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FY 2005 ODE Annual Report - Part 1 - Advances in Patient Care

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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.

New technology for destruction of uterine fibroids

Image of ExAblate 2000 System The ExAblate 2000 System by InSightec, Ltd. uses magnetic resonance image guided focused ultrasound to target and destroy uterine fibroids. The device is intended to treat women who have completed child bearing or do not intend to become pregnant.

The ExAblate provides a uterine-sparing alternative for women experiencing problems from uterine fibroids using a non-invasive surgical treatment. The ExAblate combines two systems: 1) a magnetic resonance imaging (MRI) device to visualize patient anatomy, map the volume of fibroid tissue to be treated, and monitor the temperature of the uterine tissue after heating, and 2) a focused ultrasound beam that heats and destroys the fibroid tissue using high frequency, high-energy sound waves. This is the first time these two systems have been combined and the first time MRI has been used to monitor tissue temperature. The treatment requires repeated targeting and heating of fibroid tissue while the patient lies inside the MRI machine. The procedure can last as long as three hours.

DuraSeal Dural Sealant System

The DuraSeal Dural Sealant System The DuraSeal Dural Sealant System by Confluent Surgical, Inc. is the first material approved for sealing leaks in the dura mater during neurosurgical procedures. The sealant is composed of two solutions, a polyethylene glycol (PEG) ester solution and a trilysine amine solution referred to as the blue and clear precursor solutions. When mixed together, the precursors provide rapid in situ polymerization to form a hydrogel that seals the dura mater. DuraSeal Dural Sealant is intended to aid in preventing cerebrospinal fluid leakage through suture-approximated wound edges. The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place. The blue colorant allows users to easily visualize application of the sealant. The sealant is absorbable and will biodegrade within 4-8 weeks after application.

CHARITÉ™ Artificial Disc

CHARITÉ™ Artificial Disc The CHARITÉ™ Artificial Disc by DePuy Spine, Inc. is the first non-fusion device intended to replace a diseased or damaged intervertebral disc (spinal arthroplasty) to treat pain associated with degenerative disc disease (DDD). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies.The CHARITÉ™ consists of two metal (cobalt-chrome alloy) endplates that are anchored to the top and bottom surfaces of the spinal bones (vertebrae) and a plastic (ultra-high molecular weight polyethylene or UHMWPE) core that fits between the two endplates. The plastic core and endplates help restore the natural distance between the two vertebrae (disc height). The endplates can slide over the domed parts of the core, which can allow movement at the level where it is implanted. The CHARITÉ™ Artificial Disc is indicated for spinal arthroplasty in patients who are skeletally mature, have DDD at one level in the lumbar spine (from L4-S1), have no more than 3mm of spondylolisthesis at the involved level, and have had no relief from pain after at least six months of non-surgical treatment.

New lead wire for pacemakers

Medtronic SelectSecure, lead wire for pacemakers The Medtronic® SelectSecure™ Lead Model 3830, manufactured by Medtronic, Inc., is a surgically implanted wire that connects the heart to an implanted pacemaker. A pacemaker is a small, battery-operated electronic device which is inserted under the skin to help the heart beat regularly and at an appropriate rate. The SelectSecure™ Lead Model 3830, in conjunction with an implanted pacemaker, treats irregular or slow heart rhythm (bradycardia). If bradycardia is not treated, it can lead to fatigue, shortness of breath, dizziness, or fainting. The SelectSecure™ Lead Model 3830 allows a pacemaker to monitor and pace the heart and slowly releases a steroid (Beclomethasone Dipropionate) into the body to improve healing of the lead attachment site after implantation. The SelectSecure™ Lead Model 3830 is used when implantable atrial or ventricular, single-chamber or dual-chamber pacing systems are indicated.

New endovascular graft for treatment of aneurysms

GORE TAG Thoracic Endoprosthesis (a prosthetic endovascular graft) The GORE TAG Thoracic Endoprosthesis (a prosthetic endovascular graft) by W.L. Gore & Associates is used to repair aneurysms of the aorta in the chest (thoracic aorta). An aneurysm is a diseased, weakened and bulging section of an artery wall. The GORE TAG Thoracic Endoprosthesis is an endovascular graft made of ePTFE (expanded polytetrafluoroethylene), with a metallic support structure known as a stent. The endovascular graft is placed inside the weakened artery to prevent further growth and rupture of the aneurysm. The GORE TAG Thoracic Endoprosthesis is the first endovascular grafting system approved to treat aneurysms of the thoracic aorta. The GORE TAG Thoracic Endoprosthesis is used instead of more invasive open surgery in patients who have a descending thoracic aortic aneurysm.

Stent for prevention of future strokes

Xact ® Carotid Stent SystemThe Xact ® Carotid Stent System by Abbott Vascular Devices is used in high risk carotid disease patients with either symptomatic carotid vascular disease and a >50% carotid blockage or in patients with a very tight blockage (>80%) in their carotid artery as an alternative to the surgical procedure known as carotid endarterectomy.

