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PubMed1983

Patient-controlled analgesia.

Patient-controlled analgesia is a relatively new and investigational technique that permits patients to treat pain by directly activating doses of intravenous narcotics. The technique was developed in response to the undertreatment of pain in hospitalized patients. Continuous narcotic infusion and intraspinal narcotic administrations also have the potential to provide continuous, uninterrupted analgesia, but do not allow simple dose attentuation to avoid overdosage. Patient-controlled analgesia is used to treat postoperative and labor pain and pain associated with terminal illness; it delivers analgesic more effectively with fewer side effects than conventional parenteral narcotic therapies. The technique is also an ideal investigative instrument for studying equianalgesic states. Several foreign-made devices are now being used under investigational sanctions in this country, and it is anticipated that several American manufacturers will be seeking regulatory approval to market the devices.

Administration, Oral↗
PubMedDate not supplied

Transcatheter closure of secundum atrial septal defect using the Amplatzer Septal Occluder: initial results of a single medical center in Taiwan.

The Amplatzer Septal Occluder (ASO) is the first and only device to receive full approval for clinical use in patients with secundum atrial septal defect (ASD) from the United States Food and Drug Administration. This study reports the device's initial results in Taichung Veterans General Hospital, a tertiary medical center in central Taiwan. Between October 2001 and December 2004, 39 consecutive patients (31 females, 8 males) with secundum ASD underwent attempt at transcatheter closure using the ASO under general anesthesia and transesophageal echocardiographic guidance. Six patients were excluded due to deficient rims (2 patients), multiple ASDs (1 patient), too large a defect (1 patient), too small a defect (1 patient) and 1 patient with associated atrial flutter. A total of 33 patients (26 females, 7 males) underwent the device closure procedure. The median age was 10.6 years (range 3.1-57.5 years) and median weight was 42 kg (range 13.5-73 kg). The median Qp/Qs ratio was 2.12 (range 1.02-5.52). The median balloon stretched diameter of the defect by sizing plate was 16 mm (range 5-37 mm). A total of 33 devices (median size 17 mm, range 7-38 mm) were implanted in 33 patients. The median fluoroscopy time was 10.1 minutes (range 5.9-29 minutes) and the median procedure time was 55 minutes (range 30-105 minutes). Complications included asymptomatic device embolization to the right ventricle in 1 patient (surgical removal) and transient complete atrioventricular block in 1 patient. Follow-up echocardiography at 10 minutes, 24 hours, 1 month, 6 months, 1 year and 2 years after the procedure showed complete closure rates of 76% (25/33), 91% (30/33), 100% (32/32), 100% (22/22), 100% (22/22), and 100% (9/9), respectively. In conclusion, transcatheter closure of secundum ASD using the Amplatzer Septal Occluder is safe and effective, with a very low complication rate.

Adolescent↗
PubMed1994

FDA's requirements for in-vitro performance data for prosthetic heart valves.

The Center for Devices and Radiological Health, Food and Drug Administration, has recently revised its "Replacement Heart Valve Guidance". That document lists the data FDA deems necessary to support the approval of new prosthetic heart valves of all designs, and which should be contained in Premarket Approval Applications for these devices. The Guidance covers detailed data requirements for in vitro, animal, and clinical data. This paper is intended to briefly summarize FDA's requirements for in vitro data, and, for those cases where it may not be obvious, to provide an overview of the significance of these data and how FDA interprets them in the approval decision process.

Biomechanical Phenomena↗
PubMed2003

Cardiac resynchronization therapy devices: patient management and follow-up strategies.

Results of numerous clinical trials support the use of cardiac resynchronization therapy (CRT) for treatment of moderate to severe heart failure in patients with cardiac dyssynchrony. Commercial approval of various CRT devices has led to a growing number of patients receiving this form of therapy. Patients with implanted CRT devices require specific attention to detect adverse events related to the device, detect failure to respond to therapy, and optimize device function. Interaction between the primary care physician, cardiologist, heart failure specialist, and electrophysiologist/implanting physician is necessary to accomplish these goals. Recognizing the signs and symptoms of adverse events or suboptimal response allows the primary care physician to alter drug therapy or, when appropriate, refer the patient to the heart failure specialist or electrophysiologist for optimization of CRT device programming or further intervention.

Cardiac Pacing, Artificial↗
PubMed1999

Mechanical circulatory support with the Novacor LVAS: world-wide clinical results.

