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PubMed1997

Regulatory issues relating to therapies for periodontal regeneration.

The Food and Drug Administration (FDA) has regulated medical devices since May 1976, when the Medical Device Amendments were enacted. The clinical trial requirements for the marketing of periodontal regeneration devices have been dependent, in part, on the degree of their similarity to devices marketed prior to the legislative enactment date in terms of materials, indication statements, and labeling claims. Nonresorbable barriers were allowed to be marketed based on their equivalence to devices marketed prior to the enactment date based on biocompatability and clinical trial data under the premarket notification requirements section of the law. Bone filling materials such as hydroxyapatite were first marketed based on the finding of equivalence to predicate devices. Newer technologies such as bioabsorbable barriers have also been reviewed under the premarket notification provisions of the law, but manufacturers have been required to provide more extensive safety and effectiveness data to establish equivalence to pre-Amendments devices. Data to answer questions related to the potential toxicity of breakdown products, period of absorption, and ultimate clinical effectiveness needed to be answered prior to marketing. New devices that incorporate technologies that are not substantially equivalent to predicate devices must proceed through the premarket approval route to marketing. For new devices considered a potential significant risk to the patient population, clinical trials are conducted via the investigational device exemption (IDE) requirements that specify the means by which trials will proceed in order to protect the rights of patients. New devices of organic origin, such as bone morphogenic protein, have followed the premarket approval route with IDE requirements instituted as a condition for their path to the marketplace. Issues associated with immediate and long-term contact including potential toxicity, tumorigenicity, and sensitization need to be addressed with appropriate animal models.

Animals↗

PubMedDate not supplied

Aberration analyses needed for FDA evaluation of safety and effectiveness of wavefront-guided refractive surgical devices.

PURPOSE: Manufacturers of refractive surgical lasers are seeking Food and Drug Administration (FDA) approval for refractive surgery based on wavefront measurements rather than manifest refractions. This article draws attention to the need for better understanding of the relationship between aberrations and visual function and better testing methods for evaluating safety and effectiveness of wavefront-guided refractive surgery. METHODS: Before U.S. market approval for a new medical device, the FDA must determine whether the manufacturer has provided reasonable assurance that the device is safe and effective for its intended use, based on valid scientific evidence. The issues discussed here are based on FDA reviewers' experiences in evaluating Investigational Device Exemption (IDE) and Premarket Approval (PMA) applications for wavefront-guided refractive lasers. RESULTS: Even an optimal wavefront correction can provide only a marginally greater visual function benefit than a conventional spherocylindrical correction in a normal eye. Actual benefits are even smaller or nonexistent because variability from uncontrollable sources (eg, healing, aging, accommodation, pupil size, or ocular biomechanical effects) are typically larger than the errors treated. The effects of higher order aberrations and aberration changes on visual function are complex and poorly understood. CONCLUSIONS: The FDA's need for better tools to assess safety and effectiveness of wavefront-guided refractive surgery has stimulated major research efforts within the vision, ophthalmic, and optometric research communities. More research is needed to better understand the relationship between aberrations and visual function, and to be able to predict the visual effects of specific aberration changes in individual eyes. This research would have been more appropriately done before rather than after clinical trials for wavefront-guided refractive lasers.

Cornea↗

PubMed1998

Medical devices; 30-day notices and 135-day PMA (premarket approval application) supplement review--FDA. Direct final rule.

The Food and Drug Administration (FDA) is amending its regulations governing the submission and review of premarket approval application (PMA) supplements to allow for the submission of a 30-day notice for modifications to manufacturing procedures or methods of manufacture. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is publishing these amendments in accordance with its direct final rule procedures. Elsewhere in this tissue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedures for notice and comment to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.

Device Approval↗

PubMed2004

International carotid stenting study: protocol for a randomised clinical trial comparing carotid stenting with endarterectomy in symptomatic carotid artery stenosis.

