Are current regulations for approval of in vitro diagnostic devices adequate?
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Device Approval↗
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Carotid stenting with distal protection in high surgical risk patients: the BEACH trial 30 day results.
BACKGROUND: The BEACH trial evaluated the outcomes of carotid artery stent placement with distal emboli protection, using the Carotid Wallstent and the FilterWire EX/EZ(TM), in patients at high surgical risk for carotid endarterectomy (CEA). METHODS: We enrolled 747 patients at high surgical risk for CEA due to prespecified anatomical criteria and/or medical comorbidities. The trial included both symptomatic (>50% carotid artery stenosis) as well as asymptomatic (>80% carotid artery stenosis) high surgical risk patients. Three groups of patients were included in the trial. The Roll-in (R) group (n = 189/747, [25%]) included up to nine patients per site for familiarization of the device and protocol; the Pivotal (P) group (n = 480/747, [65%]) was intended for presentation to the FDA for consideration of device approval; and a Bilateral (B) registry group (n = 78/747, [10%]) was included because of the need to treat patients with bilateral carotid artery disease. In the 480 Pivotal patients, anatomic criteria represented the most frequent high-risk surgical category for enrollment (58.8%), followed by prior CEA (34.2%), multivessel (>or=2) coronary artery disease (21.7%), and contralateral carotid occlusion (18.1%). RESULTS: The technical success rate for stent deployment and FilterWire EX/EZ deployment and retrieval was 98.2%. The mean postprocedure angiographic diameter stenosis in the Pivotal group was reduced to 10.8%, while the overall procedure success rate (<50% residual diameter stenosis) after stent deployment was 98%. The 30 day composite major adverse event (MAE) rate for the entire cohort of 747 patients (i.e. inclusive of all 3 groups) was 5.8% (all death = 1.5%, all stroke = 4.4%, and all myocardial infarction (MI) = 1.0%). In subgroup analysis, there was no significant difference in the MAE rate between the three groups (P = 5.8%, R = 6.9%, B = 2.6%, P = 0.42). CONCLUSION: The similarity in periprocedural event rates for the Pivotal and Roll-in groups suggests a flat learning curve for experienced operators using this carotid stent system. The similarity in event rates for the Bilateral group, when compared with the Roll-in and Pivotal groups, suggests that staged sequential treatment of bilateral stenoses may be performed at the same risk as for unilateral lesions. The 30-day safety of this stent and distal emboli protection system is encouraging and compares favorably with other carotid stent trials in high surgical risk patients.
Aged↗
[Ultrasound mammography and magnetic resonance mammography as adjunctive methods in mammography screening].
Ultrasonography and magnetic resonance (MR) tomography are helpful tools to evaluate unclear lesions found at screening mammography. Ultrasound is particularly useful to prove the presence of a cyst or to further examine unclear, asymmetrical densities. With MR mammography, carcinomas can be found even when x-ray mammography or ultrasonography are limited due to diffuse, benign, proliferative changes. Ultrasound guidance has greatly facilitated core needle biopsy for suspicious lesions. Additionally, approved devices for MR-guided biopsy are commercially available. As a primary screening tool, ultrasound or MR mammography may be used only in women who are positive for BRCA-1 or BRCA-2 mutations or who are otherwise at high risk for breast cancer.
Adult↗
A 64-year old man who sustained many episodes of acute cardiogenic pulmonary edema successfully treated with Boussignac continuous positive airway pressure: a case report.
Continuous positive airway pressure (CPAP) is standard treatment for patients with acute cardiogenic pulmonary edema. We describe a patient who had 21 episodes of acute cardiogenic pulmonary edema due to very poor patient compliance. This 64-year old man had end-stage congestive heart failure based on systolic left ventricular dysfunction following two myocardial infarctions. In addition to routine medical treatment 15 episodes of pulmonary edema were successfully treated with Boussignac continuous positive airway pressure (BCPAP). The BCPAP system is a simple, disposable, FDA-approved device that delivers positive pressure without a ventilator. This extraordinary case underscores the utility of the BCPAP system to avoid repeated intubation and mechanical ventilation in patients with cardiogenic pulmonary edema.
