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At least 343 records · Page 19Linked to original sources
PubMed1997

[Principle requirements of an electromechanical transducer for implantable hearing aids in inner hearing hearing loss. II: Clinical aspects].

In cases of sensorineural hearing loss, an electromechanical transducer of implantable hearing aids should partially or completely compensate for the cochlea amplifier (CA) failure that occurs in most of these patients. CA failure can be clinically identified by a positive recruitment and amplitude loss in otoacoustic emissions (OAE). In a healthy ear, the basis of the CA is the motility of the outer hair cells. A transducer that replaces functions of the CA can be termed CAI (cochlea amplifier implant). A CAI should fulfill five requirements: (1) production of a vibratory output signal, (2) reinforcement of the travelling wave in the inner ear, (3) imitation of the physiological, nonlinear behavior of the CA, (4) reinforcement without distortion, and (5) steady amplitude at rising frequencies. Compensation of frequency selectivity of the CA would also be desirable; however, this can hardly be expected from an implant. If the requirements are fulfilled, one can expect superior sound and hearing quality compared to a conventional hearing aid. Frequency should range from 50 to 10,000 Hz and have an increasing transfer function beyond 1000 Hz. Equivalent levels in the high frequency range should clearly exceed 100 dB SPL. Total distortion should at best amount to 1%. The CAI should function as a totally implantable hearing aid requiring minimum energy. The outer ear canal has to remain open so that occlusion cannot occur; the ossicular chain should be kept intact or repairable, and the implantation technique should allow explantation. The quality of the implant should make possible a CE approval in Europe and an FDA approval in the USA. Furthermore, there should be no risks involved if computer tomography, MRI, or PET examination are undertaken. Underwater diving to a depth of 2-3 m should also be permissible. Minimization of risks that occur near strong magnetic fields or high frequency fields is of great practical importance.

Cochlear Implants↗
PubMedDate not supplied

Understanding pre-market approval and labeling differences of two leading customized ablation platforms: a call for reform at the FDA.

PURPOSE: To analyze the Food and Drug Administration (FDA) pre-market approval reported data for two currently available wavefront-guided excimer laser systems. METHODS: VISX and Alcon myopic wavefront laser in situ keratomileusis (LASIK) trials were analyzed based on public information available in the pre-market approval documents. RESULTS: Clinical tests and outcomes reporting varied between pre-market approvals. One pre-market approval reported contrast sensitivity whereas the other did not, although data was collected in both studies. Based on the FDA definition of "accountability," one pre-market approval reported 12-month accountability of 97.7% although only 24.5% of patients were analyzed at that interval. One pre-market approval reported 6-month results whereas the other reported 6- and 12-month results. One pre-market approval reported grouped pre- and postoperative subjective survey results; the other reported individual changes in pre- to postoperative subjective symptoms. CONCLUSION: We recommend an FDA revision to the definition of "accountability" and also recommend future FDA refractive surgery trials be guided by standardized criteria.

Clinical Trials as Topic↗
PubMed2002

Initial experience with cerebral protection devices to prevent embolization during carotid artery stenting.

