PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Device Approval”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 307 records · Page 17Linked to original sources
PubMed2002

Randomized comparison of Vasoseal and Angioseal closure devices in patients undergoing coronary angiography and angioplasty.

AngioSeal (AS) and VasoSeal (VS) are collagen-based arterial closure devices utilized to achieve earlier hemostasis and ambulation in diagnostic and interventional percutaneous procedures. To our knowledge, there has been no randomized studies comparing these two devices as approved for use in the United States. One hundred fifty-seven patients were randomized to receive either the 8 Fr AS (n = 79) or VS (n = 78) closure device. Data on 95 patients who had coronary angiography (49 AS, 46 VS) and 55 patients who underwent angioplasty (28 AS, 27 VS) were completed. Heparin was not administered during the coronary angiogram procedure. The activated clotting time was kept at approximately 300 sec during angioplasty. Patients on coumadin or GP IIb/IIIa platelet inhibitors were not included in this study. The time unit interval to achieve hemostasis in this study was based on the time the AS tension spring was left over the common femoral artery following collagen deployment as per the manufacturer's instructions (20 min). Time to hemostasis, time to ambulation, and major and minor complications were prospectively recorded. Two-tailed t-test and chi-square analysis were performed on continuous and dichotomous variables, respectively. For the angiogram-only subgroup, time (min) to hemostasis (20.51 +/- 4.36 vs. 18.59 +/- 11.77; P = 0.30) and ambulation (145.71 +/- 124 vs. 109.89 +/- 60.37; P = 0.075) were not statistically different for the AS and VS, respectively. Similarly, for the angioplasty subgroup, time (min) to hemostasis (24.23 +/- 12.70 vs. 19.57 +/- 2.27; P = 0.077) and ambulation (607.32 +/- 344.22 vs. 486.48 +/- 200.37; P = 0.12) were not statistically different for both AS and VS, respectively. Furthermore, there were no statistical differences in deployment failure, major, minor, or total complication rates between the two devices. In the absence of GP IIb/IIIa inhibitors, VS and the 8 Fr AS devices have statistically similar time to hemostasis and ambulation as well as device failures and complication rates following coronary angiography and angioplasty.

Aged↗
PubMed2005

A randomized, controlled trial of saphenous vein graft intervention with a filter-based distal embolic protection device: TRAP trial.

The purpose of this prospective, multicenter trial was to evaluate the safety and effectiveness of the TRAP Vascular Filtration System (VFS) to reduce embolic complications during stenting of diseased saphenous vein grafts (SVGs). Patients with SVG lesions were randomly assigned to undergo stenting with or without the TRAP device. The trial was designed to enroll 752 randomized patients. However, the sponsor terminated the study after a total of 467 patients (358 randomized) were enrolled because of poor recruitment once another distal protection device was approved for clinical use. The primary study endpoint, major adverse cardiac events at 30 days, occurred in 17.3% of control patients and 12.7% of patients treated with the TRAP device (P = 0.24). There was a trend toward a lower incidence of myocardial infarction in the TRAP group compared with the control group (16.2% vs 10.5%, P = 0.12). This difference was predominantly due to a lower incidence of moderate-large infarction (CKMB >5x) in the TRAP group. Use of the TRAP VFS during SVG intervention was safe and was associated with a trend toward a lower incidence of adverse events, however, due to low enrollment the study lacked sufficient power to detect a significant benefit with the device.

Aged↗
PubMed1987

Cochlear implants in deaf children.

The results to date with the 3M/House cochlear implant in children have been extremely encouraging. Statistically and clinically significant changes show that the implant can provide improvements in auditory detection and discrimination as well as in speech production. As with any intervention, results range from outstanding for some children (open-set speech discrimination and/or intelligible speech) to minimal for others (no stimulation or little improvement in speech). Until long-term studies can be completed, the implant will undoubtedly remain controversial. However, professionals involved in the care of a child who is hearing-impaired should be informed that the field of cochlear implantation is rapidly expanding. A number of different cochlear implants are currently undergoing clinical trials in adults. Besides the 3M/House device, the FDA has recently approved a second device, the Nucleus Multichannel Cochlear Implant, for investigation in children. The treatment of profound deafness is changing in children with the cochlear implant as an option for those not benefiting significantly from hearing aids. However, some important aspects of a deaf child's management have not changed and will not change: the need for early diagnosis and multidisciplinary management. The first five years of life are the language acquisition years. Proper management during these years is critical if the hearing-impaired child's handicap is not to dominate his or her future and limit potential for a successful, happy life.

