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At least 73 records · Page 4Linked to original sources
PubMed2000

Comparison of two commercially available near-infrared spectroscopy instruments for cerebral oximetry. Technical note.

Two near-infrared spectroscopy (NIRS) devices were compared with regard to their responses to changes in cerebral hemoglobin oxygenation induced by hypoxia and hypercapnia in five healthy volunteers. Sensors belonging to each NIRS device were placed on opposite sides of the volunteer's forehead. The INVOS-3100A device, approved by the United States Food and Drug Administration, records the percentage of oxyhemoglobin (HbO2) saturation and the investigational NIRO500 device records absolute changes in HbO2, deoxyhemoglobin, and total hemoglobin in micromolar concentrations referenced to an arbitrary baseline. The volunteers breathed separate mixtures of 7% CO2 in O2 and 10% O2 for 5 minutes in random order. Arterial blood pressure, end-tidal CO2 (ETCO2), arterial O2 saturation, and electrocardiographic data were continuously monitored. Hypercapnia increased (p < 0.01) ETCO2 from 42+/-2 to 56+/-3 mm Hg (mean +/- standard deviation), resulting in a 7.3+/-0.2% increase (p < 0.005) in cerebral HbO2 saturation detected by the INVOS3100A device and an 11.6+/-3 microM increase (p < 0.0008) in HbO2 detected by the NIRO500. Hypoxia decreased (p < 0.01) arterial HbO2 saturation from 98+/-1 to 87+/-3%, causing a 5.1+/-1.2% decrease (p < 0.01) in the percentage of HbO2 saturation detected by the INVOS3100A device and a 9.7+/-6.3 microM decrease in HbO2 detected by the NIRO500. The responses of the NIRO500 and the INVOS3100A instruments to changes in cerebral oxygenation resulting from hypercapnia and hypoxia were generally similar; however, responses tended to be greater when recorded by the NIRO500 device, perhaps because, unlike the INVOS3100A device, the NIRO500 does not correct for skin and bone contamination.

Blood Gas Monitoring, Transcutaneous↗
PubMed2000

Percutaneous interventional approaches to diseases of the aorta.

Diseases of the aorta are prevalent in the Western world. Pathophysiology is influenced by hypertension, atherosclerosis, and genetic factors. The rupture of an aortic aneurysm or the dissection of a hematoma into the aortic wall causes significant mortality in this country. Physicians have long wrestled with therapies to prevent this fatal natural history. It was not until the surgical insertion of aortic grafts in the 20th century that effective therapy was developed. However, surgical mortality and morbidity still remain quite significant in the higher risk population in which these procedures often must be performed. During the 1990s, techniques and devices have been developed which allow placement of endovascular grafts into the aorta percutaneously, without traditional surgery. Two recently FDA-approved devices require a team approach for optimal deployment and care. In the initial experience, these endovascular devices appear to offer the promise of effective treatment with low procedural complications.

Angioplasty, Balloon↗
PubMed2001

Evaluation of a bioadhesive device for the management of aphthous ulcers.

BACKGROUND: Aphthous ulcers are common and painful. Current treatments are palliative and focused on pain reduction. This article reports on the clinical trials of a novel, bioadhesive treatment modality. METHODS: Formulations of 2-octyl cyanoacrylate, or 2-OCA, tissue adhesive were tested in two blinded, sham-controlled studies. A total of 200 patients with a single, painful aphthous ulcer were entered. In the first study, the investigators applied the tissue adhesive to the aphthous ulcers; in the second trial, the subjects themselves applied the tissue adhesive to their ulcers. The authors evaluated the safety, pain reduction and healing times associated with the bioadhesive. RESULTS: The bioadhesives were found to be safe with no significant adverse events. The short- and long-term pain reduction achieved with an investigator-applied adhesive was significant compared with that achieved with a sham device (P = .024 and P = .036, respectively). The investigator-applied adhesive also demonstrated a significant reduction in healing time over the sham device (P = .021). In the definitive trial, in which the subjects themselves applied the tissue adhesive, pain reduction with a predicate device approved by the U.S. Food and Drug Administration and with the bioadhesive was significantly better than with a sham application (P < .05). The active devices were not statistically different from each other (P = .37). No difference in healing time was evident between devices and the sham. CONCLUSIONS: The formulations of 2-OCA tissue adhesives tested were safe and demonstrated statistically significant pain reduction when applied by either the investigators or the subjects. CLINICAL IMPLICATIONS: Our clinical trials indicate that these novel tissue adhesives could be used as nonprescription, over-the-counter devices to provide significant pain relief for patients suffering from aphthous ulcers.