The Novacor left-ventricular assist system (LVAS) is an implantable, electrically powered device that is presently approved both in Europe and in the United States for temporary use as a bridge to cardiac transplantation in patients with advanced heart failure. The device has undergone significant evolution since its first implantation in 1984. This device provides a safe, and effective "bridge" to transplantation in select candidates. The world-wide experience as well as the experience at the University of Pittsburgh Health System with this device are discussed in this paper. The exciting results provide ample evidence for the potential use of this device as an "alternative" to transplantation, or "alternative" to medical therapy in the near future.

Clinical Trials as Topic↗
PubMed1989

Toxicology of medical device material.

The 1976 amendments to the Food, Drug, and Cosmetic Act established requirements for obtaining approval to market new medical devices, including the necessity for demonstrating safety and effectiveness. Evaluation of the potential toxicity of medical devices presents toxicologists with unique problems related to route of exposure, estimation of exposure dose, exposure to by-products generated during manufacture, and matrix effects. A symposium was organized to address the need for toxicologists to examine the potential toxicities of medical device materials, to appreciate the unique problems associated with medical device safety evaluation, to present novel testing methodologies, and to discuss future research needs.

Animals↗
PubMed1999

Surgical complications from hemostatic puncture closure devices.

BACKGROUND: For securing immediate hemostasis following percutaneous arterial catheterization, the Food and Drug Administration has approved three hemostatic puncture closure devices. We reviewed our institutional experience with one device (Angio-Seal). METHODS: A retrospective, single-center, nonrandomized observational study was made of all vascular complications following femoral cardiac catheterization. RESULTS: An immediate mechanical failure of the device was experienced in 34 (8%) patients. Surgical repair was required in 1.6% (7 of 425) of patients following Angio-Seal versus 0.3% (5 of 1662) following routine manual compression (P = 0.004). In 5 patients, the device caused either complete occlusion or stenosis of the femoral artery. The polymer anchor embolized in 1 patient and was retrieved with a balloon catheter at surgery. CONCLUSION: During the first year of utilization of a percutaneous hemostatic closure device following cardiac catheterization, we observed a marked increase in arterial occlusive complications requiring surgical repair. Surgeons must be familiar with the design of these devices to achieve precise repair of surgical complications.

Arterial Occlusive Diseases↗
PubMed2002

Mechanical strength and wear of used EBI external fixators.

Thirty-one EBI external fixators (Dynafix; EBI, Parsippany, NJ) subjected to one or two clinical uses underwent static mechanical testing identical to that performed on new devices prior to market approval. No fixator exhibited catastrophic mechanical failure. For all fixators tested, the mean load to failure was not significantly different from that of identical testing of new devices. Although loss of material from serrated joints was observed in some joints, mechanical strength was not affected. Additional testing of fixators of a variety of designs is necessary to expand on the results of this investigation. The results of this study represent a first step in validating the safety of external fixator component reuse.

Equipment Failure↗
PubMed2002

Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC).

In 1996 the Japanese Diet amended the Pharmaceutical Affairs Law (PAL) and its related laws based on 1996 report of the ad-hoc Committee for Drug Safety Ensuring Measures. Between 1996 and 2000, the drug approval system in Japan underwent a series of radical reforms. We describe in this paper the current system for drug approval, discuss the post-approval reexamination and reevaluation system, conditions under which development and review may be expedited, and mechanisms for approval of off-label usage. Finally, we discuss the impact of the International Conference on Harmonization (ICH) agreement on drug development and review in Japan.

Antineoplastic Agents↗
PubMed2005

Cardiac resynchronization devices: the Food and Drug Administration's regulatory considerations.

Cardiac resynchronization therapy (CRT) devices have been studied clinically since 1998, and have been on the U.S. market since the Food and Drug Administration (FDA) approval of the first product in 2001. Since that time, the FDA has approved many different models from three different manufacturers, representing the first and second generations of these products. All of these products have undergone the FDA pre-market approval process, which examines the safety and effectiveness of the devices for their intended use. Over the last several years, the FDA has adapted recommendations for CRT clinical trials based on an evolving understanding of what these devices can achieve. This paper will outline the dynamic nature of the FDA's approval process for CRT devices and briefly review the clinical trial designs for the first generation devices.

Biomedical Technology↗
PubMed2001

Deep brain stimulation for chronic pain: results of two multicenter trials and a structured review.