BACKGROUND: Carotid stenting avoids general anaesthesia, cranial nerve injury and the discomforts of surgical treatment of carotid stenosis. A systematic review of the randomised trials showed no overall difference in the major risks of endovascular treatment for carotid stenosis compared with surgery, but the confidence intervals were wide and both methods carried a significant risk of stroke. The use of protection devices appears to improve the safety of endovascular treatment, but there are little randomised data available about long-term outcomes. We have therefore set up an international, multicentre, randomised, controlled, open, prospective clinical trial, namely the International Carotid Stenting Study (ICSS), also known as CAVATAS-2. The objectives of the ICSS are to compare the risks, benefits and cost-effectiveness of a treatment policy of referral for carotid stenting compared with referral for carotid endarterectomy. METHODS: Centres are required to have a team with audited expertise in carotid endarterectomy and stenting procedures, including at least one neurologist or stroke physician, a surgeon and an interventionalist. Attendance at a carotid stenting training course is required. Centres with more limited experience can join the trial as probationary centres, but stenting must then be proctored by an experienced interventionalist. Symptomatic patients are included over the age of 40 years with atherosclerotic carotid stenosis, suitable for both stenting and surgery, and are randomised in equal proportions between carotid endarterectomy and stenting. Stents and other devices are chosen for use at the discretion of the interventionalists but must be approved by the devices committee. The protocol recommends that a cerebral protection system should be used whenever the operator thinks one can be safely deployed. The combination of aspirin and clopidogrel is recommended to cover stenting procedures. Standard or eversion endarterectomy is allowed using local or general anaesthesia, shunts or patches. All patients will receive best medical care. Patients will be followed up by neurologists at 30 days after treatment, 6 months after randomisation and then annually up to 5 years after randomisation. The primary outcome measure is the difference in the long-term rate of fatal or disabling stroke in any territory between patients randomised to stenting or surgery. Secondary outcome measures include any stroke, myocardial infarction or death within 30 days of treatment, treatment- related cranial nerve palsy or haematoma. Restenosis (>70%) on ultrasound follow-up, economic measures and quality of life will also be analysed. The sample size is estimated at 1,500 patients, which will provide 95% confidence intervals of +/- 3.0 percentage points for the outcome measure of 30-day disabling stroke and death rate and +/- 3.3 percentage points for the outcome measure of death or stroke during follow-up. The trial office monitors outcome events at individual centres and a rate of events above a given threshold triggers a blinded assessment of the events, submitted to the chairman of the data-monitoring committee. CONCLUSIONS: The ICSS protocol incorporates a number of novel features to ensure patient safety, including the concept of probationary centres, proctoring of inexperienced investigators and monitoring of individual centre results on an ongoing basis. The protocol is also designed to mirror routine clinical practice as far as possible, so that the results will be widely applicable and relevant to determining the place of carotid stenting in clinical practice in the future.

Carotid Stenosis↗

PubMed1995

Medicare program; criteria and procedures for extending coverage to certain devices and related services--HCFA. Final rule with comment period.

This final rule establishes in regulations that certain devices with an investigational device exemption (IDE) approved by the Food and Drug Administration (FDA) and certain services related to those devices may be covered under Medicare. Specifically, it sets forth the process by which the FDA will assist HCFA in identifying non-experimental investigational devices that are potentially covered under Medicare. This rule responds to the mandate that Federal agencies streamline their regulatory processes to make them less burdensome and more customer-focused. It is intended to provide Medicare beneficiaries with greater access to advances in medical technology and encourage clinical researchers to conduct high quality studies of newer technologies.

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

PubMedDate not supplied

Lumbar spine arthroplasty using the ProDisc II.