Administration, Topical↗
PubMed1993

Results using the biofragmentable anastomotic ring for colon anastomosis.

The Biofragmentable Anastomotic Ring (BAR) (Valtrac, Davis & Geck, Inc.) is a newly approved device intended for colonic anastomosis. We have used the device in 47 patients to date. These patients were studied to determine the effectiveness, uses and limitations of this new device. The BAR is similar in concept to the older Murphy "Button" used circa World War I, but it's constructed of polyglycolic acid rather than metal. Anastomosis is effected by placing the two bowel lumens over the device, tying the purse-string sutures snugly, and "clicking" the device closed. The BAR fragments and is passed 2 to 3 weeks postoperatively. The patients ranged from 14 to 82 years of age. Thirty-nine patients were operated on for cancer, four for diverticulitis, and four for colostomy closure. One transverse colectomy (THC), 15 left hemicolectomies (LHC), 23 sigmoid colectomies (SC), two low anterior resections (LAR), four colostomy closures, and two right hemicolectomies were performed. There were no anastomotic leaks and no complications. We found that because of the need to have access distally to "click" the device closed, BAR anastomosis after LAR is rarely feasible. Because of the small lumenal size of the distal ileum, the BAR is seldom usable for ileocolonic anastomosis after right hemicolectomy (RHC). The newly approved 25-mm BAR may change this. We found that the time required to perform an anastomosis with the BAR is equivalent to stapled techniques. At our hospital, the cost of the device is equivalent to one intestinal stapler. Since multiple staplers are used in most colon anastomotic techniques, there is a modest cost advantage for the BAR.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed2001

Practical issues and concepts in vagus nerve stimulation: a nursing review.

Estimates of epilepsy incidence among the U.S. population range between 0.5% and 1%. The most common type of seizure in adult patients is partial onset. Approximately 20% of these patients are refractory to antiepileptic drug therapy and experience intolerable side effects such as confusion, dizziness, weight gain, lethargy, and ataxia. The ketogenic diet appears to be beneficial for children but is not considered a standard option for adults. Epilepsy surgery can be an option for many and may offer control or a reduction in seizures. However, many patients are opposed to cranial surgery or may not tolerate the ketogenic diet. Recent advances in biomedical technology and perfection in surgical techniques have shown vagus nerve stimulation (VNS) using the Neuro Cybernetic Prosthesis (NCP) system is an effective new treatment option in reducing seizure frequency. On July 16, 1997, the U.S. Food and Drug Administration (FDA) approved the use of the NCP for vagus nerve stimulation, as an adjunctive treatment for refractory partial onset seizures in adults and adolescents over 12 years of age. Murphy et al. and Wheless have reported similar results in children younger than 12 years. VNS represents the first therapy using a medical device approved by the FDA for the treatment of refractory seizures. An estimated 10,000 patients have been implanted with the device.

Adolescent↗
PubMed2002

Robotic surgery: is it for you?