The Xact® Carotid Stent System has two components: the stent and delivery catheter system (Xact® Carotid Stent System) and an embolic protection system (Emboshield Embolic Protection System). The Xact® Carotid Stent System is intended to open blockages in the carotid blood vessel in order to prevent future strokes. The embolic protection device is intended to capture debris that may be dislodged during placement of the stent.

New technology for maintaining patient data

VeriChip ™ Health Information Microtransponder System, consisting of an implantable chip, an introducer, and a reader.FDA approved, through the de novo process, the VeriChip ™ Health Information Microtransponder System, consisting of an implantable chip, an introducer, and a reader. After the chip is implanted subcutaneously, a caregiver is able to retrieve a unique patient identifier and patient medical information from a prescription website when the patient is otherwise unable to provide this information. The medical information on the website is supplied by the patient and can only be accessed with appropriate authorization.

New prosthetic jaw joint

Total Temporomandibular Joint Replacement SystemThe Total Temporomandibular Joint Replacement System by Walter Lorenz Surgical, Inc. is a prosthetic jaw joint. The device is used for patients who need a total jaw replacement due to one or more of the following conditions: severe arthritic conditions, fused joints, previous multiple surgeries, severe fractures, tumors and severely degenerated joints. The device is a ball and socket joint with one side mounted to the jaw and the other side mounted to the head in front of the ear. A surgeon implants the joint after removing any old devices, unsuccessful grafts, and badly damaged bone. It may reduce jaw pain, reduce interference with eating and increase the ability to open the mouth.


Catheter to treat cerebral ischemia

NeuroFlo™ Catheter to treat cerebral ischemia The NeuroFlo™ Catheter by CoAxia, Inc. is used to treat cerebral ischemia, a condition that occurs when the brain does not receive enough blood flow to maintain normal neurologic function such as speech, movement, and understanding. The NeuroFlo™ Catheter is a long, flexible tube with two small balloons on one end that is used to partially block blood flow in large blood vessels. It is used for the treatment of cerebral ischemia resulting from symptomatic vasospasm in patients who have not responded to other forms of treatment. Symptomatic vasospasm is the squeezing down of a blood vessel in the brain that results in symptoms similar to stroke such as difficulty in speaking, movement, or understanding.

Monitoring leaks of vascular graft

CardioMEMS, a device intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair. FDA approved, through the de novo process, the CardioMEMS, a device intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair. The device is intended to be used as an adjunctive tool in the detection of intraoperative endoleaks. It is designed to be implanted in the abdominal aortic aneurysm (AAA) sac during the deployment of a stent-graft. It senses the pressure in the AAA sac so that information regarding possible endoleaks or AAA rupture can be collected.
Oral rinse for gingivitis

Decapinol, a prescription oral rinse used to reduce the adhesion of dental plaque FDA approved, through the de novo process, a prescription oral rinse used to reduce the adhesion of dental plaque. Decapinol was cleared by CDRH as a medical device for the treatment of gingivitis because of its mechanism of action. Decapinol works by preventing attachments of bacteria to tooth surfaces rather than being bactericidal. Gingivitis, the earliest stage of gum disease, is an inflammation of the gums caused by a build up of bacteria that grow in the coating (plaque) that forms on teeth between brushings. The rinse forms a barrier that reduces bacterial attachment to tooth surfaces. The interference with bacterial attachment reduces the formation of plaque associated with gingivitis. The rinse is used in addition to normal oral hygiene such as brushing and flossing. It is intended to be used twice daily for one minute after brushing and flossing.

Surgical Laser for use in Assisted Reproductive procedures

Hamilton Thorne Zona Infrared Laser Optical System for use in Assisted Reproductive proceduresFDA approved, through the de novo process, the Hamilton Thorne Zona Infrared Laser Optical System (ZILOS-th ® ). The device is used to drill a small tangential hole in the zona pellucida of embryos to facilitate embryo hatching prior to implantation. This device has been shown to increase implantation rates in older women (>37 years), and patients utilizing frozen embryos.


Laser Scanning Technology for Confocal Microscopy of the Cornea

Heidelberg Engineering HRT II laser scanning technology, ophthalmic confocal laser scanning microscopeThe Heidelberg Engineering HRT II laser scanning technology combined with the Rostock Cornea Module (RCM) is the first FDA-cleared ophthalmic confocal laser scanning microscope for directly imaging a patient's cornea and anterior segment. The confocal laser scanning microscope is a valuable tool for obtaining high resolution images and 3-D reconstructions of thick specimens at various depths. Images are taken point-by-point and reconstructed with a computer, rather than projected through an eyepiece. This confocal microscope allows for imaging at different depths inside of the cornea, as well as the front of the eye, with high resolution.

Patient -administered analgesia control

Patient Therapy Manager (PTM) accessory to the SynchroMed Implantable Infusion System The Patient Therapy Manager (PTM) accessory to the SynchroMed Implantable Infusion System allows a patient to self-administer a bolus of pain medication from the SynchroMed Implantable Infusion System based upon the parameters programmed by a physician. This is the first device for patient administered analgesia control for an implantable infusion pump.
Application Activity

ODE reviews four major types of marketing applications: Premarket Notification (i.e., a 510(k) submission), Premarket Approval Application (PMA), Product Development Protocol (PDP), and Humanitarian Device Exemption (HDE). Devices cleared for marketing through the 510(k) process are too numerous to list here but can be found at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm .

