Humanitarian Device Exemption Approval Order: Ovation Abdominal Stent Graft System - H100008
This device is indicated for use as an adjunct to
surgery in the management of pediatric and adult patients with the following clinical conditions:
- Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm
in diameter when originally implanted and
- Dysfunctional Right Ventricular Outflow Tract (RVOT) conduits with a clinical indication
for intervention, and either:
- Regurgitation: > moderate regurgitation, or
- Stenosis: mean RVOT gradient > 35 mmHg.
09M-0090 Reclaim™ Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD) Therapy Medtronic Neuromodulation This device is indicated for bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).H060002
08M-0579 IBV® Valve System Spiration, Inc. This device is indicated to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV® Valve System use is limited to 6 weeks per prolonged air leak. H040004
08M-0562 INFUSE/MASTERGRAFT™ Posterolateral Revision Device Medtronic Sofamor Danek USA, Inc. This device has been withdrawn at the request of the sponsor effective March 23, 2010.H070004
08M-0563 Levitronix Centrimag® Right Ventricular Assist System (RVAS) Levitronix, LLC This device is indicated for temporary circulatory support for up to 14 days for patients in cardiogenic shock due to acute right ventricular failure.H070003
08M-0378 NeuRx RA/4 Synapse Biomedical, Inc. This device is indicated for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.H990002
07M-0415 Epicel® (cultured epidermal autografts) Genzyme Biosurgery The device is indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.H060001
07M-0190 ENTERPRISE Vascular Reconstruction Device and Delivery System Cordis Neurovascular, Inc. Use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of >= 3 mm and <= 4 mm. Wide-neck is defined as having a neck width >= 4mm or a dome-to-neck ratio < 2.H060003
07M-0156 Onyx® Liquid Embolic System (Onyx® HD-500, Model 105-8101-500) EV3 Neurovascular Treatment of intracranial, saccular, sidewall aneurysms that present with a wide neck (>= 4 mm) or with a dome-to-neck ratio < 2 that are not amenable to treatment with surgical clippingH060004
07M-0038 Fujirebio Mesomark™ Assay Fujirebio Diagnostics, Inc. The Fujirebio Diagnostics, Inc. (FDI) MESOMARK™ is an Enzyme Linked Immunosorbent Assay (ELISA) for the quantitative measurement of Soluble Mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epitheloid or biphasic mesothelioma. MESOMARK™ values must be interpreted in conjunction with all other available clinical laboratory data.H040006
06M-0368 Abiocor® Implantable Replacement Heart Abiomed, Inc.
This device is indicated for use in severe biventricular end stage heart disease patients who are not cardiac transplant candidates and who
- are less than 75 years old,
- require multiple inotropic support,
- are not treatable by LVAD destination therapy, and
- are not weanable from biventricular support if on such support.
06M-0163 Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set, Karl Storz Rigid TTTS Fetoscopy Instrument Set with 0 or 12 degree scope, and Karl Storz Rigid TTTS Fetoscopy Instrument Set with 30 degree scope Karl Storz Endoscopy-America, Inc. The Karl Storz TTTS Fetoscopy Instruments Sets are indicated for selective laser photocoagulation (S-PLC) in the treatment of twin-to-twin transfusion syndrome (TTTS) for fetuses whose gestational age is between 16 and 26 weeks.H050001
05M-0308 Wingspan Stent System with Gateway PTA Balloon Catheter Boston Scientific Smart This device is indicated for improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with greater than or equal to 50% stenosis that are accessible to the system.H030005
05M-0132 CoAxia NeuroFlo Catheter CoAxia, Inc. This device is indicated for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management.H030009
04M-0415 Vertical Expandable Prosthetic Titanium Rib (VEPTR) Synthes (USA)
For the treatment of Thoracic Insufficiency Syndrome (TIS) in skeletally immature patients. TIS is defined as the inability of the thorax to support normal respiration or lung growth. For the purpose of identifying potential TIS patients, the categories in which TIS patients fall are as follows:
Flail Chest Syndrome
Rib fusion and scoliosis
Hypoplastic thorax syndrome, including
- Jeune's syndrome
- Jarcho-Levin syndrome
- Ellis van Creveld syndrome
06M-0233 INTACS® Prescription Inserts for Keratoconus (0.25mm, 0.30mm, and 0.35mm) Addition Technology
INTACS® prescription inserts are intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for a corneal transplant procedure may potentially be deferred.