Robotic surgery has indeed arrived. The approved device in the United States, the Intuitive Surgical System's daVinci System, is installed in about 80 hospitals worldwide. That number is rising rapidly. Once other companies, Computer Motion for example, receive Food and Drug Administration approval for their systems, the number of robotic-equipped operating rooms will begin to increase enormously. The current outcry regarding the expense of these systems is certainly not without merit. However, I would urge surgeons interested or even just curious about these systems to try one in a laboratory setting. The ease of accomplishing difficult tasks and the vividness of the 3-dimensional imaging create an experience that is both extremely impressive and enjoyable. There are currently no data to justify the expense of these systems in terms of patient outcomes or reduced complications. Such data will take a great deal of time and effort to accumulate. However, having become accustomed to the robotic system, this surgeon would have difficult moving back to standard laparoscopic instrumentation. Imagine during a standard open operation that your scrub assistant rubbed grease on your glasses and took away your favorite forceps and needle holder and gave you clumsy instruments 18 inches too long with less-than-reliable action at the tips. With enough struggling you would be able to accomplish the operation, and perhaps over time, even become facile with subpar instruments. However, you would certainly rather see well and have the instruments that you know work best in your hands. It would be very difficult to design a study to prove that your patients are better off when you use your normal instruments and clean glasses as opposed to fogging glasses and difficult-to-use instruments. But, you would know that there is a difference. That in large part is the feeling of surgeons who have had the good fortune of becoming accustomed to the current robotic systems for minimally invasive surgery. They can see much better and can manipulate tissue much better. Most of them are also convinced that when they can see better and manipulate tissue better, the outcomes for their patients are better. Is robotic surgery right for you? The answer is complex and has a myriad of elements. This author would suggest that a great start in determining the answer would be to try the current systems and keep track of both the literature and the technical evolution regarding these systems as time progresses.

Humans↗
PubMedDate not supplied

FDA recognition of consensus standards in the premarket notification program.

"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices," Center for Devices and Radiological Health's (CDRH) Donald E. Marlowe and Philip J. Phillips note in the following article, highlighting the latest U.S. Food and Drug Administration (FDA) plans for use of standards. They note that the important role standards can play has been reinforced as part of FDA reengineering efforts undertaken in anticipation of an increased regulatory work-load and declining agency resources. As part of its restructuring effort, the FDA announced last spring that it would recognize some consensus standards for use in the device approval process. Under the new 510(k) paradigm--the FDA's proposal to streamline premarket review, which includes incorporating the use of standards in the review of 510(k) submissions--the FDA will accept proof of compliance with standards as evidence of device safety and effectiveness. Manufacturers may submit declarations of conformity to standards instead of following the traditional review process. The International Electrotechnical Commission (IEC) 60601 series of consensus standards, which deals with many safety issues common to electrical medical devices, was the first to be chosen for regulatory review. Other standards developed by nationally or internationally recognized standards development organizations, such as AAMI, may be eligible for use to ensure review requirements. In the following article, Marlowe and Phillips describe the FDA's plans to use standards in the device review process. The article focuses on the use of standards for medical device review, the development of the standards recognition process for reviewing devices, and the anticipated benefits of using standards to review devices. One important development has been the recent implementation of the FDA Modernization Act of 1997 (FDAMA), which advocates the use of standards in the device review process. In implementing the legislation, the FDA published in the Federal Register a list of standards to which manufacturers may declare conformity. Visit AAMI's Web site at www.aami.org/news/fda.standards for a copy of the list and for information on nominating other standards for official recognition by the agency. The FDA expects that use of standards will benefit the agency and manufacturers alike: "We estimate that in time, reliance on declarations of conformity to recognized standards could save the agency considerable resources while reducing the regulatory obstacles to entry to domestic and international markets," state the authors.

Equipment Safety↗
PubMed2006

Testing methods for MR safety and compatibility of medical devices.

Magnetic resonance (MR) safety and image compatibility are important issues when using medical devices in the environment of magnetic resonance imaging (MRI). MR testing of medical devices is required for device approval by the FDA and the EU notified bodies. Testing methods have been established for basic issues and were published as first ASTM International standards (formerly ASTM, the American Society of Testing and Materials). Moreover, individual safety concerns such as the safe functioning of the device and the MR system are a necessity for medical devices within an MR environment. Standardized tests increase the safety of the patient and support both the MR user and the device manufacturers. This paper describes the state of the art of MR testing methods and requirements for medical devices.

Equipment Safety↗
PubMed2005

A comparison of cardiac resynchronization by sequential biventricular pacing and left ventricular pacing to simultaneous biventricular pacing: rationale and design of the DECREASE-HF clinical trial.