Acute Disease↗
Intravascular ultrasound in the drug-eluting stent era.
Intravascular ultrasound (IVUS) has become an indispensable part of all drug-eluting stent (DES) studies; findings must be put into context with the IVUS findings in bare metal stents. Unfortunately, there is not yet a complete picture of either the Cypher (Cordis, Miami, Florida) or the Taxus (Boston Scientific, Maple Grove, Minnesota) stent (the two U.S. Food and Drug Administration-approved devices). Intimal hyperplasia volume in DES is reduced to <15% of stent volume, but stent underexpansion continues to be a consistent finding in DES failures (restenosis and thrombosis). The utility of IVUS to assure adequate stent expansion may be more important whenever there are clinical risk factors for DES failure.
Cardiology↗
The development of endotension is associated with increased transmission of pressure and serous components in porous expanded polytetrafluoroethylene stent-grafts: characterization using a canine model.
OBJECTIVE: This study used a canine model of abdominal aortic aneurysms (AAAs) to compare intra-aneurysmal pressure and thrombus formation after exclusion with Dacron and expanded polytetrafluoroethylene (ePTFE) stent-grafts. METHODS: Prosthetic AAAs with implanted strain-gauge pressure transducers were treated by stent-graft exclusion using Food and Drug Administration-approved devices in 10 mongrel dogs: five Dacron (AneuRx) and five ePTFE (original Excluder). Intra-aneurysmal pressure was measured over 4 weeks after AAA exclusion and indexed to the systemic pressure, represented as a percentage of a simultaneously obtained systemic pressure (value = 1.0). Magnetic resonance imaging (MRI) of the intra-aneurysmal thrombus was performed at 1, 2, and 4 weeks after exclusion and expressed as a signal-to-noise ratio (S:N) to control for background signal intensity. Comparisons of pressures and S:N between the two stent-grafts was analyzed with the Student's t test. Intra-aneurysmal thrombus was characterized histologically. RESULTS: In animals excluded with both Dacron and ePTFE stent-grafts, the intra-aneurysmal pressure was nonpulsatile and reduced to <30% of systemic pressure. Significantly greater pressure transmission was observed after AAA exclusion using ePTFE compared with Dacron stent grafts (systolic pressure: ePTFE, 0.28 +/- 0.12 vs Dacron, 0.11 +/- 0.02, P < .001; mean pressure: ePTFE, 0.16 +/- 0.08 vs Dacron, 0.06 +/- 0.02, P < .001). MRI confirmed the absence of perfusion in all aneurysms. The T1-weighted signal intensity remained persistently elevated (S:N at 1 week, 2.7 +/- 0.4 vs 2 weeks, 4.0 +/- 0.2 vs 4 weeks, 5.4 +/- 1.3) in ePTFE-treated intra-aneurysmal thrombus, suggesting an absence of thrombus organization. In contrast, progressive evolution of T1 signal intensity in aneurysms excluded by Dacron stent-grafts was consistent with maturation from intact red blood cells (S:N at 1 week, 3.3 +/- 0.4) to methemoglobin (S:N at 2 weeks, 6.1 +/- 0.8), and then hemosiderin and ferritin (S:N at 4 weeks, 2.4 +/- 0.5). Histologically, ePTFE-excluded aneurysms contained poorly organized thrombus with red blood cell fragments and haphazardly arranged fibrin deposition indicative of active remodeling and continued influx of transudated serum. In aneurysms excluded by Dacron stent-grafts, dense, mature collagenous connective tissue and organized fibrin were present, indicative of greater thrombus organization. CONCLUSIONS: Stent-graft treatment reduces intra-aneurysmal pressure to <30% of systemic pressure when no endoleak is present; however, significantly greater pressure is present in aneurysms treated with porous ePTFE stent-grafts than Dacron grafts. Histologic and MRI imaging analysis suggest that active transudation of serous blood components may be contributing to this increased intra-aneurysmal pressure.