OBJECTIVE: Carotid artery stenting (CAS) for treatment of carotid stenosis has not received wide acceptance because of the availability of carotid endarterectomy (CEA) with its excellent results and because of the risk of embolic stroke associated with CAS. The feasibility and efficacy of cerebral protection devices that may prevent such embolic complications have yet to be shown. We report our initial results with CAS performed with cerebral protection. METHODS: For a period of 28 months, 31 patients with carotid artery stenosis, most of whom were considered at high risk for CEA (87%), underwent treatment with CAS in conjunction with either the PercuSurge GuardWire (n = 19; Medtronic, Minneapolis, Minn), the Cordis Angioguard filter (n = 7; Cordis, Warren, NJ), or the ArteriA Parodi Anti-embolization catheter (n = 4; ArteriA, San Francisco, Calif) with US Food and Drug Administration-approved investigational device exemptions. Factors that made CEA high risk included restenosis after CEA (n = 6), hostile neck (n = 6), high or low lesions (n = 4), and severe comorbid medical conditions (n = 11). Preoperative neurologic symptoms were present in 58%, and the mean stenosis was 85% +/- 12%. Data were prospectively recorded and analyzed on an intent-to-treat basis. Neurologic evaluation was performed before and after CAS by a protocol neurologist. RESULTS: CAS was performed with local anesthesia with the Wallstent (n = 23; Boston Scientific Corp, Natick, Mass) or the PRECISE carotid stent (n = 7; Cordis) in conjunction with one of the protection devices in an operating room with a mobile C-arm. Each patient received dual antiplatelet therapy before surgery. The overall technical success rate was 97% (30/31). In one patient, the lesion could not be crossed with a guidewire because of a severely stenosed and tortuous lesion. This patient was not a candidate for CEA and was treated conservatively. In the remaining 30 cases, CAS had a good angiographic result (residual stenosis, <10%). All patients tolerated the protection device well, and no intraprocedural neurologic complications occurred. Macroscopic embolic particles were recovered from each case. One patient (3%) with a severely tortuous vessel had a major stroke immediately after CAS, and no deaths occurred. The combined 30 day stroke/death rate was 3%. During a mean follow-up period of 17 months, one subacute occlusion of the stent occurred but did not result in a stroke. Three other patients had duplex scan-proven in-stent restenosis, and two underwent treatment with repeat percutaneous transluminal angioplasty with a good result. No patient had a stroke during the follow-up period. CONCLUSION: CAS with cerebral protection devices can be performed safely with a high technical success rate. Although many patients who underwent treatment with CAS were at high risk, the neurologic complication rate was low and CAS appears to be an acceptable treatment option for select patients at high risk for CEA. Tight lesions and tortuous anatomy may make the use of distal protection devices difficult. Further study is warranted.

Aged↗
PubMed1996

The changing environment for technological innovation in health care.

A distinguishing feature of American health care is its emphasis on advanced technology. Yet today's changing health care environment is overhauling the engine of technological innovation. The rate and direction of technological innovation are affected by a complex of supply- and demandside factors, including biomedical research, education, patent law, regulation, health care payment, tort law, and more. Some distinguishing features of technological innovation in health care are now at increased risk. Regulatory requirements and rising payment hurdles are especially challenging to small technology companies. Closer management of health care delivery and payment, particularly the standardization that may derive from practice guidelines and clamping down on payment for investigational technologies, curtails opportunities for innovation. Levels and distribution of biomedical research funding in government and industry are changing. Financial constraints are limiting the traditional roles of academic health centers in fostering innovation. Despite notable steps in recent years to lower regulatory barriers and speed approvals, especially for products for life-threatening conditions, the Food and Drug Administration is under great pressure from Congress, industry, and patients to do more. Technology gatekeeping is shifting from hundreds of thousands of physicians acting on behalf of their patients to fewer, yet more powerful, managed care organizations and health care networks. Beyond its direct effects on adoption, payment, and use of technologies, the extraordinary buying leverage of these large providers is cutting technology profit margins and heightening competition among technology companies. It is contributing to unprecedented restructuring of the pharmaceutical and medical device industries, leading to unprecedented alliances with generic product companies, health care providers, utilization review companies, and other agents. These industry changes are already having considerable effects on investment patterns and the development, adoption, and use of new technologies. Until recently, new technologies that offered the prospect for health benefit, however, marginal or unproven, were paid for with little or no regard to cost. Technical wizardry alone no longer carries the day in health care. Today's health care market increasingly demands what other markets do--measurable improvements in benefits at acceptable costs--and innovators have begun to respond accordingly. Even so, certain key venues for health care innovation are at risk.

Biomedical Technology↗
PubMed2003

An overview of drug development in the United States and current challenges.

Drug development in the United States has undergone many changes in the past 25 years, but relatively few fully realize the complexities involved in developing a new drug. Once a promising compound is identified, it must undergo preclinical testing, have an Investigational New Drug Application filed with the U.S. Food and Drug Administration (FDA), and proceed through clinical testing. When sufficient information is gained, a marketing application is filed with the FDA, who identifies it as a New Drug Application for drugs or a Biologics License Application for biologics. After FDA review and approval, postmarketing studies are frequently performed. The FDA and Congress have undertaken several initiatives to expand access and to accelerate drug development and review of investigational drugs for life-threatening and/or serious illnesses. Although the ultimate goal is to bring safer and more effective medical products to patients in a timely manner, multiple challenges face those who participate in drug development.

