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PubMed2006

Ventilatory management of sleep-disordered breathing in children.

PURPOSE OF REVIEW: The purpose of this review is to summarize the current management of continuous positive airway pressure and noninvasive positive pressure ventilation in children with sleep-disordered breathing. RECENT FINDINGS: Although most children with sleep-disordered breathing respond to surgical treatment, the use of continuous positive airway pressure and noninvasive positive pressure ventilation in nonresponders has become common, with hundreds of cases reported in the literature, despite the fact that these devices are not approved by the Food and Drug Administration for use in children weighing under 30 kg. Studies show that continuous positive airway pressure and non-invasive positive pressure ventilation are safe and efficacious. Side-effects are minor, and include nasal symptoms and skin breakdown. Midfacial hypoplasia is an uncommon adverse event. Problems with triggering and cycling of noninvasive positive pressure ventilation remain an issue in small or weak children. As in adults, poor adherence is the major obstacle to successful continuous positive airway pressure or noninvasive positive pressure ventilation use. SUMMARY: Continuous positive airway pressure is a useful second-line treatment for children with sleep-disordered breathing. Strategies to improve adherence are needed. Equipment manufacturers should be encouraged to develop equipment that better meets children's needs.

Child↗
PubMed2005

Amotosalen photochemical inactivation of severe acute respiratory syndrome coronavirus in human platelet concentrates.

A novel human coronavirus causing severe acute respiratory syndrome (SARS) emerged in epidemic form in early 2003 in China and spread worldwide in a few months. Every newly emerging human pathogen is of concern for the safety of the blood supply during and after an epidemic crisis. For this purpose, we have evaluated the inactivation of SARS-coronavirus (CoV) in platelet concentrates using an approved pathogen inactivation device, the INTERCEPT Blood System. Apheresis platelet concentrates (APCs) were inoculated with approximately 10(6) pfu mL(-1) of either Urbani or HSR1 isolates of SARS-CoV. The inoculated units were mixed with 150 microm amotosalen and illuminated with 3 J cm(-2) UV-A light. The viral titres were determined by plaque formation in Vero E6 cells. Mixing SARS-CoV with APC in the absence of any treatment decreased viral infectivity by approximately 0.5-1 log10. Following photochemical treatment, SARS-CoV was consistently inactivated to the limit of detection in seven independent APC units. No infectious virus was detected after treatment when up to one-third of the APC unit was assayed, demonstrating a mean log10-reduction of >6.2. Potent inactivation of SARS-CoV therefore extends the capability of the INTERCEPT Blood System in inactivating a broad spectrum of human pathogens including recently emerging respiratory viruses.

Blood Platelets↗
PubMed1998

Initial clinical evaluation of the NovaScan carbon dioxide laser handpiece.

BACKGROUND: This report summarizes an institutional review board-approved 6-month study with the NovaPulse carbon dioxide (CO2) laser utilizing the NovaScan handpiece in facial skin resurfacing applications. OBJECTIVE: This study comprised the initial clinical evaluation (pre-FDA approval) of this device. METHODS: A total of 54 patients underwent 56 laser procedures: 36 full face and 20 regional procedures. RESULTS: Following healing, there was a 91% satisfaction rate. The mean laser-on times were: full face, 27 min; perioral, 7 min; periorbital, 3 min; glabellar, 2.5 min; scar, 5 min; and epidermal lesions, 6 min. CONCLUSIONS: The NovaScan CO2 laser handpiece is a safe tool for skin resurfacing. In its initial use over a 6-month period there were no device-related complications.

Dermatologic Surgical Procedures↗
PubMedDate not supplied

Soft tissue augmentation 2006: filler fantasy.

