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PubMed1991

Software quality regulation under the Safe Medical Devices Act of 1990: hospitals are now the canaries in the software mine.

The 1990 Medical Device Amendments to the Food and Drug Act have caused a significant change in the regulation of medical software. The 1990 Act replaces the prior emphasis on premarket approvals with an emphasis on postmarket surveillance. Hospitals and other institutional users are now required to report to the FDA product defects that cause injuries or death. They are also required to report product defects to the manufacturer. The Act provides for rapid suspensions of device approval, recalls of defective products and civil penalties for violators. The combination of these factors may lead to enhanced FDA supervision of the purchase and use of medical software, and particularly an emphasis on finding unregistered producers. In addition, the new Act will have a direct effect on the regulation of software, because it is much better suited to addressing the problem of software quality than the 1976 Act.

Equipment Safety↗
PubMed2005

Determinants of 30-day adverse events following saphenous vein graft intervention with and without a distal occlusion embolic protection device.

Distal balloon occlusion was approved as a means of embolic protection during saphenous vein graft intervention based on its ability to decrease major adverse clinical events (MACEs) by 42% in the 801-patient Saphenous Vein Graft Angioplasty Free of Emboli Randomized (SAFER) trial. However, the cost and technical complexity of this device have limited its widespread use and prompted some to avoid its use in cases that appear at "low risk" for complications. If predictors of MACEs and their potential decrease by distal balloon occlusion could be identified, this would have important clinical implications in this challenging population. We therefore used standard demographic and angiographic variables and 2 new angiographic markers (extent of graft degeneration and estimated volume of plaque in the target lesion) to construct multivariable logistic regression models of 30-day of MACEs in the SAFER trial. Independent correlates of increased 30-day MACEs were more extensive vein graft degeneration (p = 0.0001) and bulkier lesions (larger estimated plaque volume, p = 0.0005). Use of a distal balloon occlusion device was independently predictive of lower 30-day rates of MACE (p = 0.01), with uniform benefit across risk strata (no significant interaction between device use and independent angiographic risk factors). Thus, the risk of 30-day MACEs after percutaneous intervention in aortocoronary saphenous vein grafts is increased in more diffusely diseased grafts and in bulkier lesions, but a significant benefit of the GuardWire was seen across all levels of MACE risk rather than just those perceived to be at highest risk.

Aged↗
PubMed2006

Financial anatomy of neuroscience research.

OBJECTIVE: To estimate the level of funding for neuroscience research from federal and industry sources and to examine the therapeutic advances in the neurosciences over the past decade. METHODS: We examined financing for neuroscience research over the past decade from the following principal sponsors of biomedical research: the National Institutes of Health, the pharmaceutical industry, large biotechnology firms, and large medical device firms. We also examined US Food and Drug Administration approvals for new molecular entities and medical devices for indications within the neurosciences. Neuroscience was defined to include funding and approvals for neurological and psychiatric conditions. RESULTS: Total (nominal) industry and government funding for neuroscience research increased from $4.8 billion in 1995 to $14.1 billion in 2005 and doubled after adjusting for inflation. In 2005, the pharmaceutical industry and the largest biotechnology and medical device firms accounted for 58% of total funding. The US Food and Drug Administration approved 40 new molecular entities for indications within the neurosciences from 1995 to 2005, with the annual number of approvals remaining relatively stagnant during this period. From 1995 to 2005, the US Food and Drug Administration also approved 1,679 medical devices in the neurosciences for use. INTERPRETATION: Financing for neuroscience research has increased significantly over the past decade, but new approvals for drugs in the neurosciences have not kept pace with the rapid increase in funding. This lag may represent a natural delay in realizing the return in the investment in scientific research or a decline in the productivity of neuroscience research.

Animals↗
PubMed2006

Performance of a new hand-held device for exhaled nitric oxide measurement in adults and children.