Clinical Trials as Topic↗
PubMedDate not supplied

Robot-assisted surgery: the future is here.

According to L. Wiley Nifong, director of robotic surgery at East Carolina University's Brody School of Medicine, "Nationally, only one-fourth of the 15 million surgeries performed each year are done with small incisions or what doctors call 'minimally invasive surgery'." Robots could raise that number substantially (Stark 2002). Currently, healthcare organizations use robot technology for thoracic, abdominal, pelvic, and neurological surgical procedures. Minimally invasive surgery reduces the amount of inpatient hospital days, and the computer in the system filters any hand tremors a physician may have during the surgery. The use of robot-assisted surgery improves quality of care because the patient experiences less pain after the surgery. Robot-assisted surgery demonstrates definite advantages for the patient, physician, and hospital; however, healthcare organizations in the United States have yet to acquire the technology because of implementation costs and the lack of FDA (Food and Drug Administration) approval for using the technology for certain types of heart procedures. This article focuses on robot-assisted surgery advantages to patients, physicians, and hospitals as well as on the disadvantages to physicians. In addition, the article addresses implementation costs, which creates financial hurdles for most healthcare organizations; offers recommendations for administrators to embrace this technology for strategic positioning; and enumerates possible roles for robots in medicine.

Device Approval↗
PubMed2003

Using the MADIT II criteria for implantable cardioverter defibrillators-what is the role of the Food and Drug Administration approval?

The results of the MADIT II study have generated a great deal of controversy in the world of electrophysiology. Much of the controversy appears related to the sheer numbers of potential Implantable Cardioverter Defibrillator (ICD) implants and their potential cost to the healthcare system. Two federal regulatory agencies, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have been highly visible in discussions. The FDA approved the MADIT II indications for Guidant ICDs, while CMS covered a limited subset of the patients studied. This review explores some the issues surrounding the trial and the key participants in this discussion with emphasis on the role of the Food and Drug Administration (FDA) and how regulatory decisions may impact on clinical practice.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed2005

Automated external defibrillators for home use.

The Philips HeartStart Home Defibrillator is an automated external defibrillator (AED) that is approved for home use by untrained users. Most cardiac arrests occur in the home, so a rapid response with cardiopulmonary resuscitation (CPR) and defibrillation is critical for survival. No prospective studies demonstrate that the use of AEDs in the home by untrained persons improves health outcomes. Further investigation is needed to determine the benefit and harm of AEDs in the home.

Adult↗
PubMedDate not supplied

Evidence, appropriateness, and technology assessment in cardiology: a case study of computed tomography.

As the volume, complexity, and cost of new medical technology increase, the need for evaluating benefits and risks becomes increasingly important. Once the formal requirements for Food and Drug Administration approval and insurance coverage are met, however, few systematic criteria are applied to ensure patient benefit. A more systematic policy approach regarding new technologies is needed, with input from balanced groups reviewing evidence of clinical outcomes data to determine patient benefit. This paper examines cardiac computed tomography angiography as a case study; it proposes procedures designed to ensure that the benefits of new technologies justify their costs.

Angiography↗
PubMed1997

FDA weighs policing electronic patient record.

New regulations now being considered by the Food and Drug Administration (FDA) could affect the software you use to run your electronic patient record and electronic clinical pathway systems. The standards would impose a federal approval process on all computerized medical record programs and financial systems currently in use at hospitals. The FDA's primary focus is on commercially developed software. Although some worry that the agency will also attempt to regulate software developed in-house by hospitals, it's now likely that such software will be exempted from regulation. Although the agency has not released a final version of the regulatory standards, FDA officials expect action to be taken within the next few months.

Computer Security↗
PubMed2001

Comparison of methods of bag and mask ventilation for neonatal resuscitation.