Animals↗
Long-term follow-up of Intacs from a single center.
PURPOSE: To evaluate the long-term visual results in patients having Intacs placement for the correction of mild myopia. SETTING: Department of Ophthalmology, Mount Sinai School of Medicine and the Mount Sinai Hospital of Mount Sinai NYU Health, New York, New York, USA. METHODS: Patients with mild myopia (spherical equivalent between -0.75 and -4.50 diopters [D]) were enrolled to have Intacs placement between May 1995 and March 1999 under United States Food and Drug Administration Phase II and Phase III clinical trials for intrastromal corneal ring segments (ICRS). Six insert thicknesses were evaluated: 0.21, 0.25, 0.30, 0.35, 0.40, and 0.45 mm. The long-term results evaluated were uncorrected visual acuity (UCVA), maintenance of best spectacle-corrected visual acuity (BSCVA), predictability and stability of the refractive effect, induced manifest refraction cylinder, slitlamp findings, self-reported visual symptoms, and maintenance of mesopic contrast sensitivity. RESULTS: One hundred fourteen eyes of 73 patients were enrolled; 113 eyes of 72 patients received Intacs. There were no serious intraoperative or postoperative complications. The mean follow-up was 17.5 months +/- 8.9 (SD). At the end of this period (number of eyes evaluated = 100), the UCVA was 20/40 or better in 95 eyes (95.0%), 20/20 or better in 72 (72%), and 20/16 or better in 41 (41%). None of the 113 eyes lost 10 or more letters or 2 or more lines of preoperative BSCVA. The mean change in the cycloplegic refraction spherical equivalent for the 6 insert thicknesses was as follows: -0.75 +/- 0.00 D for 0.21 mm; -1.17 +/- 0.42 D for 0.25 mm; -2.00 +/- 0.54 D for 0.30 mm; -2.59 +/- 0.53 D for 0.35 mm; -3.09 +/- 0.54 D for 0.40 mm; and -3.82+/-0.80 D for 0.45 mm. The refractive correction was within +/-1.0 D of the predicted outcome in 103 eyes (92.0%) and within +/-0.5 D in 72 eyes (63.7%). Intacs were removed from 6 eyes (5.3%). All 4 eyes for which data were available 3 months after removal returned to within +/-0.5 D of their preoperative manifest refraction spherical equivalent. Intacs were exchanged because of undercorrection in 2 eyes (1.8%). These eyes gained 3 and 5 lines of UCVA 12 months and 18 months, respectively, after the exchange procedure. Overall, 85.7% (36/42) of the patients were satisfied with the results of the Intacs procedure. CONCLUSION: Intacs safely and effectively corrected mild myopia. Placement is a brief, easy outpatient procedure. The refractive effect was predictable and stable over long-term follow-up. Results from a limited number of removal and exchange procedures indicate that Intacs are removable and adjustable.
Adult↗
A novel 'sort-suicide' fusion gene vector for T cell manipulation.
Retroviral suicide gene vectors have successfully been used in clinical studies to improve the safety of adoptive immunotherapy with allogeneic T lymphocytes in the treatment of malignant and viral diseases. At the same time these studies have revealed several problems that are yet to be resolved including impaired T cell function due to long ex vivo culture. Here we present new retroviral vectors co-expressing truncated CD34, a gene transfer marker which ensures rapid enrichment of transduced cells using commercially available GMP-approved devices, and a splice-corrected variant of Herpes simplex virus thymidine kinase (scHSVtk) which confers high sensitivity to the prodrug ganciclovir. We show that a retroviral hybrid vector, MP71, based on the myeloproliferative sarcoma virus (MPSV) and the murine embryonic stem cell virus (MESV), encoding a tCD34/scHSVtk fusion protein mediates high expression of the 'sort-suicide' selection marker, thereby allowing for highly efficient purification and selective elimination of transduced cells.
Antigens, CD34↗
Comparison of the Q-switched alexandrite, Nd:YAG, and ruby lasers in treating blue-black tattoos.
