FY 2003 ODE/OIVD Annual Report - Part 1 – Advances in Patient Care
Left Ventricular Assist Device (LVAD)
Drug-Eluting Stent
Sterilization Procedure For Women
Fibroid Embolization
Limb Salvage System
Deep Brain Stimulator
Stair Climbing Wheelchair
External Insulin Pump
A1c Now For Home Use
Bayer Advia Centaur Serum Her-2/Neu Assay
Invasive Fungal Infection
West Nile Virus Infection
Diagnosis Of Congestive Heart Failure
Ruling Out Heart Attack
Monitoring Asthma Better
Predicting Coronary Heart Disease
FDA Consumer Websites
Publicly Available Device Databases
Consumer Information
Last year the Office of Device Evaluation (ODE) and the Office In Vitro Diagnostic Device Evaluation and Safety (OIVD) 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 2003.” 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.
Office of Device Evaluation
| LEFT VENTRICULAR ASSIST DEVICE (LVAD) – HeartMate® SNAP-VE LVAS (Sutures Not Applied-Vented Electric Left Ventricular Assist System) by Thoratec Corporation is the first LVAD approved for long term implant. It was originally approved for use as a bridge to cardiac transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. It is now also approved for use in patients who are not eligible for cardiac transplantation with New York Heart Association Class IV end stage left ventricular failure who have received optimal medical therapy for at least 60 of the last 90 days, and who have a life expectancy of less than two years. The device system is approved for use both inside and outside of the hospital. |
| DRUG-ELUTING STENT – CYPHER™ Sirolimus-eluting Coronary Stent by Cordis Corporation is the first drug-eluting stent for angioplasty procedures to open clogged coronary arteries. The device is an expandable, slotted, stainless steel tube, with a drug (sirolimus) contained within a thin polymer coating on its surfaces. |
| The Stent is mounted over a balloon on the end of a long thin flexible tube called a “delivery catheter” (RAPTOR™ Over- the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System). This new stent slowly releases a drug, and has been shown in clinical studies to significantly reduce the rate of re-blockage that occurs with existing stents. The device should not be used in patients: who cannot take aspirin or blood-thinning medicine, who have an allergy to the drug sirolimus, its derivatives or the polymers used to coat the stent, or who have a blockage in the coronary artery that will not allow complete inflation of the balloon. |
| STERILIZATION PROCEDURE FOR WOMEN –The Essure™ System by Conceptus, Inc. is a new method of permanent birth control (sterilization) for women. Unlike other sterilization procedures for women, this system does not require incisions or general anesthesia. |
| Instead, a doctor implants small metal coils in a woman’s fallopian tubes by threading them through the vagina and uterus using a specialized delivery catheter. After the catheter is removed, the coils remain in place permanently. Over time, scar tissue forms around the implanted coils and blocks the fallopian tubes, preventing sperm from fertilizing a woman’s eggs. Initial one and two year data from clinical studies showed no pregnancies at the time of approval. Longer term data will be available over time with postmarket follow-up of these patients. |
| FIBROID EMBOLIZATION – Uterine Fibroid Embolization by Biophere Medical, Inc. is the first 510(k) cleared for Uterine Fibroid Embolization (UFE). It is indicated to treat symptomatic fibroids (noncancerous tumors). A radiologist makes a small nick in the skin (less than one-quarter inch) and inserts a thin tube (catheter) into the main artery of the thigh (femoral artery). |
| Using X-ray imaging, the radiologist guides the catheter through the femoral artery into the uterine artery. Tiny spheres or particles made of plastic or sponge material the size of grains of sand are pumped through the catheter into the uterine artery on one side of the body, where they block the blood supply to the fibroids. The procedure is then repeated on the other side of the body so the blood supply is blocked in both the right and left uterine arteries. With decreased blood supply, part of the fibroid tissue dies. The overall effect is shrinking of the fibroid. |
| LIMB SALVAGE SYSTEM – Children who require replacement of their knee joints often lose the ability for growth in the affected limb. This necessitates several surgeries throughout childhood and adolescence to expand the child’s prosthesis as the child grows to maintain limb length equality. |
| The REPIPHYSIS™ Limb Salvage System, manufactured by Wright Medical Technology, Inc., is an artificial knee joint with a unique femoral component that can be expanded without surgical intervention. The device utilizes a coil that fits around the patient’s leg that produces an electromagnetic field (EMF). The EMF induces an electrical current and subsequent heating of an internal wire. The generated heat softens a polymer locking ring, allowing a slow expansion of an internal compressed spring. The spring expansion pushes the spring housing and femoral housing apart, thus increasing the overall length of the implant. |
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DEEP BRAIN STIMULATOR – Medtronic Activa® Dystonia Therapy is a totally implanted brain stimulator to treat long-term primary dystonia (abnormal contraction of muscles at rest) that is not responsive to drug therapy.