BACKGROUND: Exhaled nitric oxide (NO) measurement has been shown to be a valuable tool in the management of patients with asthma. Up to now, most measurements have been done with stationary, chemiluminescence-based NO analysers, which are not suitable for the primary health care setting. A hand-held NO analyser which simplifies the measurement would be of value both in specialized and primary health care. In this study, the performance of a new electrochemical hand-held device for exhaled NO measurements (NIOX MINO) was compared with a standard stationary chemiluminescence unit (NIOX). METHODS: A total of 71 subjects (6-60 years; 36 males), both healthy controls and atopic patients with and without asthma were included. The mean of three approved exhalations (50 ml/s) in each device, and the first approved measurement in the hand-held device, were compared with regard to NO readings (Bland-Altman plots), measurement feasibility (success rate with 6 attempts) and repeatability (intrasubject SD). RESULTS: Success rate was high (> or = 84%) in both devices for both adults and children. The subjects represented a FENO range of 8-147 parts per billion (ppb). When comparing the mean of three measurements (n = 61), the median of the intrasubject difference in exhaled NO for the two devices was -1.2 ppb; thus generally the hand-held device gave slightly higher readings. The Bland-Altman plot shows that the 95% limits of agreement were -9.8 and 8.0 ppb. The intrasubject median difference between the NIOX and the first approved measurement in the NIOX MINO was -2.0 ppb, and limits of agreement were -13.2 and 10.2 ppb. The median repeatability for NIOX and NIOX MINO were 1.1 and 1.2 ppb, respectively. CONCLUSION: The hand-held device (NIOX MINO) and the stationary system (NIOX) are in clinically acceptable agreement both when the mean of three measurements and the first approved measurement (NIOX MINO) is used. The hand-held device shows good repeatability, and it can be used successfully on adults and most children. The new hand-held device will enable the introduction of exhaled NO measurements into the primary health care.

Adolescent↗
PubMed2001

The use of mechanical thrombectomy devices in the management of acute peripheral arterial occlusive disease.

A number of percutaneous mechanical thrombectomy devices are currently being used or undergoing clinical evaluation for the treatment of acute and chronic limb-threatening ischemia. Preliminary studies on the safety, efficacy, and device limitations have spurred an interest in percutaneous techniques for thrombus debulking as stand-alone therapy or an adjunct to pharmacologic thrombolysis. The devices have various mechanisms or combinations of mechanisms to optimize thrombus removal. Efficacy of thrombus removal is balanced by the propensity for vessel wall damage and distal embolization, especially for wall-contact devices (Arrow-Trerotola device and Cragg and Castañeda brushes). Initial experience in hemodialysis graft occlusion has subsequently moved on to peripheral arterial occlusions. Although the U.S. Food and Drug Administration has approved eight mechanical thrombectomy devices (MTDs) for use in thrombosed hemodialysis grafts, only the AngioJet LF140 is currently approved for use in peripheral arterial occlusive disease. Nevertheless, numerous clinical articles and abstracts have reported the "off-label" use of MTDs in the management of limb-threatening ischemia. A description of the eight MTDs and a review of the current literature on use of MTDs for acute peripheral arterial occlusive disease are provided.

Acute Disease↗
PubMedDate not supplied

Techniques for managing complications of arterial closure devices.

According to data reported by the American Heart Association, more than 5 million diagnostic and therapeutic catheterizations are performed each year in the United States. The number of catheterizations has tripled since 1979. It has been estimated that complications related to the access site result in more than 75,000 surgical procedures annually. Thus, improved management of the access site itself is essential to achieve the greater goals of improved care and reduced cost. Manual compression directly over the site of arterial puncture usually results in adequate hemostasis but has several significant drawbacks. Manual compression is uncomfortable for the patient, is fatiguing and time-consuming for staff, and necessitates several hours of costly in-hospital observation. In addition, it may be ineffective in achieving hemostasis, especially in the setting of systemic anticoagulation or following the use of large-bore devices. Based on the perceived need for an improved method of managing the arterial access site following catheterization, various vascular sealing devices have been developed. There are at least 8 (and the number is increasing) hemostatic vascular closure devices that are currently approved by the FDA for access site closure after femoral arterial catheterization. The chief advantage attributed to vascular sealing devices is accelerated access site hemostasis, even in the setting of anticoagulation, leading to earlier ambulation and hospital discharge following arterial catheterization. The most important drawbacks related to vascular sealing devices include the cost of the devices and the possibility of increased access site complications. Despite the paucity of properly designed studies supporting their use, it is estimated that over one million vascular sealing devices are used annually in the United States, a number that has increased dramatically in the past 5 years.In this review, we present a brief description of the design and function of the most widely used devices, describe the most common mechanisms of failure, and recommend strategies for management of access site complications including hemorrhage, arterial obstruction, and infection.