BACKGROUND: A new generation of highly selective short-pulsed lasers has emerged in recent years for the treatment of tattoos. Several studies (including reports by the present investigators) have proven the efficacy of each of the three commercially available, FDA approved devices; namely, the Q-switched alexandrite, Q-switched Nd:YAG and Q-switched ruby lasers. Considerable differences among the three have been reported in relation to the rate of clearing of the tattoo ink particles, tissue effects, beam profile, wound healing, and side effects. OBJECTIVE: This study was primarily conducted to examine and compare the clinical response of patients with blue-black tattoos simultaneously treated with three different Q-switched lasers (alexandrite, Nd:YAG, ruby) with a focus on the percentage of tattoo lightening/clearance and the occurrence or non-occurrence of pigmentary change as a side effect. METHODS: A total of forty-two blue-black tattoos seen at two laser centers (Massachusetts General Hospital Dermatology Laser Center and Laser and Skin Surgery Center of La Jolla) were simultaneously treated with three types of Q-switched lasers: a Candela Q-switched alexandrite laser (755nm 50-100 nanoseconds, 3.0 mm spot size, 6-8 J/cm2); a Continuum Biomedical Q-switched Nd:YAG laser (1064nm, 10-20 nanoseconds, 3.0 mm spot size, 5-10 J/cm2); and a Spectrum Q-switched ruby laser (694 nm, 25-40 nanoseconds, 5.0 mm spot size, 4-10 J/cm2). Paired t-tests and McNemar tests were used to compare the treatment outcome and pigmentation side effects between sites per tattoo, with each site representative of one of the three lasers. The statistical significance level was set at p < .05. RESULTS: Overall, the Q-switched ruby laser had a significant difference in tattoo lightening versus the Q-switched Nd:YAG and Q-switched alexandrite lasers. An increase in the number of treatments paralleled a statistically significant increase in tattoo clearance for all three Q-switched lasers. CONCLUSION: The Q-switched ruby laser had the highest clearance rate in blue-black tattoos and the highest incidence of long-lasting hypopigmentation. The Nd:YAG had no incidence of hypopigmentation.
Adolescent↗
Tracheal gas insufflation.
Tracheal gas insufflation (TGI) is an adjunct to mechanical ventilation that reduces CO (2) present in the anatomic deadspace. This is accomplished by flowing fresh gas (typically 6-10 lpm) directly into the trachea via a catheter placed into the endotracheal tube positioned at the distal end or by an embedded catheter in the wall of a specially designed endotracheal tube. This is thought to improve gas mixing because of the turbulent flow created at the tip of the catheter. There are two methods of gas flow delivery and cycling. Gas flow may be delivered directly toward the carina or in a reverse flow fashion. Cycling of TGI flow may be just during exhalation or during both inhalation and exhalation. A system integrated into the monitoring and controls of a mechanical ventilator could eventually prove the safest and most effective. However, currently there are no FDA-approved devices for TGI administration. It is critical to monitor the adverse effects (triggering, auto-PEEP [positive end expiratory pressure], air trapping, and patient comfort) created by the additional flow introduced into the ventilator circuit, while balancing the CO (2) clearance. There are limited data, mostly from animal studies. However, the trials done in both animal and humans are promising with regard to effective CO (2) elimination and avoidance of unacceptably high peak airway pressures. Available equipment has limited studies with infants. Even within the adult population, much work needs to be done to determine the optimal catheter position, the most appropriate TGI flow characteristics, and improve the safety of TGI.
Journal Article↗
The Kensey catheter: preliminary results with a transluminal atherectomy tool.