An implanted pulse generator (IPG) is connected with a lead (insulated wire) extension, to another lead with four electrodes. The electrodes are in contact with a specific structural area within the brain. The IPG is implanted under the skin of either the abdomen or under the collar bone, and sends programmable electrical stimulation pulses to the electrodes that were implanted in the brain. Two IPG device systems may be implanted, so that both sides of the brain can be stimulated to relieve symptoms on both sides of the body.
It may improve some symptoms associated with primary dystonia. However, individual results vary and the specific benefit for an individual cannot be predicted.
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| STAIR CLIMBING WHEELCHAIR - The INDEPENDENCE™ iBOT™ 3000 Mobility System by Independence Technology, L.L.C. is a new indoor/outdoor power mobility device for use by people with mobility impairments and the use of at least one upper extremity. It provides mobility on smooth surfaces and inclines at home and in the community; movement over obstacles, uneven terrain, curbs, grass, gravel, and other soft surfaces; mobility in a seated position at an elevated height; ascent or descent of stairs with or without assistance; and transport of the unoccupied wheelchair. Because of its unique balancing mechanism, the device remains stable and the seat stays level under most conditions. The iBOT™ is available by prescription only, from specially trained health professionals. |
| EXTERNAL INSULIN PUMP – The Medtronic MiniMed Paradigm Model 512 Insulin Pump and BD Paradigm Link Glucose Monitor by Minimed, Inc. is an ambulatory, battery operated, rate-programmable microinfusion pump. The Model 512 Insulin Pump is indicated for the continuous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. The BD Paradigm Link Blood Glucose Monitor is an in-vitro diagnostic device intended to be used for the quantitative measurement of glucose in whole blood samples obtained from the fingertip, by people with diabetes mellitus in the home, as an aid to monitor the effectiveness of diabetes control. |
| When used together, the glucose monitor can automatically telemeter glucose values to the insulin pump using radio frequency communication. The glucose monitor can also serve as a radiofrequency interface to allow communication between the insulin pump and a personal computer running the appropriate Medtronic MiniMed communications software. |
Office of In Vitro Diagnostic Device Evaluation and Safety
| A1C NOW FOR HOME USE – December 13, 2002, FDA cleared the A1C Now for Home Use device. This device provides a quantitative measurement of the percent of glycated hemoglobin levels in capillary blood samples. This test is used at home by patients who have diabetes to monitor long term glycemic control. |
| BAYER ADVIA CENTAUR SERUM HER-2/NEU ASSAY – January 30, 2003, FDA cleared the Bayer Advia Centaur serum Her-2/neu assay used in the follow-up and monitoring of patients with metastatic breast cancer whose initial serum Her-2/neu level is greater than 15 ng/ml. Her-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the measurement of Her-2/neu in serum as a prognostic indicator for early recurrence and in the management of patients on immunotherapy has not been fully established. |
| INVASIVE FUNGAL INFECTION – May 16, 2003, FDA cleared The Platelia® Aspergillus EIA test, manufactured by Bio-Rad Laboratories. This is the first rapid laboratory test to detect Aspergillus galactomannan antigen in blood, as an indicator of invasive infection. The test will help doctors diagnose invasive Aspergillus infection, a life-threatening invasive fungal infection that often occurs in leukemia patients, organ and bone marrow transplant patients, and patients whose immune systems are compromised by illness or chemotherapy, much sooner than current laboratory methods. Results are available in about three hours. By comparison, the standard culture method of testing for Aspergillus takes a minimum of four weeks before results are available. Earlier detection means earlier intervention with life-saving treatment for these critically ill patients. |
WEST NILE VIRUS INFECTION – July 3, 2003, FDA cleared the West Nile Virus IgM Capture ELISA test, manufactured by PanBio, Limited. This is the first test for use as an aid in the clinical laboratory diagnosis of West Nile Virus infection. The test is intended for use in patients with clinical symptoms consistent with encephalitis. West Nile virus is a mosquito-borne flavivirus that until 1999 was found only in the Middle East, Eastern Europe and Africa. The disease first appeared in the United States in 1999 and in 2002 over 3300 cases were identified. Transmission to humans is primarily by mosquito. While the virus often presents as a mild infection that clears without further treatment, some patients develop severe infection resulting in severe neurological disease and even death. Antibodies for IgM can be seen within the first 1 to 8 days after onset of disease and can assist in the diagnosis of these patients. The disease is most prevalent during the mosquito season which is expected to begin in July and end in October. Over the past several years, the geographic range of the virus as well as the number of new infections has expanded and now covers most of the continental United States. This test will be of use in helping to diagnose this growing public health problem.