BACKGROUND: The first generation of cardiac resynchronization therapy (CRT) devices approved for the treatment of heart failure used simultaneous biventricular (BiV) pacing to achieve ventricular resynchronization. Left ventricular pacing alone and sequential BiV pacing also show promise as alternative ways to deliver CRT, but have not been studied together in a large randomized trial. METHODS: The Device Evaluation of CONTAK RENEWAL 2 and EASYTRAK 2: Assessment of Safety and Effectiveness in Heart Failure (DECREASE-HF) Trial is a randomized, double-blind, 3-arm study of patients in New York Heart Association Class III or IV with an ejection fraction of 35% or less and a QRS duration > or =150 ms. Patients are randomized to receive either left ventricular pacing, simultaneous BiV pacing, or sequential BiV pacing. CONCLUSION: The study uses a novel composite endpoint that combines peak oxygen consumption and left ventricular end systolic dimension, thus combining a measure of symptomatic improvement (peak oxygen consumption) with a physiologic measure of ventricular reverse remodeling (left ventricular end systolic dimension) into a single composite score. Additionally, the safety and effectiveness of the CONTAK RENEWAL 2/4/4HE/EASYTRAK 2 system will be evaluated using: heart failure-related adverse events; system-related complications; left ventricular lead-related complications; detection time of induced ventricular fibrillation; and left ventricular lead performance (pacing threshold, pacing impedance, and R-wave amplitude).

Cardiac Output↗
PubMed2002

Devices in the treatment of epilepsy.

The goal of the treatment of epilepsy is to eliminate seizures while causing no side effects. For persons whose seizures are refractory, epilepsy surgery may be an option. In addition, these patients may benefit from the vagus nerve stimulator (VNS), the first device approved for the treatment of refractory epilepsy. Although VNS was the first to be approved, investigators have been interested in the effectiveness of stimulating other brain regions: the cerebellum, thalamus, subthalamic nucleus, and locus coeruleus are a few examples. These studies have produced mixed results. As our understanding of the underlying mechanisms of epilepsy grows, it is likely that we will design better and more effective devices for the treatment of epilepsy.

Cerebellum↗
PubMedDate not supplied

The EasyTube for airway management in emergencies.

BACKGROUND: The EasyTube (EzT) is a new sterile, disposable airway device approved by the European Union in February 2003 and by the U.S. Food and Drug Administration in January 2005. The two-lumen design of the EzT enables it to be used as an endotracheal tube or as a supraglottic emergency airway. OBJECTIVE: To report the preliminary experiences with the EzT airway device in prehospital and in-hospital emergency airway management procedures. METHODS: All airway management procedures involving the EzT were recorded for a period of 18 months. RESULTS: The EzT was successfully used to intubate 15 patients with unanticipated airway difficulties during either anesthesia induction or prehospital airway management. In all patients, the EzT was positioned successfully in the first attempt, within a median time of 31 seconds until start of ventilation. Effective supraglottic ventilation and oxygenation was achieved within 25 to 40 seconds. In three patients, the EzT needed one additional repositioning maneuver. On removal of the EzT, no blood was observed on the surface of the device, as a sign of absence of potential mucosal lesion. No injuries were observed in the mouth, pharynx, or esophagus. CONCLUSIONS: The first experiences with the use of the EzT are promising. In emergency airway management procedures presenting problems, the device successfully established sufficient ventilation and oxygenation. Further studies are needed to compare its value with those of other supraglottic devices.

Adult↗
PubMed1994

Repair of abdominal aortic aneurysm by transfemoral endovascular graft placement.