As an increasing number of patients seek esthetic improvement through minimally invasive procedures, interest in soft tissue augmentation and filling agents is at an all-time high. One reason for this interest is the availability of botulinum toxin type A, which works superbly in the upper face. The rejuvenation of the upper face has created much interest in injectable filling agents and implant techniques that work equally well in the restoration of the lower face. One of the central tenets of soft tissue augmentation is the concept of the three-dimensional face. The youthful face has a soft, full appearance, as opposed to the flat, pulled, two-dimensional look often achieved by more traditional surgical approaches. Injectable filling agents can augment and even at times, replace pulling. Additionally, with the lip as the focal center of the lower face, subtle lip enhancement is here to stay, and is in fact, the number one indication for injectable fillers. Moreover, minimally invasive soft tissue augmentation offers cosmetic enhancement without the cost and recovery time associated with more invasive procedures. As more and more physicians take interest in minimally invasive surgery, courses in cosmetic surgery techniques are becoming increasingly popular at the medical meetings of many specialties. Today, physicians have a much larger armamentarium of techniques and materials with which to improve facial contours, ameliorate wrinkles, and provide esthetic rejuvenation to the face. For a substance or device to be amenable for soft tissue augmentation in the medical community, it must meet certain criteria. It must have both a high "use" potential, producing cosmetically pleasing results with a minimum undesirable reactions, and have a low abuse potential in that widespread or incorrect or indiscriminate use would not result in significant morbidity. It must be nonteratogenic, noncarcinogenic, and nonmigratory. In addition, the agent must provide predictable, persistent correction through reproducible implantation techniques. Finally, the substance, agent or device must be approved by the U.S. Food and Drug Administration, which assures purity, safety, and accessibility, as well as much-needed information regarding use. Having a thorough understanding of the filling agents available, their indications and contraindications, as well as having thorough knowledge of implant technique are vital in providing the patient with an esthetically pleasing result.

Biocompatible Materials↗
PubMed1990

Percutaneous inferior vena caval filters.

Percutaneous placement of caval filters is performed with increasing frequency as an alternative or adjunctive therapy for venous thromboembolic disease. The stainless steel Greenfield filter may be placed surgically or percutaneously. There are now several other approved or investigational devices primarily intended for percutaneous delivery. Morbidity and mortality rates for percutaneous filter placement are lower than those published for surgical filter placement. Choosing among the various devices on the basis of published studies is difficult, as the indications for filter placement; objectivity of follow-up; and criteria for complications, success, and failure vary greatly among studies. The author analyzes published and unpublished data about the physical characteristics; clinical availability; and morbidity, mortality, and efficacy rates of several caval filters. The author concludes that filters should be placed percutaneously rather than surgically, that the ideal device cannot be determined on the basis of current data (and might not exist), and that the choice among devices might depend on clinical circumstances and device characteristics. A strong recommendation is made for an independent, multicenter, prospective, randomized trial and, in the interim, a mandatory registry of all patients receiving caval filters.

Filtration↗
PubMed1993

Transcatheter occlusion of patent ductus arteriosus with adjustable buttoned device. Initial clinical experience.

BACKGROUND: Several devices are available for transcatheter occlusion of patent ductus arteriosus. Most of these devices either require complicated intracardiac maneuvering, have not been tried in humans, or need a large-sized sheath for implantation of the device. METHODS AND RESULTS: During a 26-month period ending November 1992, 14 patients underwent transcatheter closure of patent ductus arteriosus with an adjustable buttoned device delivered via a 7F sheath under an institutional review board-approved custom-made device protocol. The children were 15 months to 8 years of age with weight range of 7.2 to 19 kg. The patent ductus arteriosus measured from 2 to 7.5 mm (median, 3 mm) at the narrowest diameter and was conical, short, or tubular. They were occluded with devices measuring 15 to 20 mm. The ratio of pulmonary to systemic flow decreased (P < .01) from 1.9 +/- 0.6 (mean +/- SD; range, 1.3 to 3.2) to 1.05 +/- 0.1 (1 to 1.3). Continuous murmur of patent ductus arteriosus disappeared in all except 1 patient. Small residual shunts were detected by color Doppler studies in 4 of 14 patients (29%). All patients were followed for 1 to 24 months (mean, 6 +/- 7 months). The device was intact in all patients, and no breakage of the wires was noted. No shunts were seen in 12 of 14 patients (86%), and minute residual shunts were seen in 2 children. No major complications were encountered. CONCLUSIONS: It is concluded that transcatheter closure of patent ductus arteriosus with the adjustable buttoned device is feasible and effective and can be accomplished via small 7F sheaths; a 7F sheath is adequate for all ductal sizes; and the adjustable length of the loop accommodated all types of patent ductus arteriosus. Clinical trials on a larger number of patients are warranted.