| DIAGNOSIS OF CONGESTIVE HEART FAILURE – November 19, 2002, FDA cleared the Elecsys proBNP Immunoassay test. This test is a first-of-a-kind fully automated test for diagnosing congestive heart failure. The automation allows the laboratory to run a higher volume of samples, making the test more readily available to patients who need it. The Elecsys proBNP Immunoassay test is made by Roche Diagnostics, Inc., of Indianapolis, Indiana and is run on the Roche Diagnostics Elecsys Analyzers. The test detects the level of a peptide, NT-proBNP, which is secreted almost exclusively by the heart. An elevated level can indicate the presence of congestive heart failure. The higher the blood levels of proBNP, the more serious the condition. FDA cleared the first laboratory test for use as an aid in diagnosing congestive heart failure, the Biosite Diagnostics Triage BNP test in November 2000. The test can help doctors differentiate between congestive heart failure and other problems, such as lung disease. Early detection of congestive heart failure is important because, if detected early, it can often be managed with medication. |
| RULING OUT HEART ATTACK – February 14, 2003, FDA cleared the Albumin Cobalt Binding Test (ACB Test). This test is a new first-of-a-kind blood test that measures Ischemia Modified Albumin (IMA). IMA helps in determining that a patient has NOT had a heart attack when he or she presents to an emergency room with severe chest pain. The ACB Test is manufactured by Ischemia Technologies Inc., of Arvada, Colorado. It uses human serum and detects IMA by measuring how much cobalt is bound to the blood protein albumin. The ACB Test works by detecting albumin levels. |
| A cobalt solution is added to serum and the unbound cobalt is detected by a color indicator. In the serum of normal patients more cobalt is bound to albumin leaving less cobalt to be detected by the color indicator, and forms less color. In patients with non-normal albumin levels, less cobalt is bound to albumin, which leaves more free cobalt to react with the color indicator, forming more color. The ACB Test is used as an additional test with both electrocardiogram (ECG) and another chemical marker--Troponin. ACB is not intended for use as a stand alone heart attack test. A normal ACB Test with a normal ECG, and a normal Troponin, gives doctors more confidence that patients can go home because they did not have a heart attack. |
MONITORING ASTHMA BETTER – April 30, 2003, FDA cleared the Nitric Oxide (NIOX) Test System. This test is a first of a kind, non-invasive test system to measure the concentration of nitric oxide in exhaled human breath. The test system helps make it easier for doctors to monitor a patient's asthma. The NIOX Test is manufactured by Aerocrine AB of Sweden. It combines equipment that detects nitric oxide and equipment that analyzes exhaled breath with a special computer system. To use the device, a patient places the mouthpiece over his or her mouth. The mouthpiece is connected to the equipment and the computer. Patient inhales nitric oxide-free air to total lung capacity, and then slowly exhales into the mouthpiece. The nitric oxide concentration is then displayed immediately on the computer screen. Doctors can use the device in their office to evaluate their patient's response to anti-inflammatory treatment.
| PREDICTING CORONARY HEART DISEASE – July 18, 2003, FDA cleared the PLAC Test. This test is a first of a kind, laboratory blood test that will increase the ability of doctors to predict the risk of coronary heart disease (CHD). The PLAC test is manufactured by diaDexus, Inc. of San Francisco, California. The test works by measuring an enzyme called lipoprotein-associated phospholipase A2. This enzyme is made by a type of white blood cell called a macrophage. Macrophages make more of this enzyme and release it into the blood when a person has CHD. The test provides supportive information when used with clinical evaluation and other tools for patient risk assessment. An elevated PLAC test result with an LDL-cholesterol less than 130 mg/dL gives doctors increased confidence that patients have 2 to 3 times the risk of CHD when compared with patients having lower PLAC test results. |
FDA Consumer Websites
Publicly Available Device Databases
The Center for Devices and Radiological Health (CDRH) maintains a website with additional consumer information about medical devices at http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/default.htm. This website appears in a searchable format for 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.
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