PURPOSE: The authors describe the initial clinical experience with a new device, approved by the FDA for investigation, for repair of abdominal aortic aneurysm by transfemoral endovascular insertion of an aortic graft. METHODS: Sixty-nine patients with abdominal aortic aneurysms were screened, and ten were found to be suitable for endovascular grafting. Repair was done in the operating room using general anesthesia. One femoral artery was surgically exposed, and the device, containing a premeasured graft with proximal and distal self-expanding fixation devices, was inserted with fluoroscopic control through an open arteriotomy. FINDINGS: Eight of ten patients underwent successful graft placement, and two patients required conversion to an open repair. On follow-up, six of eight patients who underwent graft placement functioned normally, with documented aneurysm thrombosis. Two patients who underwent graft placement functioned normally, with contrast computed tomography evidence of incomplete aneurysm thrombosis, but without further expansion. CONCLUSION: Transfemoral repair is safe and appears to be effective. Phase II study currently is appropriate, with need for long-term follow-up.

Aged↗
PubMed2001

Blood pumps: technologies and markets in transformation.

The heart failure industry or sector of blood pump technologies comprised of scientists, medicine, and business has inadequate attention from the financial community due to the perception of unmet market potential and regulatory hurdles. There are more than 20 mechanical circulatory support technologies currently in some stage of development. The application is defined initially for emerging technologies as bridge-to-transplant whereas more mature devices have focused on bridge-to-recovery and alternative-to-transplant. Regulatory hurdles and financing resources have dictated this initial application strategy. Whether a technology has valves, bearings, is magnetically suspended, acts as a pressure cuff, and so on, the future will belong in large part to those technologies that are less expensive, have improved ergonomics, are simpler in surgical application, and can demonstrate efficacy levels that are an improvement over today's approved devices. Today's devices have provided a valuable platform for the emerging technologies. However, there has been little market expansion over these past years, relative to the potential market. The cardiologist is the patient's gatekeeper, and drugs appear to be the therapy of choice as options are considered. Technologies without a business model will have a difficult time attracting much needed funding, the result being protracted development times or project termination. MicroMed has modified its ventricular assist device (VAD) focus, with a broader look at treating the heart failure patient. MicroMed recently entered into an agreement with Chrysalis Biotechnology, Inc., Galveston, TX, covering a synthetic peptide technology (Chrysalin) that when injected into tissue has demonstrated an angiogenic effect without the concerns inherent in recombinant angiogenic/growth factors. We believe a combination therapy of the DeBakey VAD-synthetic peptide could provide sufficient revascularization for bridge-to-recovery or as an alternative-to-transplant in certain patients.

Angiogenesis Inducing Agents↗
PubMed2000

A phase 2 study of radio frequency interstitial tissue ablation of localized renal tumors.

PURPOSE: Small renal tumors are frequently detected during the screening of patients with a hereditary type of renal cancer. The development of nonsurgical treatment modalities would greatly improve quality of life in these patients. We present our experience with radio frequency interstitial tissue ablation, a heating device approved by the Food and Drug Administration for treating soft tissue tumors. MATERIALS AND METHODS: Patients underwent radio frequency interstitial tissue ablation of small renal tumors just before surgical excision. Pathological examination of the renal tumors was done to evaluate the treatment effect. Computerized tomography and renal function testing were performed before and after therapy to evaluate toxicity. RESULTS: Four patients underwent treatment of a total of 14 tumors with the radio frequency interstitial tissue ablation device just before surgical removal of the tumors. All lesions were brown after ablation, in contrast to the normal pink appearance of untreated lesions that were resected. On color Doppler ultrasound blood flow to each tumor evident before was not visualized after treatment. The Wilcoxon rank sum test demonstrated no difference preoperatively and postoperatively in blood urea nitrogen, serum creatinine, creatinine clearance or differential renal function. We identified no toxicity associated with radio frequency interstitial tissue ablation. Of the excised tumors 11 were renal cell carcinoma and 3 fibrotic hemorrhagic cysts. For renal cell carcinoma the treatment effect involved the loss of nuclear detail and nonvisualization of nucleoli. These changes were not observed in any tumors resected without radio frequency interstitial tissue ablation. The treatment effect was noted in 10 of the 11 lesions, and in 1 case the treatment effect involved 35% of the tumor. CONCLUSIONS: No toxicity was associated with radio frequency interstitial tissue ablation. Percutaneous treatment of renal tumors is planned to evaluate the treatment effect better and further evaluate toxicity.

