| Sedasys Computer-assisted Personalized Sedation System (2013) |
Computer-assisted personalized sedation system that administers propofol for minimal-to-moderate sedation; monitors and alarms for physiological vital signs of sedation and limits the depth of sedation. |
232 |
1865 |
2250 |
N/A—no follow-up |
1000 |
Yes |
SSED |
| Dune Medical Devices Marginprobe System (2012) |
Radiofrequency spectroscopy probe system that measures the properties of breast lumpectomy tissue and characterizes it as cancerous or normal. |
546 |
633 |
1578 |
60 |
664 |
Yes |
SSED; clinicaltrials.gov |
| Edwards Sapien Transcatheter Heart Valve (2012) |
Transcatheter heart valve for patients at high risk of mortality from surgical aortic valve replacement; expanded indication for transapical delivery, among other changes. |
934 |
536 |
1328 |
360 |
1057 |
N/A—available for a different indication |
SSED; advisory committee documents |
| Exablate (2012) |
Magnetic resonance ultrasound surgery device used to non-invasively target and ablate tissues; indicated for patients suffering from bone pain due to metastatic disease and for whom standard radiation therapy fails or is not an option. |
1645 |
318 |
1692 |
90 |
139 |
N/A—available for a different indication |
SSED; clinicaltrials.gov |
| Subcutaneous Implantable Defibrillator System (2012) |
Subcutaneous electrode to sense and detect ventricular arrhythmias and deliver defibrillation shocks. |
748 |
280 |
975 |
180 |
330 |
Yes |
SSED |
| Zenith Fenestrated AAA Endovascular Graft (2012) |
Endovascular stent graft used instead of open surgery in patients with abdominal aortic or aorto-iliac aneurysms. |
2342 |
180 |
2650 |
180 |
42 |
N/A—supplement |
SSED |
| Atricure Synergy Ablation System (2011) |
Heart tissue ablation system indicated for patients with persistent or longstanding atrial fibrillation who are undergoing open concomitant coronary artery bypass grafting and/or valve replacement or repair. |
1013 |
356 |
1405 |
180 |
55 |
N/A—available for a different indication |
SSED |
| Edwards Sapien Transcatheter Valve (2011) |
Heart valve delivered via a transcatheter approach meant as an alternative for patients deemed inoperable for open aortic valve replacement. |
1492 |
366 |
1636 |
360 |
358 |
Yes |
SSED |
| Melafind (2011) |
Optical imaging and analysis device to detect melanoma among atypical skin lesions. |
523 |
875 |
1735 |
N/A—diagnostic |
1831 |
Yes |
SSED |
| Vysis ALK Break Apart Fish Probe Kit (2011) |
Laboratory test that detects the presence of chromosomal rearrangements of the ALK gene in non-small cell lung cancer tissue samples to aid in identifying patients eligible for treatment with the cancer drug crizotinib. |
440 |
147 |
602 |
N/A—diagnostic |
136 |
No |
SSED |
| Novocure LTD’s Novo TTF-110A Treatment Kit (2011) |
Portable device that generates alternating electrical fields to treat patients with histologically confirmed glioblastoma multiforme; intended as an alternative to standard medical therapy when surgical and radiation options have been exhausted. |
1470 |
235 |
1753 |
180 |
237 |
Yes |
SSED |
| Pipeline Embolization Device (2011) |
Permanent implant combined with a guidewire-based delivery system placed within the internal carotid artery; intended for adults with wide-necked intracranial aneurysms as an alternative to embolic coils or a liquids. |
718 |
323 |
884 |
180 |
111 |
Yes |
SSED |
| Boston Scientific Cardiac Resynchronization Therapy Defibrillators (2010) |
A ventricular antitachycardia pacing and defibrillation system indicated for patients with mild heart failure. |
1835 |
279 |
2094 |
1020 |
1820 |
N/A—supplement |
SSED |
| Implantable Miniature Telescope (2010) |
Implanted intraocular telescope systems to improve vision in patients at least 75 years old with stable, severe, or profound vision impairment caused by end-stage age-related macular degeneration. |
Not included because we lacked an accurate trial end date. |
Not include in sample since FDA issued a not approv-able letter. |