Cardiac Catheterization↗
PubMed2004

The increasing threat of personal watercraft injuries.

A trend of increasing number and severity of injuries associated with use of personal watercraft (PWC) has been noted as the use and popularity of PWC also rises. The rate of injuries secondary to PWC use is greater than that from other water sports. Multiple etiologies of injury have been reported, including closed head trauma, spinal injuries, facial fractures, chest trauma, abdominal injuries, and drowning. These injuries may occur from collision with other objects, falls from the PWC, and encounters with the hydrostatic jet stream. The most significant contributing factors to injury seem to be carelessness and inattention. However, some studies show that substance abuse may also contribute. Recommendations to reduce morbidity and mortality include using U.S. Coast Guard-approved personal flotation devices (PFD), limiting use of PWC to trained adults, and improving recognition of significant PWC injury by medical personnel.

Accidental Falls↗
PubMed1997

Noninvasive blood glucose monitoring.

The concentration of glucose in the blood may soon be measured noninvasively, without puncturing the finger to obtain a drop of blood. Current prototype devices for this purpose require greater accuracy and miniaturization to be commercially viable. No such device has been approved for marketing by the U.S. Food and Drug Administration. The technology used for noninvasive blood glucose monitoring involves either radiation or fluid extraction. With radiation technology, an energy beam is 1) applied to the body, 2) modified proportionate to the concentration of glucose in the blood, and 3) measured. The blood glucose concentration is then calculated. With fluid extraction technology, a body fluid containing glucose in a concentration proportionate to the blood glucose concentration is extracted and measured. The blood glucose concentration is then calculated. The most promising technologies are 1) near-infrared light spectroscopy, 2) far-infrared radiation spectroscopy, 3) radio wave impedance, 4) optical rotation of polarized light, 5) fluid extraction from skin, and 6) interstitial fluid harvesting. Each method has features predictive of commercial viability, as well as technical problems to overcome.

Blood Glucose↗
PubMed2004

Long-term outcome after implantation of the Prestige I disc in an end-stage indication: 4-year results from a pilot study.

OBJECT: The long-term function of an artificial cervical disc device is critical to its clinical success. The Prestige I Cervical Disc System has been used clinically since June 1998, and long-term results can now begin to be assessed. The authors conducted clinical and radiographic examinations at 3 and 4 years postoperatively to evaluate the longterm performance of the Prestige I device. METHODS: A pilot trial was initiated in which the Prestige I disc was implanted in a cohort of patients with end-stage disease, who often had a history of multiple previous fusion procedures. All patients were followed according to a standardized clinical and radiographic protocol until 2 years postoperatively. Outcome measures included the Short Form-36 (SF-36) and Neck Disability Index (NDI) questionnaires, neurological status, and radiographic status. To evaluate the long-term function of the device, Ethics Committee approval was obtained to assess the patients at 3 and 4 years postoperatively. All patients were contacted, and after signing an additional informed consent document, were reevaluated according to the standardized protocol. Of the 17 patients in the original cohort, 13 were evaluated at 3 years and 14 were evaluated at 4 years postoperatively. Clinical outcome measures including the NDI and SF-36 showed good improvement, especially when the endstage nature of the disease is considered. Radiographic analysis showed that the Prestige I disc maintained motion at the treated segment at 3 and 4 years postoperatively. CONCLUSIONS: In this report the authors demonstrate the clinical viability of the Prestige I cervical disc system at long-term postoperative intervals, even in the more severe biomechanical environment of end-stage disease.

Adult↗
PubMed1997

Medicare and Medicaid programs; quarterly listing of program issuances--third quarter 1996--HCFA. Notice.

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during July, August, and September of 1996 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this time frame.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed1997

Medicare and Medicaid programs; quarterly listing of program issuances--second quarter 1997--HCFA. Notice.

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during April, May, and June of 1997 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this time frame.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed1997

Medicare and Medicaid programs; quarterly listing of program issuances--first quarter 1997--HCFA. Notice.

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during January, February, and March of 1997 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this time frame.

Aged↗
PubMed1998

Medicare and Medicaid programs; quarterly listing of program issuances--third quarter 1997--HCFA. Notice.

