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FY 2004 ODE Annual Report - Part 1 – Advances in Patient Care

Expandable Prosthetic Rib
Rechargeable Spinal Cord Stimulator
Dermal Filler
Carotid Stent System
Drug Coated Stent
Implantable Therapy Defibrillators
Home Defibrillator
Heart Assist Device For Children
Capsular Tension Ring (CTR)
Accommodating Posterior Chamber Iol
Phakic Intraocular Lens (PIOL)
Image Analysis System
FDA Consumer Websites
Publicly Available Device Databases
Consumer Information

 

Part 1 – Advances in Patient Care

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 2004.” 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.

Expandable Prosthetic Rib - Picture of two curved metal rods with hooks at each end Expandable Prosthetic Rib – The Vertical Expandable Prosthetic Titanium Rib (VEPTR) by Synthes (USA) was approved as a Humanitarian Use Device for conditions afflicting less than 4000 patients a year. VEPTR device is the first implant intended to treat Thoracic Insufficiency Syndrome (TIS) in skeletally immature pediatric patients. TIS is a congenital condition where severe deformities of the chest, spine, and ribs prevent normal breathing and lung growth and development. The VEPTR device is a curved metal rod that is attached to ribs near the spine using hooks located at both ends of the device.

The VEPTR device helps straighten the spine and separate ribs so that the lungs can grow and fill with enough air to breathe. During surgery, the VEPTR device is adjusted to fit the patient and attached vertically on the patient’s ribs near the spine. Lengthening the device enlarges the rib cage and increases the amount of lung space in the patient’s chest. The VEPTR device will be lengthened or replaced at specific times to allow for the patient’s growth and to further correct spinal or chest wall deformity. Adjustments to the length of the VEPTR device are made during surgery through a small cut (incision) in the patient’s back. Use of the VEPTR device in skeletally immature pediatric patients may result in:

• a more normal growth pattern without spinal growth limitations,
• decreased chest, spine and rib deformity,
• expanded lung volume, and
• decreased dependence on a supplemental air supply.

 

Rechargeable Spinal Cord Stimulator - Picture of oval shaped metal signal generator with two insulated lead wires Rechargeable Spinal Cord Stimulator Precision Spinal Cord Stimulator by Advanced Bionics is the first rechargeable implanted spinal cord stimulator which should require fewer replacement surgeries due to limited battery life. The PRECISION™ Spinal Cord Stimulator (SCS) System is a neurostimulation device that transmits electrical signals to the spinal cord to decrease chronic pain in the body, arms and legs.

The device consists of two parts: a stimulator device (signal generator) implanted under the skin that transmits electrical signals to the spinal cord through an insulated lead wire, and an external remote control that programs the treatment delivered by the signal generator. The implanted signal generator receives radio signals from the remote control.

 
The radio signals tell the signal generator when and what kind of stimulation to deliver to the spinal cord. The external remote control is battery operated and can be controlled by the patient or a health care provider. The Precision™ SCS System is used as an aid in the management of: difficult to treat chronic pain of the body and limbs, pain associated with failed back surgery syndrome, low back pain, and leg pain.
Dermal Filler - Picture of two test tubes half way filled with acid Dermal Filler – Sculptra Injectable filler by Dermik Laboratories is the first approved treatment for the effects of lipoatrophy (facial fat loss) in persons with HIV. The changes in facial appearance as a result of lipoatrophy are one of the stigmatizing side effects of the drugs used to treat HIV. Sculptra is a dermal filler made from absorbable poly-L-lactic acid (PLA). Sculptra was shown to produce significant increases in skin thickness, adding volume to facial tissue and restoring shape in areas of the face with fat loss. Studies reported an improvement in the quality of life among those treated and less of the anxiety and depression often associated with lipoatrophy.  
Carotid Stent System - Picture of cylinder shaped mesh and guidewire Carotid Stent System – The Acculink™ Carotid Stent System from Guidant was approved for use in opening blocked arteries in the neck. The new stent is intended to prevent stroke by treating blockages in the carotid artery, the main blood vessel leading to the brain. The device was approved for use in patients who have had symptoms of a stroke, or whose neck blood vessels are at least 80 percent blocked, and who are not good candidates for the surgical alternative.  
  Carotid Stent System - Picture of cylinder shaped mesh and guidewireThe Acculink™ Carotid Stent System was approved with the Accunet™ Embolic Protection Device (K042218) also from Guidant Corporation. The Accunet device is a filter device that opens up like an umbrella. It has small holes to allow blood to flow through, but small enough to catch any particles that may break off from the blockage during the stenting procedure.
 Drug Coated Stent – The TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent by Boston Scientific Corporation, is an expandable, slotted, stainless steel tube, with a drug (paclitaxel) contained within a thin polymer coating on its surfaces. The Stent is mounted over a deflated balloon attached to the end of a long thin flexible tube (stent delivery catheter). The Stent is used in patients who have a narrowing in their coronary arteries (blood vessels supplying blood to the heart) caused by atherosclerosis -- the collection of fatty substances such as cholesterol that forms “plaque” along the lining of the arteries. The TAXUS Express Stent should not be used in patients:
Drug Coated Stent - Picture of a long, thin flexible tube with a deflated balloon attachment

