficulty performing daily activities.
 EXPANDABLE INDICATION OF DEFIBRILLATOR – A new use was approved for the Ventak automatic implantable cardiac defibrillator by Guidant Corporation so that it can now be used prophylactically in many people who have had a previous heart attack and an ejection fraction <= 30%. Ejection fraction is a measure of how efficiently the heart pumps blood. A level of 30% or less is an indication of impaired function that puts heart attack survivors at increased risk for sudden cardiac death. The expanded indication is based on results from the MADIT II trial. The trial showed that use of these devices reduced total mortality by 31% for heart attack survivors with compromised heart function.
 WEARABLE DEFIBRILLATOR - The wearable cardioverter defibrillator (WCD®) by Lifecor, Inc. is used by adult patients 24 hours a day to monitor and treat dangerous, abnormally fast heart rhythms. These abnormal rhythms lead to a complete absence of heart beat (sudden cardiac arrest) and death (sudden cardiac death) if they are not treated. The WCD is a combination of two different devices. As a cardioverter, it uses low-energy electrical shocks to return an abnormally fast heart beat (ventricular tachycardia, or "VT") to a normal rhythm. As a defibrillator, it uses high-energy shocks to return a very fast, disordered heart beat (ventricular fibrillation, or "VF") to a normal rhythm. The Wearable Cardioverter Defibrillator (WCD) does the same job as an implantable cardioverter defibrillator (ICD). The difference is that the WCD is non-invasive, which means that it requires no surgery, implantation, or entry into the body. Instead, patients wear a vest-like garment that holds the WCD parts - a monitor, electrodes, and small "alarm module." The WCD is fully automatic and requires no patient action to deliver treatment - but the patient is able to prevent treatment if it is not needed. The WCD® device is worn if a patient is at risk of sudden cardiac arrest and an implantable defibrillator is not wanted or is not practical.

 FDA Consumer Websites

 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
Fax:
301-443-9535