BACKGROUND: There are a variety of manual bagging devices used for neonatal resuscitation. To our knowledge, there has been no comparison of the ability of different operators to utilize such devices for the delivery of predetermined inspiratory and end-expiratory pressures. In addition, the use of prolonged inflation may be of benefit for infants who require bag and mask ventilation, and there has been no evaluation of the ability of a variety of operators to reliably deliver such breaths using currently available equipment. METHODS: We utilized a neonatal manikin (Laerdal Armonk, NY) with a functional larynx and lungs, and a clear cushioned mask (Owens-BriGam, Morganton, NC). We studied a latex-free disposable anesthesia type bag (Model 5126 Vital Signs, Totawa, NJ), a Jackson-Rees (JR) type anesthesia bag (Model E191 Anesthesia Associates, San Marcos, CA) fitted with a Norman elbow and a flow-control tail-piece (Dupaco, Oceanside, CA), and the Neopuff (Fisher and Paykel, Auckland, New Zealand), an FDA approved mechanical device that is flow-controlled and pressure-limited, specifically designed to facilitate neonatal resuscitation. The ventilating pressures were continuously recorded throughout the process. We evaluated neonatal nurses, neonatal nurse practitioners, neonatal staff and fellows, pediatric residents and neonatal respiratory therapists. RESULTS: The peak inspiratory pressure (PIP) was significantly different between operators using either anesthesia bag, P<0.001. Similar results were found for positive end-expiratory pressure (PEEP) with a significant difference among the operator groups, P<0.001. All the differences in post hoc analysis were between the therapists and the other groups, P<0.05. Therapists produced significantly higher pressures than the other groups for both PIP and PEEP (P<0.001). The PIP was similar for all groups using the Neopuff device. The PIP and PEEP delivered by the Neopuff differed from the other two devices independent of the operators (P<0.05). On post hoc analysis, there was a significant difference between the disposable anesthesia bag and Neopuff for both PIP and PEEP for the therapists, whereas among the non-therapists, there was a difference in PIP with the JR device producing a greater PIP (26.6+/-3.8 cmH(2)O) compared with the Neopuff and disposable anesthesia bag (24.8+/-1.1 cmH(2)O, 24.8+/-4.3 cmH(2)O). The level of PEEP was significantly different among all three devices for the non-therapists (1.3+/-1.6 cmH(2)O, Disposable; 2.9+/-1.2 cmH(2)O, JR; 4.7+/-0.5 cmH(2)O, Neopuff; P<0.05). Only the therapists were able to consistently deliver PEEP with the anesthesia bags, whereas all operators could generate the target PEEP with the Neopuff (P<0.05). We compared the pressure delivered during the first second to the pressure delivered during the fifth second during prolonged 5-s inflations. The absolute differences between the first and fifth second for the Neopuff versus the anesthesia bags were significantly different with a median of 7.1 cmH(2)O for the anesthesia bags compared with 0.2 cmH(2)O for the Neopuff, P<0.001, reflecting the difficulty in obtaining and maintaining the target inflation pressures. CONCLUSIONS: Our experience suggests that the Neopuff, a purpose-built neonatal resuscitator ventilator, facilitates the delivery of the desired airway pressures while maximizing the operators ability to obtain and maintain a patent airway, and facilitates the delivery of prolonged inflations. Further research is required to determine the clinical benefit of end-expiratory pressure and prolonged inflations in neonatal resuscitation.

Analysis of Variance↗
PubMed2004

Surgical robotics in otolaryngology: expanding the technology envelope.

PURPOSE OF REVIEW: Surgical robotics arose as an extension of virtual reality and robotic technology developed by the United States Department of Defense. Current surgical robotic systems have been used to perform a variety of minimally invasive surgical procedures. RECENT FINDINGS: The Food and Drug Administration recently granted approval for the clinical use of two surgical robotic systems. Laboratory and clinical experience suggests that the use of surgical robotics is associated with some distinct advantages and disadvantages when compared with conventional open procedures. Robotic surgery has recently been described in the head and neck, and as a result the otolaryngologist should have a basic understanding of the potential applications of surgical robotics in head and neck surgery. SUMMARY: Surgical robotic technology is evolving but appears to have a distinct place in the surgical armamentarium.