• who cannot take aspirin or blood-thinning medicine,

• who have an allergy to the drug paclitaxel, related drugs, 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 or proper placement of the stent.

Implantable therapy Defibrillators - Picture of two oval pulse generators Implantable Therapy Defibrillators – The Guidant CONTAK CD, CONTAK CD2, RENEWAL, and RENEWAL 3 are implantable cardioverter defibrillators (ICDs) that also deliver cardiac resynchronization therapy (CRT). These ICDs use small electrical impulses to coordinate heart rhythm and improve blood pumping ability in certain patients with moderate to severe heart failure. A Guidant Cardiac Resynchronization Therapy Defibrillator (CRT-D) consists of an implantable pulse generator (IPG), made up of a battery and electronic circuitry, connected to three leads (insulated wires).The IPG is usually implanted below the collarbone, just beneath the skin. When the device is functioning as an ICD, it senses dangerous abnormal heart rhythms and attempts to shock the heart back into a normal rhythm.  

The CRT portion of the device coordinates the beating of the left and right ventricles so that they work together more effectively to pump blood throughout the body. A Guidant CRT-D is used in certain patients who have:

• symptoms of advanced heart failure despite taking heart failure medication, and
• a heart rhythm problem (arrhythmia) that may cause the lower chambers of the heart to beat in an uncoordinated manner.

A Guidant CRT-D is indicated for patients with moderate to severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal heart failure drug therapy, and have left ventricular dysfunction (EF </= 35%) and QRS duration >/= 120 ms.
A Guidant CRT-D will deliver:

• CRT to help coordinate the beating of the heart, and
• a life-saving shock to attempt to return the heart to normal heart rhythm.

Together, these two therapies may reduce the combined risk of death or first hospitalization as well as the risk of death alone. It may also relieve some of the symptoms associated with heart failure, including shortness of breath and fatigue during exercise, which may result in a better quality of life.

 

 Home Defibrillator – The HeartStart Home Defibrillator by Philips Medical Systems is a small, lightweight automatic external defibrillator (AED) specifically designed for home use without a prescription. HeartStart is a battery-powered device that delivers an external electric shock through the patient’s chest to help restore a normal heart rhythm. It is intended to treat a person who experiences sudden cardiac arrest caused more frequently by ventricular fibrillation. During ventricular fibrillation, the electrical signals in the lower part of the heart are uncoordinated and ineffective. Very little blood is pumped from the heart to the body or the lungs. If ventricular fibrillation is not treated it will result in death. The HeartStart Home Defibrillator can be used on an adult or child who:

• is 8 years of age or older,
• weighs at least 55 pounds,
• is in sudden cardiac arrest,
• does not respond when shaken, and
• is not breathing normally.

Special adhesive pads for use on infants and young children are available by prescription.

HeartStart is designed for consumer use in the home. CPR training is recommended for anyone who may use the HeartStart.