The Kensey dynamic angioplasty instrument is an atherectomy device approved by the Food and Drug Administration that uses a rotating cam tip housed within a flexible polyurethane catheter to recanalize obstructed and stenotic arteries. Twenty patients with significant femoral arteriosclerotic occlusive disease underwent attempted transluminal endarterectomy of 23 extremities with the Kensey catheter. Significant improvements of superficial femoral artery luminal diameter was achieved in 10 of 13 patients with stenosis and passage of the spinning catheter tip at 60,000 to 90,000 rpm through areas of complete occlusion was successful in 4 of 10 cases. Balloon dilatation was used as an adjunct to increase the diameter of the superficial femoral artery lumen in 11 of 14 successful cases. This preliminary report provides technical data and short-term follow-up of this new innovative vascular tool.
Angioplasty, Balloon↗
The future of peripheral nerve neurostimulation.
Electrical stimulation of selected peripheral nerves for treatment of intractable pain has been used inconsistently over the past 30 years due to difficulties in clarifying appropriate indications, utilizing approved device technology, and standardizing the surgical techniques. Circumferential electrodes treating mononeuropathies have given way to paddle electrode techniques and, most recently, the application of percutaneous wire electrode methods will allow for minimally invasive peripheral nerve stimulation for certain intractable CRPS and other painful monoeuropathies.
Electric Stimulation Therapy↗
Pediatric cranial fixation: a survey of pediatric neurosurgeons.
To date, there are no broad-based studies defining the standard of care for pediatric neurosurgeons in the area of cranial fixation. Thus, the techniques for cranial fixation remain largely surgeon dependent. Over the past few years, there have been several new cranial fixation devices approved for use in the United States. To gain insights into techniques currently in use by pediatric neurosurgeons, we polled all pediatric neurosurgeons listed in either the American Society of Pediatric Neurosurgeons or the International Society of Pediatric Neurosurgeons regarding their techniques for cranial fixation in a variety of age groups. These survey findings may provide a basis for establishing recommendations and lead to a standard of care for cranial fixation techniques among pediatric neurosurgeons.
Absorbable Implants↗
The conduct of clinical trials: a Food and Drug Agency perspective.
The conduct of a clinical trial required by FDA regulations should be executed in conformity with a protocol developed as a cooperative endeavor involving the Agency, the sponsor requiring device approval for marketing, and the investigators. This is the process most likely to assure a scientifically satisfactory study design that will address the primary concerns of all the parties. More importantly, timely access to safe and effective technologic advances will be made available to the health provider community based on the best scientific evidence.
Clinical Trials as Topic↗
Choice of ear for cochlear implantation: the effect of history and residual hearing on predicted postoperative performance.
OBJECTIVE: This study used mathematical formulas predicting cochlear implant outcomes to investigate the effects of implantation in the poorer ear on postoperative speech recognition. DESIGN: Retrospective cohort study with mathematical and statistical analyses. This study used the University of Iowa formula for predicting outcomes derived from implantation of the better ear on the basis of duration of deafness and preoperative speech understanding, applying this predictive model to a cohort of patients undergoing implantation in the poorer ear at The Johns Hopkins Medical Center. SETTING: Tertiary referral center with active cochlear implant program. PATIENTS: Postlingually deafened adults (n = 58) with preoperative Central Institute for the Deaf sentence scores less than or equal to 40%. INTERVENTION: Cochlear implantation with all three Food and Drug Administration-approved devices. MAIN OUTCOME MEASURE: Postoperative monosyllabic word recognition scores and correlations between actual and predicted results. RESULTS: There was good statistical correlation between the predicted postoperative performance using the University of Iowa formula and the actual performance of our cohort of patients undergoing implantation in the poorer ear (r = 0.50, p < 0.0001). In addition, as a population, our cohort had a mean postoperative consonant-nucleus-consonant word score of 41.8%, which was statistically the same as that predicted by the University of Iowa formula (43.6%). CONCLUSIONS: The postoperative performance of cochlear implant patients is most closely correlated with duration of deafness. However, our results indicate that this measure may not be ear specific and is more reflective of the total auditory receptivity of the patient. These observations help to form guidelines for choice of ear for implantation.
Adolescent↗
Dynamic contour tonometry: a new way to assess intraocular pressure in ectatic corneas.