OBJECTIVES: A U.S. Food and Drug Administration ruling required clinical trials to evaluate the safety and efficacy of deep brain stimulation devices, thereby limiting treatment to the investigational setting. INTRODUCTION: As an investigator in two clinical trials of deep brain stimulation, I sought to determine why pain remained an unapproved indication despite regulatory approval of the same device for tremor. METHODS: The results of two multicenter trials of deep brain stimulation for pain were analyzed, and the pertinent literature was reviewed using published guidelines for the evaluation of clinical trial reports. RESULTS: The first-generation Model 3380 lead trial enrolled 196 patients; the current Model 3387 trial enrolled 50 patients. Prospectively defined criteria for success included at least half of patients reporting >/=50% pain relief at 1 year. Manufacture of the Model 3380 lead was discontinued, and the 3387 trial closed early because of slow enrollment, high attrition, and low efficacy. When results were analyzed according to the study plan, neither trial was successful. Consequently, deep brain stimulation has not been approved for pain control by the U.S. Food and Drug Administration. CONCLUSIONS: Deep brain stimulation has not been shown to produce effective long-term pain relief. Future studies of motor cortex stimulation and similar therapies will require appropriate control groups and accepted methods of data collection and analysis to support claims that predictable and reliable analgesic effects are produced in humans.

Journal Article↗
PubMed1994

Regulation of drugs and devices: an evolution.

The U.S. Food and Drug Administration's (FDA's) drug approval process has evolved from a system in which a drug could lawfully be marketed unless the FDA were able to prove that the manufacturer knew that the drug would not work for the conditions for which it was promoted to one in which drug-makers require advance approval from the agency for almost every important step in testing, production, and marketing. The more modern system for regulating medical devices is the product of amendments to the federal Food, Drug, and Cosmetic Act in 1976. In those amendments, Congress sought to create a framework for control of device technology that would also facilitate innovation. This paper suggests that, notwithstanding this aspiration, both external pressures and internal practices are inexorably bringing device regulation closer to the "drug model."

Device Approval↗
PubMedDate not supplied

Implantable left ventricular assist devices: new hope for patients with end-stage heart failure.

INTRODUCTION: Recently, the Food and Drug Administration approved implantable left ventricular assist devices (LVAD) as destination therapy (DT) for end-stage heart failure patients who are ineligible for cardiac transplantation. OBJECTIVE AND STUDY DESIGN: This is a case series that describes the early results with DT LVAD at Duke University Medical Center (DUMC). An additional objective is to provide general information to a broad group of caregivers on this LVAD therapy, which is a new and developing treatment option. DATA SOURCE/COLLECTION METHODS: Pretreatment clinical condition and outcomes data were collected retrospectively on this cohort of patients through chart review. Outcomes in our patients are compared to data from prior studies and established databases. PRINCIPAL FINDINGS: Since approval of this therapy two years ago, 18 patients have been treated with implantable LVAD as DT at DUMC. The primary reason for ineligibility for transplant was advanced age (median age was 66). Nearly all of the patients (89%) were confined to the hospital requiring continuous inotropic infusions or temporary mechanical support (e.g., intra-aortic balloon pump) prior to LVAD. The 30-day survival following LVAD implantation was 94.5%; one-year survival was 60%. Eighty-nine percent of patients were successfully discharged to independent living. Operative mortality is similar to that of other cardiac surgery procedures performed on patients with advanced heart failure, while duration of intensive care stay and hospitalization remain considerably longer. PRINCIPAL LIMITATIONS: The principal limitation of this review is the absence of a control group of patients with end-stage heart failure who received conventional therapies. For this reason, the DT LVAD outcomes are compared to prior studies and database results. CONCLUSION: Implantable LVAD therapy provides new hope for end-stage heart failure patients who do not qualify for cardiac transplantation.

Adult↗
PubMed1991

New technologies for the treatment of obstructive arterial disease.