Home Defibrillator - Picture of square red carrying case and a picture of boxed shape blue automatic external defibrillator
Picture of human heart with titanium pump attached to the ventricular apex and the aorta

 Heart Assist Device for Children - The DeBakey VAD Child Left Ventricular Assist System by MicroMed Technology, Inc. was approved as a Humanitarian Use Device for pediatric patients with end-stage left ventricular failure requiring temporary mechanical circulatory support as a bridge to cardiac transplantation. It is estimated that fewer than 100 children a year will be candidates for this new device. The Debakey VAD Child is the first device approved for children with severe left ventricle failure. The device is a miniaturized, implantable, titanium, axial flow pump for children aged 5 to 16 with a body surface area between 0.7m2 and 1.5m2.

A titanium inflow cannula connects the pump to the ventricular apex and a Vascutek Gelweave vascular graft (outflow conduit) connects the pump to the aorta. A cable assembly attached to the pump exits the right frontal portion of the body and attaches to an external controller system. This controller provides energy to the device causing it to pump blood. The controller is always connected to the batteries and may be connected to an external power supply.

The DeBakey VAD Child should not be used in pediatric patients:
• who are under 5 years of age,
• who have a body surface area less than 0.7m2,
• who suffer from right ventricular failure unresolved by medical therapy,
• who have primary coagulopathy or platelet disorders, or
• who have an allergy or sensitivity to Heparin.
Capsular Tension Ring (CTR) - Picture of circular shaped plastic ring with holes at each end  Capsular Tension Ring (CTR) Morcher Capsular Tension Ring (CTR) manufactured by Morcher GmbH is the first CTR approved to help cataract surgeons place and center an intraocular lens (an artificial lens) in adult patients undergoing cataract surgery (a procedure to remove the clouded natural lens) and who have weakened or missing zonules (thin tissue fibers that hold the lens in place). Conditions associated with weak or missing zonules may include Marfan’s Syndrome, Marchesani’s Syndrome, trauma, etc.
The CTR is a plastic ring circular in design; however, the circle is not complete due to positioning holes placed at the ends to help the surgeon position the device correctly in the capsule bag of the eye. The device is available in three sizes 14, 14A and 14C.
 Accommodating Posterior Chamber IOL – Crystalens (Model AT-45) manufactured by Eyeonics is the first accommodative intraocular lens (IOL). The Crystalens is a modified plate haptic lens with polyimide loops and hinges across the plates next to the optic. The IOL is intended to be implanted in adults for the visual correction of aphakia (absence of the natural crystalline lens) and to provide near, intermediate, and distance vision without spectacles and approximately one diopter of monocular accommodation.
Accommodating Posterior Chamber IOL - Picture of circular shaped lens with a plastic plate and hoops and hinges on each side
The exact mechanism of action is unknown; however, the lens design is to move back and forth along the axis of the eye in response to the movement of eye muscles thereby helping patients focus on objects.
 Phakic Intraocular Lens (PIOL) - The ARTISAN® (Model 206 and 204) phakic intraocular lens (PIOL) manufactured by Ophtec is the first PIOL. This type of lens is called a PIOL because the eye still has its natural lens. The ARTISAN® PIOL is a permanently implanted plastic lens with haptics designed to attach to the iris. The ARTISAN® PIOL is intended to reduce or eliminate moderate to severe nearsightedness (myopia) ranging from -5.0 to -20.0 diopters (D) in patients aged 21 and over with less than or equal to 2.5 D of astigmatism, an anterior chamber depth greater than or equal to 3.2 millimeters, and a stable refraction (determined by an ophthalmologist).
Phakic Intraocular Lens - Picture of circular shaped lens

The ARTISAN® PIOL works by bending (refracting) light rays to allow them to focus on the retina.

Ophtec manufactures and distributes the lens under the trade name ARTISAN™ in all markets except North American and Japan. Advance Medical Optics (AMO) will distribute the device in North America and Japan under the name of Verisyse (Model VRSM5US and VRSM6US).

 Image Analysis System – The ImageChecker® CT System by R2 Technology, Inc. is an image analysis system used by a radiologist to review Computed Tomography (CT) images of the chest. The system can help identify pulmonary nodules that a radiologist may have missed. The ImageChecker® CT System uses Computer Aided Detection (CAD) software to analyze CT images that a radiologist has reviewed. Following the radiologist’s review of the case the software reviews the CT images to highlight suspect nodules (areas of interest) that he or she may have missed.
Image Analysis System - Picture of a patient laying on bed designed to move into an opening which is attached to a donut shaped device and flow diagram of computer work station

 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.

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