PURPOSE: To compare intraocular pressure (IOP) measurements in patients with keratoconus (KC), pellucid marginal degeneration (PMD), and unilateral penetrating keratoplasty (PK) for KC by Goldmann applanation tonometry (GAT), Tono-Pen tonometry (TP), and Pascal dynamic contour tonometry (DCT). METHODS: Patients with KC, PMD, or PK were included in a prospective study. IOPs were measured by GAT, TP, and DCT. Severity of ectasia was determined by the steep curvature by corneal topography and central thinning by contact ultrasound pachymetry. IOP measurements were compared and correlated with disease severity. RESULTS: Fifty-three eyes of 36 patients were enrolled. Mean age was 45.3 +/- 12.5 years (range: 28-72 years). Twenty-nine eyes had KC, 21 eyes had a PK for KC, and 3 eyes had PMD. Mean DCT, GAT, and TP readings were 16.1 +/- 2.9, 14.3 +/- 4.1, and 13.8 +/- 4.1 mm Hg, respectively. The differences of mean IOP between GAT and DCT and TP and DCT were statistically significant, whereas the difference between GAT and TP was not. Both GAT and TP readings were significantly higher in the PK eyes than the KC and PMD eyes, whereas DCT readings were not. DCT measurements were not significantly different in PK versus non-PK eyes. CONCLUSION: DCT is a newly Food and Drug Administration (FDA)-approved device that is designed to measure IOP, independent of corneal thickness, corneal curvature, and ocular rigidity. DCT gave significantly higher IOP readings than GAT and TP in this study. DCT readings were not affected by corneal thickness. DCT may be more accurate in IOP measurement in eyes with KC and PMD.
Adult↗
Long-term results of MISTI gold breast implants: a retrospective study.
MISTI Gold breast implants (Bioplasty, St. Paul, Minn.) filled with polyvinylpyrrolidone-hydrogel were developed as a promising alternative to silicone-filled implants. Some studies have reported on the positive effects of the implant, such as improved radiolucency and biocompatibility of the gel; however, there are also reports that such implants increased in volume and were subject to capsular contracture in the human body, resulting in demands for their removal. The purpose of this retrospective study was to analyze the long-term results of a series of patients with MISTI Gold breast implants. Between 1991 and 1993, the authors inserted 83 MISTI Gold implants in 61 patients with an average age of 46 years (range, 16 to 69). The authors were able to follow up 48 patients with 71 MISTI Gold implants. The average follow-up was 68 months (range, 10 to 108 months). The retrospective study found that 59 percent of all MISTI Gold implants were removed after an average period of 4.14 years. The main reason for implant removal was an increase in volume of 38 percent, followed by capsular contracture in 14 percent of all 71 MISTI Gold implants. The average increase in volume of all removed MISTI Gold implants was 43 percent. Capsular contracture was graded as Baker I and II in 63 percent and as Baker III and IV in 37 percent. In conclusion, the authors believe that MISTI Gold implants do not fulfill the criteria of safe breast implants, and they agree with the December of 2000 opinion of the Medical Devices Agency of the Department of Health in London that the hydrogel-filled breast implants should not be used until more information about the filler material and its metabolic fate is available.
Adolescent↗
Patch testing with a standard allergen ("screening") tray: rewards and risks.
The TRUE Test panels, which are the only patch testing devices approved by the Food and Drug Administration in the US, consist of 24 patches, one of which is a negative control. The remaining 23 patches contain 42 unique allergens and four complex mixtures. Although these panels contain approximately 1.4% of the > 3700 known allergens, they perform robustly in detecting allergic contact dermatitis (ACD). Twenty-eight percent of patients are fully evaluated by application of TRUE Test((R)). The present paper reviews the appropriate use of the TRUE Test panels. The need to determine relevance of any positive reaction is stressed. The common causes of false-positive and false-negative reactions are outlined. Those product types where the TRUE Test panels detect the majority of relevant allergic reactions are reviewed, as are the other sources of exposure to the allergens on these panels. The impact of ACD on quality of life is significant. Only by patch testing can the diagnosis be made.
Allergens↗