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during July, August, and September of 1997 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this time frame.

Abstracting and Indexing↗
PubMed1998

Medicare and Medicaid programs; quarterly listing of program issuances--first quarter, 1998--HCFA. Notice.

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during January, February, and March of 1998 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed1998

Medicare and Medicaid programs; quarterly listing of program issuances--second quarter, 1998--HCFA. Notice.

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during April, May, and June of 1998 that relate to the Medicare and Medicaid programs. It also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that may be potentially covered under Medicare. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed1989

Lasers in cardiovascular medicine.

The role of lasers in cardiovascular medicine and surgery is a rapidly evolving and uncertain field. Many alternative percutaneous techniques and technologies for removal of atherosclerotic plaque are under development. However, according to many clinicians, atherectomy devices that bore through occlusions with high speed burrs, shave them away with miniature knives, or micropulverize them with ultrasonic waves will be complements not substitutes to both lasers and balloons. Thus, it is unlikely that a cost-effective substitute for the laser is likely to come from developments in mechanical ablation systems. It is important to keep in mind that peripheral laser angioplasty is still considered of benefit to a small percentage of all candidates for peripheral percutaneous transluminal angioplasty, and that coronary laser angioplasty is strictly investigational. Although more devices may be approved in the next year, only two are available on the open market at publication, and both are approved only for peripheral angioplasty. With the rapid growth in the number of laser manufacturers entering the market, there are ample opportunities for large hospitals with active cardiology and cardiovascular surgery programs to become trial sites. However, the smaller hospital set on entering the market may want to consider only well-established, FDA approved technologies that are reasonably priced.

Angioplasty, Laser↗
PubMed1999

The middle ear bioelectronic microphone for a totally implantable cochlear hearing device for profound and total hearing loss.

BACKGROUND: A bioelectronic middle ear microphone (BMEM) has been developed in a laboratory bench model and successfully tested in fresh human temporal bones. A transducer actually has been bench-tested in our laboratory; it was implanted in chronic animal experiments (cats) as well as in humans for a period of 1 year as a driver of a semi-implantable electromagnetic middle ear hearing device (IDE, FDA approved). This BMEM is the result of the use of this same electromagnetic transducer used in a reverse mode. The applicability of the BMEM is for the development of a totally implantable cochlear implant using the eardrum as a diaphragm that transmits vibrations to a magnet cemented to the ossicles. This BMEM is to be powered by a lithium-ion implantable, rechargeable battery. MATERIALS AND METHODS: To test the efficacy of this BMEM, the experiment was divided into two parts: (1) bench model, and (2) fresh human temporal bones, using an air-core electromagnetic (EM) coil and a ferrite core EM coil for comparison. RESULTS: In the bench model, the average displacement at 3 kHz was 0.95 microns (peak) for 4 V p-p and 1.65 microns (peak) for 10 V p-p. At 5 kHz, the measurements were somewhat higher. In fresh human temporal bones, with sound source in the ear canal (60 dB HL and 90 dB HL), the result was better with the magnet implanted on the head of the malleus with the incus removed. The ferrite core EM coil with the magnet implanted on the malleus with the incus removed was compared with the air-core EM coil. At 60 dB HL, the ferrite core EM coil yielded more than four times the amplitude of the EM coil. At 90 dB HL, the ferrite core EM coil produced more than five times the amplitude compared with the air-core coil. CONCLUSION: This BMEM using an EM ferrite coil and a permanent magnet on the head of the malleus is more efficient when compared with an EM air-core coil. This BMEM may be applicable to the construction of a totally implantable cochlear implant. Further research is necessary to integrate this BMEM with the other components of the design concept of the totally implantable cochlear implant.

Animals↗
PubMed1999

Medicare and Medicaid programs; quarterly listing of program issuances--third quarter, 1998. Health Care Financing Administration (HCFA), HHS. Notice.

This notice lists HCFA manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published during July, August, and September 1998, relating to the Medicare and Medicaid programs. This notice also identifies certain devices with investigational device exemption numbers approved by the Food and Drug Administration that potentially may be covered under Medicare. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this timeframe.

Centers for Medicare and Medicaid Services, U.S.↗