Aneurysm, False↗
PubMed1997

Overview of implantable cardioverter-defibrillator in reducing total mortality in the high-risk coronary patient.

The idea of an implantable cardioverter-defibrillator (ICD) was conceived in the mid- to late 1960s, and working circuits were built and tested at Sinai Hospital of Baltimore in the fall of 1969. After a number of years of preclinical testing, the device entered clinical trials at The Johns Hopkins Hospital in February, 1980, and received Food and Drug Administration (FDA) approval in 1985. The device appeared to be highly effective, but there was criticism that it had not been tested in a randomized fashion, and there was the feeling that drugs would eventually prove to be superior. In 1989, a series of randomized clinical trials were begun. One of these trials, the Multicenter Automatic Defibrillator Implantation Trial (MADIT), has concluded and the outcome has recently been published. The results are landmark in importance and lead the way towards rational treatment of serious ventricular arrhythmia patients in clinical practice.

Animals↗
PubMed2002

Endovascular repair of abdominal aortic aneurysms in women after FDA approval: results, complications, and limitations.

Women account for approximately 25% of patients with AAAs, but unfortunately, only 8-10% of patients considered candidates for endovascular treatment during prospective trials were women. We reviewed our experience with open surgical and endovascular techniques before and after the FDA approval of the Ancure and AneuRx devices to evaluate our results and the role of endovascular treatment of AAAs in women. From January 1999 to August 2000, 269 patients underwent elective repair of their AAAs at our institution. The 20-month period was divided into the 10 months before and after the FDA approval of the endovascular devices for comparison. In the initial time period, 75 patients (62 men and 13 women) underwent repair with 40% undergoing endovascular repair. In the 10 months after FDA approval, 194 patients (160 men and 34 women) underwent repair with 87% undergoing endovascular treatment. Ninety-two percent (155) of the patients undergoing endovascular repair in this period were treated with the AneuRx device. These 155 patients were divided into two groups based on gender to compare their early treatment results. The FDA approval of endovascular grafts has profoundly affected the treatment of infrarenal AAAs in the United States. Women continue to account for a small, but complex, proportion of patients treated with available endovascular devices and the results in these patients is worse than their male counterparts. Careful patient selection and meticulous operative techniques are needed to reliably treat women with available endovascular devices. Further developments are necessary to improve the current results and increase the proportion of women being safely and effectively treated with endovascular devices.

Aged↗
PubMed2006

Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval study.

BACKGROUND: Excessively high reoperation rates in breast augmentation premarket approval studies are a major concern of patients and the U.S. Food and Drug Administration. Over the past two decades, reoperation rates have remained between 13 and 20 percent at 3 years in three different premarket approval studies for three different types of implant devices, indicating that high reoperation rates are not device dependent. The hypothesis of this study was that implementing specific peer-reviewed and published processes can significantly reduce reoperation rates in a premarket approval study. METHODS: Fifty consecutive primary breast augmentation patients were enrolled in a premarket approval study for the Inamed Style 410 form stable, cohesive gel implant. All patients were treated specifically according to the premarket approval protocol. The series was monitored throughout the study by an independent clinical review organization and by a U.S. Food and Drug Administration inspection of the patient records on site at the author's practice. Specific content and processes were applied to patient management in patient education and informed consent, patient and surgeon decision-making processes, preoperative assessment and operative planning, implant selection based on individual patient tissue characteristics, surgical techniques, and postoperative care techniques. RESULTS: Follow-up was 100 percent (50 of 50 patients) at 1 year, 98 percent (49 of 50 patients) at 2 years (one patient could not be reached), and 94 percent (47 of 50 patients) at 3 years. No reoperations were performed on any patient followed at 3 years in the 50-consecutive-patient series. CONCLUSION: Implementing the peer-reviewed and published processes described in this study, no reoperations were performed in a prospective 50-consecutive-case series of primary augmentation mammaplasty patients in a premarket approval study with 94 percent follow-up at 3 years.