The specific subset of keratoconic patients proposed to be treated with INTACS® prescription inserts are those patients:
- who have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles;
- who are 21 years of age or older;
- who have clear central corneas;
- who have a corneal thickness of 450 microns or greater at the proposed incision site; and
- who have corneal transplantation as the only remaining option to improve their functional vision.
04M-0165 OP-1 Putty Stryker Biotech
35 South Street
Hopkinton, MA 01748 For use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.H030003
04M-0090 DeBakey VAD Child Left Ventricular Assist System MicroMed Technology, Inc. For use to provide temporary left side mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients (5-16 years old, with BSA>= 0.7 m2 and <1.5 m2) who are in NYHA Class IV end stage heart failure, are refractory to medical therapy and who are (listed) candidates for cardiac transplantation.H030004
04M-0084 Heartsbreath Menssana Research Inc.
1 Horizon Road
Fort Lee, NJ 07024-6510
USA For use as an aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. The Heartsbreath test is intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month.H020003
03M-0536 CONTEGRA Pulmonary Valved Conduit Medtronic, Inc The CONTEGRA Pulmonary Valved Conduit is indicated for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) in patients aged less than 18 years with any of the following congenital heart malformations:
- Pulmonary Stenosis
- Tetralogy of Fallot
- Truncus Arteriosus
- Transposition with Ventricular Septal Defect (VSD)
- Pulmonary Atresia
03M-0305 Dermagraft Smith and Nephew Wound Management This device has been withdrawn by the sponsor as of September 28, 2007.H020007
03M-0157 Medtronic Activa Dystonia Therapy Medtronic Neurological For unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients seven years of age or aboveH020002
02M-0409 Neuroform Microdelivery Stent System SMART Therapeutics, Inc.
2551 Merced St.
San Leandro, CA 94577
USA The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than or equal to 2mm and less than or equal to 4.5mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are defined as having a neck of 4mm or a dome-to-neck ratio of <2.H010004
02M-0361 NEUROLINK® System, including NEUROLINK® Stent & Delivery Catheter and NEUROLINK® Balloon Dilatation Catheter Guidant Corporation
Santa Clara, CA USA The NEUROLINK® System is indicated for the treatment of patients with recurrent intracranial stroke attributable to atherosclerotic disease refractory to medical therapy in intracranial vessels ranging from 2.5 to 4.5 mm in diameter with > 50% stenosis and that are accessible to the stent system H000007
02M-0167 Amplatzer® PFO Occluder AGA Medical Corporation
02M-0121 Ascension® PIP Ascension Orthopedics, Inc.
Austin, TX For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patients has soft tissue and bone that can provide adequate stabilization and fixation under high demand loading conditions after reconstruction; and needs a revision of a failed PIP prostheis, or has pain, limited motion, or joint subluxation/dislocation secondary to damage or destruction of the articular cartilage.H000002
02M-0311 VISX Excimer Laser System and Custom Contoured Ablation Pattern (C-CAP) Method™ VISX, Inc. For the treatment of asymmetrical ablation patterns from previous laser refractive surgery caused by decentration of the treatment as viewed on the Zeiss Humphrey® topography unit and treated with the STAR S3 ActiveTrak™ Excimer Laser System in patients:
- who exhibit symptomatology supportive of visual defect: reduced best spectacle-corrected visual acuity, debilitating glare, monocular diplopia (double vision), and/or debilitating halos; and,
- who pre-operatively have at least a 6 µm difference on the elevation topography, from the lowest point to the highest point, over a 6.5 mm diameter or over the patient’s pupil diameter as measured by the Zeiss Humphrey topographer, whichever is larger
01M-0482 OP-1™ Implant Stryker Biotech
Hopkinton, MA The device is indicated for use as an alternative to autograph in recalcitrant long bone nonunions where use of autograph is unfeasible and alternative treatments have failed.H010001
01M-0392 Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis Avanta Orthopaedics, Inc.
San Diego, CA The device is indicated for use in arthroplasty of the MCP joint when either the:
- patient is in need of a revision of failed MCP prosthesis(es); or
- patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic MCP joint.
01M-0485 PROSTALAC Hip Temporary Prosthesis DePuy Orthopaedics, Inc., a Johnson & Johnson Company This device is indicated for use as a short-term total hip replacement (THR) in patients who need a two-stage procedure to treat a confirmed infection of their THR and where vancomycin and tobramycin are the most appropriate antibiotics for treatment of the infection based on the susceptibility pattern of the infecting microorganism(s).H990013
01M-0201 Composite Cultured Skin (CCS) Ortec International, Inc.