Not included in sample because we lacked an accurate trial end date and date for the commen-cement of FDA review after the not approv-able letter. |
360 |
217 |
Yes |
SSED; FDA advisory committee documents |
| Alair Bronchial Thermoplasty System (2010) |
Single-use disposable device designed to provide controlled delivery of radiofrequency energy directly to the lungs; indicated for treatment of severe persistent asthma in adults whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists. |
1035 |
483 |
1669 |
360 |
297 |
No |
SSED; clinicaltrials.gov |
| Esteem Totally Implantable Hearing System (2010) |
First totally implantable hearing system to treat moderate to severe hearing loss in adults caused by defective inner ear function; provides an alternative to non-implantable and partially implantable hearing aid technology. |
556 |
225 |
785 |
300 |
60 |
Yes |
SSED |
| Conserve Plus Total Resurfacing Hip System (2009) |
Total hip system with resurfacing femoral component and a metal-on-metal articulation; intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in patients with degenerative joint diseases. |
2274 |
2226 |
3353 |
720 |
1366 |
Yes |
SSED |
| Scandinavian Total Ankle Replacement System (2009) |
An artificial ankle joint replacement, indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis. |
2540 |
1267 |
3176 |
720 |
224 |
Yes |
SSED |
| Navistar & Celsius Thermocool Catheters (2009) |
An ablation catheter threaded through the femoral vein to ablate abnormal heart tissue that causes atrial flutter despite drug therapy. |
1095 |
177 |
1589 |
360 |
167 |
N/A—supplement |
SSED; clinicaltrials.gov |
| Freestyle Navigator Continuous Glucose Monitor (2008) |
Glucose sensor that reports glucose values continuously for up to 120 hours; detects trends and patterns in glucose levels in adults with diabetes. |
99 |
1008 |
917 |
40 |
137 |
No |
SSED |
| Prestige Cervical Disc System (2007) |
Two-piece metal device attached to neck bones with bone screws to replace a diseased cervical discs from C3–C7 following removal of the disc for conditions resulting from a diseased or bulging disc. |
1369 |
423 |
1749 |
720 |
541 |
Yes |
SSED |
| Cormet Hip Resurfacing System (2007) |
Metal-on-metal hip resurfacing system meant for reduction or relief of pain and/or improved hip function in patients with increased activity level who may not be suitable for traditional total hip arthroplasty. |
1896 |
825 |
2238 |
720 |
1154 |
Yes |
SSED; FDA advisory committee documents |
| Guardian Real-Time and Paradigm Real-Time System (Pediatric) (2007) |
Glucose sensors that report glucose values every 5 minutes for up to 72 hours; detects trends and patterns in glucose levels in adolescents with diabetes. |
Not including in sample because we lacked trial start and end dates. |
374 |
Not included in sample because we lacked a trial start date. |
6 |
61 |
N/A—supplement |
SSED |
| Olympic Cool-Cap (2006) |
Fitted cap that provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury in full-term infants with clinical evidence of moderate to severe brain injury due to lack of oxygen. |
1523 |
936 |
2729 |
540 |
235 |
No |
SSED; clinicaltrials.gov; FDA advisory committee documents |
| Cordis Precise Nitinol Stent System (2006) |
Stent and delivery catheter system for high-risk patients with a neurological symptoms and stenosis of the common or internal carotid artery. |
1826 |
1080 |
2243 |
360 |
747 |
Yes |
SSED |
| Birmingham Hip Resurfacing System (2006) |
Metal-on-metal resurfacing artificial hip replacement system to relieve hip pain and improve function by replacing parts of the hip that were damaged by degenerative joint diseases; intended for active patients who may not be suitable for traditional total hip replacement. |
2496 |
659 |
3234 |
Not available |
2385 |
Yes |
SSED |
| Luma Cervical Imaging System (2006) |
Optical detection system to help identify areas on the cervix with precancerous cells which may need to be biopsied; intended for use on women who recently had an abnormal Pap smear and are undergoing evaluation of the cervix. |
420 |
636 |
1302 |
N/A—diagnostic |
2526 |
No |
SSED |