Adult↗
PubMed2005

Software process improvement for the medical industry.

This chapter describes a software process improvement framework, structured to ensure regulatory compliance for the software developed in medical devices. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (US requirement), and the European Commission under its Medical Device Directives (CE marking requirement) is achieved.

Device Approval↗
PubMed2002

Clinical trials in the new millennium.

Since the introduction of the randomized clinical trial (RCT) over 50 years ago, this method has become the corner stone for evaluating new pharmacologic or biologic agents with many disease areas benefiting. There are numerous examples demonstrating beneficial interventions as well as others either not beneficial or harmful. Statistical methodology for clinical trials has grown rapidly. Advances in information technology for data collection have allowed trials to be conducted around the world. Academia, industry and government have worked in partnership to conduct RCTs. Despite these many RCT achievements, the most interesting and challenging era of clinical trials lies ahead of us. With the human genome now sequenced, we face a new set of challenges to transform vast amounts of data into useful information. The post-genomics era will better identify the disease mechanism and thus help design better treatments, and be more selective in screening patients, yielding more efficient clinical trials. For some areas of medicine, such as medical devices, standards of acceptance and regulatory approval are changing. Other areas, such as medical procedures and alternative medicines, are generally not well evaluated and could benefit greatly from a wider use of RCT methodology. As the ICH guidelines facilitate and encourage international clinical trials, the scientific and ethical dimension of conducting trials in Third World countries are raised. For example, Western society's best standard of care may not be available or affordable to these countries as the control Western investigators should not exploit patients in the Third World. Those and many other challenges face us in the decade ahead. It is truly an exciting time with new opportunities for the RCT to contribute to medicine and health care or prevention.

Data Interpretation, Statistical↗
PubMed1998

Medical devices; reports of corrections and removals; lift of stay of effective date--FDA. Final rule; lift of stay of effective date.

The Food and Drug Administration (FDA) is lifting a stay of the effective date of certain provisions in a final rule on establishing procedures for submission of reports of corrections and removals of medical devices. The Office of Management and Budget (OMB) has approved the collection of information requirements contained in the final rule.

Device Approval↗
PubMed1995

Cochlear implantation in the senior citizen age group using the Nucleus 22-channel device.

Cochlear implantation has become a recognized beneficial method of assisting in the rehabilitation of the profoundly deaf individual. The only device that is currently approved by the Food and Drug Administration for implantation in children and adults in the United States is the Nucleus 22-channel device. Since 1988, the Nucleus is the only device that has been implanted at the Mayo Clinic, Rochester, Minnesota. Fifty-six patients ranging in age from 3 to 85 have received implants. Twenty-five (45%) were over 55 and 14 (25%) were 65 or older. All of the patients over 55 are currently using their implants. Several of the patients over 65 are continuing to be gainfully employed. The benefits, complications, and results are addressed.

Adolescent↗
PubMed2005

FilterWire distal embolic protection device for vein graft stenting: initial single-center experience.