Adolescent↗
PubMed1992

FDA regulation of dental devices: past, present, and future.

The organization of the Food and Drug Administration as related to dental devices is described. The classification according to safety and efficacy of devices is described and examples are given. The process of submitting a Premarket Notification [(510(k)] for class I and II devices, a Premarket Approval (PMA) for class III devices and an Investigational Device Exemption (IDE) are described. The clinician is told how to report problems with medical devices.

Dental Equipment↗
PubMedDate not supplied

Simpla Plus leg bag: approval by the National Customer Group.

The choice of the right product for the right patients is fundamental in the adequate care of incontinent patients: therefore, it is important that nurses and healthcare professionals are aware of all the products that are available and that these products meet the required standards. The Simpla Plus leg bag, manufactured by Coloplast, is an example of one such product which has been officially approved by the National Customer Group for inclusion in the NHS purchasing and supply contract.

Consumer Organizations↗
PubMed2006

Standards for humidification and filtration devices.

This synopsis of the background to the standardization of medical devices allows a comparison of the functional operation of two regulatory authorities, the FDA and the European Commission. It can be seen that with time they have developed many common features. However, there remains a significant difference with the older style of regulation imposed by the FDA, in particular the obligation to comply with USA Federal Law and Federal Codes of Regulation. Further, the FDA expects manufacturers, when submitting medical devices for approval, to provide their own supportive evidence by showing compliance with ISO and IEC good manufacturing practice and safety standards. Finally, it is only pragmatic to accept that marketing permission for all devices is ultimately overseen, inspected and enforced solely by the FDA. By comparison, within Europe it is the more modern Medical Device Directives of the European Commission that are the statutory legislation. In order to market a medical device, the only fundamental responsibility of the manufacturer is that it must have a CE marking, which is achieved by showing compliance with the Essential Requirements. One means of accomplishing this is to conform with the provisions of relevant harmonized standards. Such concurrence may be verified if needed, by one of the international pool of independent Notified Bodies, who are ultimately overseen by the Competent Authorities of the individual States of the Community. The preparation of standards for medical devices is a slow process, involving the cooperation of the multiple stakeholders with an interest in the device. They are expected to produce a final document that is fair, consistent and practical for all the parties involved, from the initial designer to the final patient to whom the device is attached. Analysis of the three standards applicable to humidifiers, HME and BSF demonstrates some of the difficulties encountered in meeting these obligations. It is to be hoped that the solutions which were found achieve the ultimate goal of all medical device standards-specifically that the equipment should not cause a hazard to either the patient or user. But it is interesting to wonder whether it can be shown that any BSF meets one of the prime requirements of the FDA, to wit that all medical devices must be able to demonstrate efficacy. There is a dearth of clinical trials supporting the allegation of BSF manufacturers that the routine use of these devices improves patient care, which can only be taken to mean that to date such claims are difficult to vindicate. This paralogism must be countered by the indisputable fact that BSF can significantly increase the work of breath-ing, enlarge the deadspace and even, as has been shown recently, result ina complete blockage of the breathing system. Whatever standards are in place with reference to any particular medical device, it must never be forgotten that it is only the clinician who will finally be accountable for the safe and effective operation of the equipment. While caveat emptor must always be the shibboleth of the purchaser, statutory or advisory regulations are no defense for an incompetent user.

Canada↗
PubMed2003

FDA approves new rapid HIV test.

The Food and Drug Administration has approved a new rapid HIV diagnostic test kit that provides results with 99.6% accuracy in as little as 20 minutes.

AIDS Serodiagnosis↗
PubMed2001

ACOG Committee Opinion. Number 258, September 2001. Fetal pulse oximetry.

The U.S. Food and Drug Administration recently approved the marketing of the Nellcor N-400 Fetal Oxygen Saturation Monitoring System, a fetal pulse oximeter. The American College of Obstetricians and Gynecologists Committee on Obstetric Practice cannot endorse the adoption of this device in clinical practice at this time because of concerns that its introduction could further escalate the cost of medical care without necessarily improving clinical outcome. The committee recommends that prospective randomized clinical trials be conducted to evaluate the clinical use of this new technology in conjunction with fetal well-being assessment.