During Fiscal Year 2005, ODE approved 29 PMAs and 2 HDEs. These are listed below. We recommend turning to the PMA approval website, which is available at http://www.fda.gov/cdrh/consumer/mda , for easy-to-understand one pagers for each PMA approved. The Premarket Approval Application (PMA) approval website describing recently approved devices with patient information is available at http://http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ DeviceApprovalsandClearances/default.htm .

Original PMA/HDE Approvals for Fiscal Year 2005

15–Oct–04 P030011 SynCardia Systems, Inc. Syncardia temporary CardioWest Total Artificial Heart (TAH-t)
22-Oct-04 P040003 InSightec, Ltd. InSightec ExAblate ® 2000
26-Oct-04 P040006 DePuy Spine, Inc. CHARITE ™ Artificial Disc
29-Oct-04 P040002 Endologix, Inc. Endologix PowerLink ® System – Bifurcated Infrarenal Stent Grafts, Limb Extension, and Proximal Cuff
03-Nov-04 P040022 angio LINK Corporation EVS ™ Vascular Closure System
05-Nov-04 P030031 Biosense Webster, Inc. Biosense Webster NaviStar ™ /Celsius ™ ThermoCool ® Diagnostic/Ablation Deflectable Tip Catheters
23-Nov-04 P030007 Eastman Kodak Company Kodak Mammography CAD Engine
03-Dec-04 P010029 Savient Pharmaceuticals, Inc. Nuflexxa™ (1% Sodium Hyaluronate)
06-Dec-04 P040027 W.L. Gore & Associates GORE VIATORR Ò TIPS
16-Dec-04 P030030 Genyx Medical, Inc. URYX® Urethral Bulking Agent
17-Dec-04 P030022 Smith and Nephew, Inc. Reflection® Ceramic Acetabular System
23-Dec-04 P030034 Orthofix, Inc. Cervical-Stem® Model 505L Cervical Fusion System
14-Jan-05 P040014 Irvine Biomedical IBI Therapy™ Cardiac Ablation System
21-Mar-05 P040020 Alcon Research Ltd. The ACRYSOF® ReSTOR® Apodized Diffractive Optic Posterior Chamber Intraocular
23-Mar-05 P040043 W.L. Gore and Associates GORE TAG Thoracic Endoprosthesis
25-Mar-05 P040024 Medicis Aesthetics Holdings, Inc. Restylane™ Injectable Gel
30-Mar-05 H030005 CoAxia, Inc. CoAxia NeuroFlo™ Catheter
01-Apr-05 P040026 Medispec, Ltd. Orthospec™ Extracorporeal Shock Wave Therapy Device
07-Apr-05 P040034 Confluent Surgical, Inc. DuraSeal™ Dural Sealant System
12-Apr-05 P040016 Boston Scientific Corporation Liberte™ Monorail™ and Over-the-Wire Coronary Stent
29-Apr-05 P030037 Biotronic GmbH Rithron-XR Coronary Stent System
03-May-05 P040023 DePuy Orthopedics, Inc. Duraloc® Option Ceramic Hip System
14-Jun-05 P040037 W. L. Gore & Associates, Inc. GORE VIABAHN® Endoprosthesis
21-July-05 P030004 Micro Therapeutics, Inc. Onyx® Liquid Embolic System (LES)
03-Aug-05 P030036 Medtronic, Inc. Medtronic® SelectSecure™ Lead Model 3830
03-Aug-05 H050001 Boston Scientific SMART Wingspan™ Stent System with Gateway™ PTA Balloon Catheter
05-Aug-05 P040021 St. Jude Medical, Inc. SJM Biocor™ and Biocor™ Supra Valves
10-Aug-05 P040039 Orthometrix, Inc. Orbasone Pain Relief System
17-Aug-05 P040044 AccessClosure, Inc. Matrix VSG™ System, Model MX-100
06-Sept-05 P040038 Abbott Vascular Devices Xact® Carotid Stent System
21-Sept-05 P020016 Walter Lorenz Surgical, Inc. Total Temporomandibular Joint Replacement System

Expedited Original and Panel Track Supplement PMA Approvals

22-Oct-04 P040003 InSightec, Ltd. InSightec ExAblate ® 2000
26-Oct-04 P040006 Depuy Spine, Inc. CHARITÉ™ Artificial Disc
06-Dec-04 P040027 W.L. Gore & Associates Gore Viatorr TIPS
23-Mar-05 P040043 W.L. Gore & Associates Gore TAG Thoracic Endoprosthesis
15-Jul-05 P970003/S050 Cyberonics, Inc. VNS Therapy System

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 1-800-638-2041 or 240-276-3103 directly between the hours of 8:00 a.m. – 5:00 p.m. EST
Fax: 240-276-3101