Adult↗
PubMed2006

Endoscopic anti-reflux devices: a year of challenges and change.

PURPOSE OF REVIEW: Endoscopic antireflux procedures have generated much interest among clinicians and patients. These devices utilize a variety of methods in an attempt to decrease reflux of gastric contents. This work reviews the most notable results of endoscopic antireflux procedure studies published in 2005. RECENT FINDINGS: A variety of studies of different technologies have been published this year. Only a few of these studies report data beyond 12 months to establish longer term efficacy. One sham controlled multicenter trial was published this year. After case reports of complications related to Enteryx (Boston Scientific Corp, Natick, Massachusetts, USA) use, this US Food and Drug Administration-approved device was voluntarily removed from the market. SUMMARY: A review of the literature demonstrates a paucity of long-term studies, as well as a lack of data comparing the devices to active medical therapy. The majority of studies are open-label trials with subjective endpoints, and such study designs are very susceptible to placebo effect. No one technology has demonstrated superiority to another. Additional studies with vigorous attention to methodology, safety evaluation, cost analysis and clinically meaningful endpoints will be required.

Endoscopes, Gastrointestinal↗
PubMed2000

Synthetic biodegradable polymers as orthopedic devices.

Polymer scientists, working closely with those in the device and medical fields, have made tremendous advances over the past 30 years in the use of synthetic materials in the body. In this article we will focus on properties of biodegradable polymers which make them ideally suited for orthopedic applications where a permanent implant is not desired. The materials with the greatest history of use are the poly(lactides) and poly(glycolides), and these will be covered in specific detail. The chemistry of the polymers, including synthesis and degradation, the tailoring of properties by proper synthetic controls such as copolymer composition, special requirements for processing and handling, and mechanisms of biodegradation will be covered. An overview of biocompatibility and approved devices of particular interest in orthopedics are also covered.

Biocompatible Materials↗
PubMed1998

PAPNET-assisted rescreening of cervical smears: cost and accuracy compared with a 100% manual rescreening strategy.

CONTEXT: The Food and Drug Administration has recently approved several devices that use computerized image analysis to rescreen Papanicolaou (Pap) smears that have already been examined by cytotechnologists. Physicians and laboratories must decide whether the utility of these devices justifies the cost. OBJECTIVE: To determine the effectiveness and cost of PAPNET-assisted rescreening in identifying cervical abnormalities not identified by manual rescreening. DESIGN: PAPNET-assisted rescreening of 5478 Pap smears obtained in 1994 and 1995 previously identified as "within normal limits" or "benign changes" on both initial and random screening. PATIENTS: Female service members and dependents aged 12 to 88 years. SETTING: Air Force clinics in the United States and Japan. INTERVENTION: Rescreening of Pap smears by PAPNET, followed by reevaluation of abnormal smears by the consensus panel, consisting of 3 cytotechnologists and 3 pathologists. MAIN OUTCOME MEASURES: Proportion of Pap smears initially screened as normal identified as abnormal by both PAPNET and consensus panel; costs of rescreening. RESULTS: PAPNET screening identified 1614 (29%) slides requiring additional microscopic review. On further review, 448 (8% of total) had possibly abnormal cells. Ultimately, 11 of these cases were reviewed by the consensus panel for potentially atypical cells. Of these 11 cases, 5 were reclassified as atypical squamous cells of undetermined significance (ASCUS) and 1 as atypical glandular cells of undetermined significance (AGUS). No additional squamous intraepithelial neoplasia (SIL) was identified in these smears; the patient with a diagnosis of AGUS on rescreening was diagnosed as having a low-grade SIL (LSIL) on follow-up. Costs were $5825 to $33781 for each additional ASCUS or AGUS diagnosis. A cost of $17475 to $101343 is expected for each case of LSIL identified by PAPNET-assisted rescreening and not by traditional manual rescreening. CONCLUSIONS: PAPNET-assisted rescreening identified a few more cases of ASCUS than did manual rescreening, but at a relatively high cost. The costs of rescreening should be carefully compared with the expected efficacy in reducing cervical cancer mortality.

Adolescent↗