BACKGROUND: Saphenous vein graft (SVG) intervention is associated with a significant incidence of major adverse cardiac events (MACE) related to distal vessel embolization. The FilterWire distal embolic protection device has recently been approved as an adjunct to SVG intervention. We report here our initial experience in a single center in 30 consecutive patients using this device in SVG stenting. HYPOTHESIS: This study examined the outcomes and complications associated with these devices, as well as whether proficiency with the devices increased with greater experience and whether there were measurable outcome differences between devices. METHODS: We retrospectively identified all patients in whom a FilterWire device was placed at our hospital between June 2001 and June 2004. RESULTS: The device was successfully deployed in 29 of 30 patients, and all patients were stented successfully. Overall MACE rate was 6.6%, consistent with reports in larger multicenter clinical trials. Transient decreases in flow were noted while the device was in place in six patients, but improved in five patients with device removal. CONCLUSIONS: This early experience in a single center using FilterWire embolic protection indicates that excellent clinical results can be obtained by the adoption of filter protection for SVG intervention, without evidence for a detrimental learning curve.

Aged↗
PubMed1999

Bridge to transplantation: the Penn State experience.

BACKGROUND: During the past decade, ventricular assist devices as a bridge to transplantation have moved from the experimental arena to accepted therapy. Our institution has been at the forefront of the development of this technology and consequently has had extensive experience with the devices that are currently approved by the Food and Drug Administration for use as a bridge to heart transplantation. METHODS: The successful management of patients with assist devices hinges on patient and device selection as well as perioperative management strategies. The routine use of agents such as aprotinin, vasopressin, milrinone, and inhaled nitric oxide has contributed to successful management of these patients. We present our perspectives on the advantages and disadvantages of the Thermo-Cardiosystems HeartMate 1000 IP device and the Thoratec (Pierce-Donachy) system. We also discuss our protocols and methods for patient selection, preoperative preparation, intraoperative strategy, and postoperative management that have resulted in improved patient outcomes. RESULTS: More than 60 device implantation procedures have been performed since the inception of our bridge to transplantation program. During this time, two thirds of our patients were successfully bridged to transplantation. Of these patients, 92% were alive at 1 month after transplantation, and 83% were alive at 1 year after transplantation. CONCLUSIONS: Both support systems are effective in supporting patients to heart transplantation. We have developed a preference for the Thermo-Cardiosystems HeartMate 1000 IP device because of its portability and associated better quality of life. However, the Thoratec device is the more versatile device, and circumstances exist when its use is clearly advantageous. In our institutional experience, outcome for bridging to transplantation has not been device dependent.

Equipment Design↗
PubMed1999

The REMATCH trial: rationale, design, and end points. Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure.

BACKGROUND: Because left ventricular assist devices have recently been approved by the Food and Drug Administration to support the circulation of patients with end-stage heart failure awaiting cardiac transplantation, these devices are increasingly being considered as a potential alternative to biologic cardiac replacement. The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial is a multicenter study supported by the National Heart, Lung, and Blood Institute to compare long-term implantation of left ventricular assist devices with optimal medical management for patients with end-stage heart failure who require, but do not qualify to receive cardiac transplantation. METHODS: We discuss the rationale for conducting REMATCH, the obstacles to designing this and other randomized surgical trials, the lessons learned in conducting the multicenter pilot study, and the features of the REMATCH study design (objectives, target population, treatments, end points, analysis, and trial organization). CONCLUSIONS: We consider what will be learned from REMATCH, expectations for expanding the use of left ventricular assist devices, and future directions for assessing clinical procedures.

Heart Failure↗
PubMed2006

Successful salvage of ventricular-assist devices in the setting of pump pocket infection.

Implantable ventricular-assist devices (VADs) have been approved for use both as a bridge to heart transplantation and as a destination therapy. Rising numbers of patients are surviving with these devices for several years. However, infections of these foreign bodies are serious and frequent complications, often requiring removal of the implant, with serious health consequences. Given the increased use of VADs as life-preserving destination therapy, explantation of these devices in the face of infection is impractical. We evaluated and successfully treated 2 patients with VAD pocket infections referred by the cardiac surgery service at our institution using aggressive surgical and pharmacologic therapy, with the goal of preserving the VADs. However, this is still a largely unsolved dilemma requiring further exploration into prevention and treatment since these devastating infections will likely become a more frequent reconstructive challenge.

Aged↗