Animals↗
PubMed1995

Long-term clinical results of AMO PhacoFlex model SI-18 intraocular lens implantation.

The AMO PhacoFlex Model SI-18 was the first commercially available three-piece silicone intraocular lens (IOL) for use in small incision cataract surgery. Allergan Medical Optics' silicone IOLs have been implanted in more than 750,000 patients worldwide over the past eight years. This report of the FDA clinical investigation of the AMO PhacoFlex model SI-18 IOL summarizes one year follow-up data from the initial premarket approval clinical trial on 500 core patients implanted with the SI-18 lens. One-year follow-up data from 5,860 patients in the modified core group and three-year follow-up data on the 500 patient core/modified core group are also presented. At three years postoperatively, 91.3% of best case core/modified core patients achieved 20/40 or better corrected visual acuity. Overall incidence of persistent complications at three years was 3.2%.

Aged↗
PubMedDate not supplied

[Artificial discs: review, current status, outlook].

AIM: This paper gives an overview of the current status of artificial discs for the lumbar spine. METHODS: Recent publications and overviews in the literature with pro and contra opinions and the latest procedure of FDA approval are presented and discussed. Despite arguments to the contrary, an FDA panel is in favour of the premarket approval application for the Charité artificial disc because of good late follow-up results. Other lumbar artificial discs will follow. RESULTS: Follow-up studies only exist for the Charité and Prodisc endoprotheses. The results are comparable to those of lumbar fusion. However, randomized controlled studies are still missing. CONCLUSION: Proponents for lumbar artificial discs stand against the criticism of an unpredictable treatment for a condition that cannot be diagnosed with any precision. The current model should be a controlled indication with second opinions followed by professional surgery in spine centers.

Clinical Trials as Topic↗
PubMed1993

French homologation for medical devices: past and future.

The French approval procedure for medical devices, known as homologation, is considered to be one of the most complicated national approval processes in Europe. This article outlines some of the key elements of homologation and the major changes that have been introduced since 1991. In addition, homologation will not survive in its present form when the EC Directives come into force. The author outlines current expectations.

Clinical Trials as Topic↗
PubMed2007

Status of toric intraocular lenses.

PURPOSE OF REVIEW: To provide an update on the status of toric intraocular lenses. These lenses can be used as an alternative or adjunct to corneal astigmatic incisions for correcting preexisting astigmatism in patients with cataracts. They are a particularly attractive option in those cases where limbal-relaxing incisions are not powerful or predictable enough. Other toric lenses may correct astigmatism in addition to spherical refractive errors in phakic patients. RECENT FINDINGS: Toric lenses have continued to gain popularity with the US Food and Drugs Administration (FDA) approval of the Acrysof Toric intraocular lenses. This lens is designed to be implanted in patients undergoing cataract removal and who have significant preexisting corneal astigmatism. In the FDA clinical trial, study patients received one of the three cylindrical powers, and control patients received a standard monofocal intraocular lenses. The study found that the Acrysof Toric intraocular lenses provided excellent visual outcomes and exhibited excellent rotational stability. With the Acrysof Toric intraocular lenses, the average lens rotation was less than 4 degrees from the lens' initial placement at 6 months after surgery. SUMMARY: Toric intraocular lenses provide excellent vision for astigmatic cataract patients, and new designs are significantly improving visual acuity by minimizing the risk of rotation.

Astigmatism↗
PubMed2001

Vagus nerve stimulation in pediatric epilepsy: a review.

Therapeutic options for intractable epilepsy include new and investigational antiepileptic drugs, ketogenic diet, epilepsy surgery, and, now, vagus nerve stimulation, which is approved by the U.S. Food and Drug Administration for the treatment of refractory partial seizures in adolescents and adults. The exact mechanisms of action are unknown. Although the use of vagus nerve stimulation in children has increased, including those younger than 12 years of age or those with generalized epilepsy, there has been no large controlled pediatric study to date. The identification of favorable prognostic indicators, especially in children, would be useful. Preliminary results suggest that children with Lennox-Gastaut syndrome may have a favorable response, with improvement in both seizure control and global evaluation scores. Improved global evaluation scores have occurred even without an associated improvement in seizure control.

Adolescent↗