Device Approval↗
PubMed2001

Bridge to transplant with the HeartMate device.

The incidence and prevalence of chronic heart failure continues to increase, with an estimated 400,000 new cases per year in the United States. Cardiac transplantation is an effective therapy but is severely limited to approximately 2300 patients per year due to the donor shortage. With ever increasing waiting times, a significant number of patients become severely debilitated or expire prior to transplantation. A mechanical circulatory support device was first used as a "bridge to transplantation" in 1969. Since then, mechanical devices have increased tremendously in reliability and efficaciousness. The HeartMate left ventricular assist device (LVAD) has been utilized extensively in a bridge to transplant application with excellent results. Patients refractory to aggressive medical management can be sustained reliably until transplantation. In addition, bridging allows for the correction of physiologic and metabolic dearrangements often seen in these severely ill patients prior to transplantation. Nutritional, economic, and quality-of-life issues also favor earlier LVAD placement in refractory patients. This reportsummarizes the overall bridging experience with the HeartMate LVAD and focuses on our experience with this device at Rush-Presbyterian-St. Luke's Medical Center.

Adolescent↗
PubMed1998

Approval of an alternative requirement of the Mammography Quality Standards Act; availability--FDA. Notice.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Approval of an Alternative Requirement of the Mammography Quality Standards Act" (the MQSA). The MQSA final regulations require that the collimation of the mammography unit permit the x-ray field to extend to or beyond the edges of the image receptor. FDA has approved a request from General Electric (GE) Medical Systems for an alternative to the MQSA requirement to apply to GE Senographe mammographic systems.

Device Approval↗
PubMed2001

Drug treatments and topics: the year in review.

In 2000, more than 100 new drugs and devices were approved for use in the United States. Many drugs were reformulated to provide new uses, more effective dosing, or improved costs. In an effort to ensure safe prescribing practices, the Food and Drug Administration has increased drug and device monitoring and services available to clinicians.

Administration, Inhalation↗
PubMed2004

Endograft technology: highlights of the past 10 years.

The past decade has seen the evolution of an exciting technology that has changed forever the treatment of aortic aneurysmal disease. From rather crude homemade stent-grafts constructed in the surgical suite to elegant commercially manufactured devices in a variety of configurations and sizes, the aortic endograft has experienced a meteoric rise in popularity to become a beneficial, minimally invasive therapy that can obviate the risk of rupture and death. There are now 3 approved endovascular devices on the market for infrarenal abdominal aortic aneurysm repair, and it is likely that additional and improved devices will become available in the future. This review revisits the developmental history of the aortic endograft, noting the ongoing refinements that have arisen from our experiences with the growing population of stent-graft patients. Although research continues to search for solutions to the problems of endoleak and migration, long-term results even with the earlier second and third-generation devices are better than has been achieved with open surgical repair.

Aortic Aneurysm, Abdominal↗
PubMed2000

The Molteno M-Sphere.

PURPOSE: To analyze a mammalian hydroxyapatite (HA) implant known as the Molteno M-Sphere, recently approved by the Food and Drug Administration of the United States. METHODS: The authors examined the implant macroscopically, with chemical analysis (x-ray powder diffraction, x-ray fluorescence spectrophotometry), and microscopically with scanning electron microscopy. Animal implantation of six Molteno M-Spheres was carried out in six adult male New Zealand albino rabbits. Implant vascularization was evaluated by means of magnetic resonance imaging and histopathologic sectioning. RESULTS: The M-Sphere was found to have multiple interconnected pores throughout with an average pore size of 300 microm to 600 microm. This implant was very light-weight (0.31 g) and fragile. It was made up of pure HA. Magnetic resonance imaging studies showed implant enhancement to its center by 4 weeks after implantation. Histopathologically, fibrovascularization occurred uniformly throughout the 4, 8, and 12-week rabbit implants. CONCLUSIONS: The M-Sphere is an alternative type of HA implant that recently has been reintroduced into the United States for use after enucleation, evisceration, or as a secondary implant. It has multiple interconnected pores allowing central fibrovascularization as early as 4 weeks in a rabbit model. Its light weight and fine trabecular framework, however, are associated with increased implant fragility when compared with other available HA implants (BioEye and FCI3 synthetic HA). The implant requires careful handling because routine handling may damage the implant. The implant is currently approved by the United States Food and Drug Administration.

Animals↗