New York, NY 10032 For use in patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB) as an adjunct to standard autograft procedures (i.e., skin grafts and flaps) for covering wounds and donor sites created after the surgical release of hand contractures (i.e., “mitten” hand deformities).H000001
010M-006 JOMED JOSTENT® Coronary Stent Graft JOMED AB For Use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts > 2.75 mm in diameter.H990012
00M-1354 TAS Ecarin Clotting Time Test Cardiovascular Diagnostics, Inc. To be used to determine the anticoagulant effect of recombinant hirudin (r-hirudin) during cardiopulmonary bypass in patients who have heparin induced thrombocytopenia (HIT).H990014
00M-1451 Enterra™ Therapy System (formerly named Gastric Electrical Stimulation (GES) System Medtronic, Inc. For the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. H990008
00M-1228 Telescopic Plate Spacer (TPS) Spinal System Interpore Cross International
The sponsor has withdrawn this HDE effective Sept. 1, 2010H990011
99M-5539 TheraSphere® MDS Nordion, Inc.,
Kanata, Ontario, Canada For radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters.H990007
99M-4810 Shelhigh Pulmonic Valve Conduit Model NR-4000 with "No-React®" Treatment Shelhigh, Inc. For replacement of the diseased, damaged. or absent pulmonic artery in small children or infants up to age 4 years, with Transposition of the Great Arteries, Truncus Arteriosis, Tetrology of Fallot with associated cardiac anomalies or with Pulmonary Atresia, or replacement of failed conduits in young patients with accelerated conduit failure.H990005
99M-4763 CardioSEAL®Septal Occlusion System Nitinol Medical Technologies, Inc For the treatment of patients with complex ventricular septal defects (VSD) of a significant size to warrant closure, but that, based on location, cannot be closed with standard surgical transatrial or transarterial approaches.H990003
99M-4619 Acticon™Neosphincter American Medical Systems, Inc. For the treatment of severe fecal incontinence in post-pubescent males and females who have failed, or are not candidates for, less invasive forms of restorative therapy.H990004
99M-4134 CardioSEAL® Septal Occlusion System Nitinol Medical Technologies, Inc. For the treatment of patients with complex single ventricle physiology who have undergone a fenestrated Fontan palliation procedure and require closure of the fenestration.H980008
99M-0255 VOCARE® Bladder System NeuroControl Corporation
Valley View, OH 44125 For the treatment of patients who have clinically complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine. Secondary intended use is to aid in bowel evacuationH980005
99M-0150 VOCARE® Bladder System NeuroControl Corp.
Valley View, OH 44125 For the treatment of patients who have clinically complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine.H980002
98M-0895 Avanta Proximal Interphalangeal (PIP) Finger Prosthesis Avanta Orthopaedics, Inc For use in arthroplasty of the PIP joint when either the: (1) patient is in need of a revision of failed PIP prosthesis(es); or (2) patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumaic arthritic PIP joint.H970005
98M-0452 Perma-Flow® Coronary Graft, Model 2C10 Possis Medical, Inc.
Minneapolis, MN 55433 For single or multiple vessel coronary artery bypass in patients who are receiving coronary bypass grafting but who have inadequate autologous conduit to complete the required revascularization.H970004
98M-0435 Excorim® Immunoadsorption System Cobe BCT., Inc.
Lakewood, CO 80215 For use in the treatment of patients with hemophhilia A and B who have Factor VIII or Factor IX inhibitor titers above 10 Bethesda Units/ml (BU/ml). The purpose of the system is to lower the inhibitor levels so that routine clotting factor rerplacement therapy can be considered. It may be used in an acute setting (to control bleeding during an acute hemmorrhage or for emergency surgery) or as a preventive measure to prepare patients for elective surgery.H970003
98M-0163 Urostim William E. Kaplan, M.D. and Ingrid Richards, R.N., MSN
Chicago, IL 60614 For use in children for the treatment of neurogenic bladder disease secondary to spina bifidaH970001
98M-0164 King's College Hospital (KCH) Fetal Bladder Drainage Catheter Rocket Medical PLC
England For urinary tract decompression following the diagnosis of post-vesicular obstructive uropathy in fetuses 18 to 32 weeks gestational ageH960001
97M-0124 Harrison Fetal Bladder Stent Set (Lowery Modification) Cook OB/GYN®
Spencer, IN 47460 For fetal urinary tract decompression following the diagnosis of fetal post-vesicular obstructive uropathy in fetuses of 18 to 32 weeks gestational age