The well-known limitations of balloon angioplasty include unpredictable abrupt closure, chronic total occlusion, diffuse disease, and restenosis, among other factors. These limitations have prompted the development of new technologic approaches to angioplasty including laser applications for plaque ablation, mechanical device applications for plaque removal/debridement, and stent devices for structural maintenance of vascular lumen patency. Devices which directly apply laser energy for ablation of plaque material include a balloon-centered laser angioplasty system, excimer laser ablation catheter systems, and a fluorescence-guided spectral feedback laser system. Experience with these devices indicates that plaque can be successfully ablated by using laser energy. Vessel perforation and dissection are complications reported with these devices and the effects of laser angioplasty on restenosis remain unclear. Indirect application of laser energy has been tested by using a "hot tip" catheter and a laser balloon angioplasty system. Although the hot tip device has received FDA approval for use in peripheral arteries, it appears to have very limited applications in the coronary arteries. Laser balloon angioplasty appears to be beneficial in the setting of threatened acute closure; the device continues to be evaluated for potential beneficial impact on restenosis. Mechanical atherectomy catheters are designed to remove atherosclerotic plaque from the arterial system and include the AtheroCath, the Transluminal Extraction Catheter (TEC), and the Pullback Atherectomy Catheter (PAC). The Rotablator is an atheroablation device which debrides the obstructing plaque material with distal embolization of the particulate debris. Successful removal/debridement of atherosclerotic plaque has been demonstrated with the AtheroCath, Rotablator, and the TEC device. Pre-clinical studies demonstrate successful removal of plaque material with the PAC device. Despite the theoretic advantage of removing plaque material when performing angioplasty with these devices, there has been little or no reduction in restenosis rates based on a significant experience with the AtheroCath and the Rotablator. Intravascular stent devices including one self-expanding device design and two balloon-expandable device designs have been employed successfully in the elective setting to treat recurrent restenosis lesions. Two of the devices have been successfully tested in the setting of threatened acute closure. Early follow-up studies suggest some improvement in restenosis rates in certain clinical settings following intravascular stenting. Acute and subacute thrombosis remain substantial problems for stent devices and very aggressive anticoagulation regimens are necessary to minimize the adverse events. In summary, a number of a new technologic approaches for treatment of atherosclerotic lesions have been developed and are undergoing significant clinical evaluation.(ABSTRACT TRUNCATED AT 400 WORDS)

Angioplasty, Laser↗
PubMed2002

Medical device technology user fees.

The introduction of user fees for premarket approval applications and 510(k)s will put additional thrust into the revolution in new products. AdvaMed explains why the fees are important.

Device Approval↗
PubMed1997

Surgical procedures and devices should be evaluated in the same way as medical therapy.

This paper is a personal essay that starts and ends with the message that surgical procedures and devices should be evaluated in the same way as medical therapies, namely, by randomized clinical trials (RCTs). I discuss, with particular attention to surgical procedures and devices, the objections raised against RCTs in medical decision-making, a schema for utilizing the traditional phases of RCTs in the evaluation of surgical procedures and devices, the importance of RCTs to FDA approval, financial compensation, and health care costs, the impact of RCTs on clinical practice, the role of RCTs in academia, teaching, and research, and the surgeon's obligation to participate in a leadership role in RCTs. The belief is expressed that national funding of health care should mandate allocations for RCTs and that such expenditures, as well as the spending of health care dollars on the basis of the outcomes of such trials, will not only improve patient management in the shortest time but will eventually reduce health care costs. The RCT, by selecting effective and safe surgical procedures and devices, as well as diets and drugs, is the best means science has to assess the validity of patient management.

Attitude of Health Personnel↗
PubMed1984

Success with penile prosthesis from patient's viewpoint.

This study is designed to explore the patient's point of view on success with penile prosthesis. Detailed questionnaires were sent to 57 penile prosthesis recipients, 38 of whom responded. Overall, 89 per cent claimed improved sexual satisfaction, and 76 per cent noted improved self-image with their prostheses. Seventy-six per cent claimed their partners approved of the prosthetic device. Prosthetic appearance was satisfactory to 87 per cent. Five patients, knowing what they now know, would not have had the prosthetic implantation. A significant factor in 4 of the 5 patients was lack of partner approval. We conclude penile prosthesis implantation is successful in returning satisfactory sexual intercourse to impotent men and their partners. Partners of those desiring penile prosthesis should be included in the preoperative evaluation process.

Consumer Behavior↗
PubMed2003

A prospective duplex Doppler ultrasonographic study in women with sexual arousal disorder to objectively assess genital engorgement induced by EROS therapy.

The EROS therapy device is FDA-approved for the treatment of women with sexual dysfunction and has been shown to improve sexual function and satisfaction. The aim of this study was to obtain objective information regarding the ability of the EROS Therapy device to induce clitoral and corpus spongiosum volumetric and hemodynamic changes following therapeutic use in women with sexual arousal disorder. Seven patients with sexual arousal disorder formed the study population. All seven subjects met inclusion and exclusion criteria, including having normal hormonal values at the time of the study. All seven subjects were able to comfortably operate the device. All seven reported either slight-to-moderate pleasure or orgasm at home with the device. We observed no adverse events. This study shows that EROS therapy is associated with significant increases in clitoral and corpus spongiosum diameter as well as with clitoral and corpus spongiosum peak systolic and end-diastolic velocity values.

Adult↗