The ProDisc was developed by Thierry Marnay, a French orthopedic surgeon, in the late 1980s. Marnay and his associate implanted ProDiscs into 64 patients from 1990 to 1993. Demonstrating remarkable intellectual restraint, he let this cohort of patients "incubate" so he could see their progress before performing any additional implantations. In 1998, 61 of these patients were still alive, and 58 (95%) of them were available for a thorough follow-up evaluation. No device-related safety issues were identified during this review, and 93% of these patients were satisfied with their implants. This unique and strong data set led to an unusually rapid Food and Drug Administration (FDA) approval for an Investigational Device Exemption study in the United States, prospectively comparing implantation of a ProDisc with a 360-degree fusion, with both single- and double-level study arms. This article represents data on the first 78 patients with at least 6-month follow-up, with 54 of these patients also having 1-year follow-up, enrolled in a prospective randomized FDA study evaluating the safety and efficacy of ProDisc II versus control, a 360-degree lumbar spinal fusion. Data were collected preoperatively at 6 weeks, 3 months, 6 months and 1 year postoperatively. Visual analog scale (VAS), Oswestry Low Back Pain Disability Questionnaire (ODQ) and patient satisfaction rates were evaluated at these intervals, as well as range of motion, return to work, recreational status and ambulatory status. At 6-month follow-up, there were there were 55 ProDisc patients and 23 who underwent fusion. Twenty-five of these patients had two-level surgery. Estimated blood loss (ProDisc, 103 cc, vs fusion, 213 cc) and operative time (ProDisc, 90 minutes, vs fusion, 232 minutes) were significantly different (p< .01). Hospital stays were shorter (ProDisc, 2.24 days, vs fusion, 3.26 days [p< .01]) for ProDisc patients. There was a significant reduction in the ODQ scores from preoperative values in both ProDisc and fusion groups. Similarly, there was a significant reduction for both groups in VAS scores from before to after surgery. A trend was identified at 6 months in patient satisfaction rates favoring ProDisc versus fusion (p= .08), which became more pronounced (although still not statistically significant) at 1 year. Flexion and lateral bend range of motion was significantly improved in ProDisc patients compared with the fusion group (p= .02). Ambulatory status as well as recreational activity improved faster in the ProDisc group. The data suggest that total disc arthroplasty may be an attractive option to lumbar fusion for the surgical treatment of disabling mechanical low back pain secondary to lumbar disc disease.

Adult↗

PubMed1995

The medical device payment controversy rages on.

Who will pay for investigational research? This seemingly endless debate assumes different guises as different aspects of the health care industry come under scrutiny. The latest wrinkle in the debate involves reimbursement for devices that are not FDA approved. My September column discussed the issue of funding investigational cancer therapies, specifically high-dose therapy and bone marrow transplant, as treatments for various malignancies. That controversy was centered on the use of FDA-approved drugs in settings beyond the labeled indications. However, the issue with medical devices is different. It involves implantable devices that the FDA says have not proven to be safe and effective.

Device Approval↗

PubMed1982

The financing and regulation of medical devices in the United States.

This paper focuses on two major areas of US federal policy that relate to medical devices, regulations regarding premarketing approval and arrangements for financing the use of devices. Other relevant areas, such as patents, liability, and taxation, are discussed more briefly. In 1976 legislation authorized the federal Food and Drug Administration (FDA) to require manufacturers of medical devices to show that their products meet acceptable levels of safety and effectiveness. FDA has classified each device into one of three classes according to the extent of regulation needed to ensure safety and effectiveness. Although all devices must conform to general manufacturing controls and some to premarketing approval, no performance standards have yet been developed. About two-thirds of all expenditures for medical care in the United States are paid by private or public insurers. Although procedures vary for institutional and individual providers, payment is usually made after the medical care has been provided and covers the provider's costs or charges. Prevailing insurance coverage and payment methods contain incentives for the innovation and use of medical devices that are part of mainstream medical care. At the same time, these financial arrangements discourage preventive and rehabilitative devices, which are generally excluded from insurance coverage.

Cost Control↗

PubMed2003

A critical review of endoscopic therapy for gastroesophageal reflux disease.

The US Food and Drug Administration has approved 2 endoscopic devices for treating gastroesophageal reflux disease, and several thousand procedures have been performed to date. At least 6 other endoscopic devices designed to treat gastroesophageal reflux are in various stages of testing and may soon obtain approval for clinical use. Short-term follow-up studies uniformly report improvement in heartburn symptoms and quality-of-life scores, as well as decreases in use of antisecretory medications. However, esophageal acid reflux is not normalized after these treatments, nor is esophagitis improved. Although troubling efficacy and safety issues are currently unresolved, these techniques are becoming routine clinical procedures outside of clinical trials. Unless there is rigorous attention to scientific validation of these techniques, including comparative trials versus conventional treatments, there will remain a cloud of doubt and concern about their role and usefulness in clinical medicine. The rapid incursion of these devices into the clinical marketplace before they have undergone critical scientific scrutiny magnifies the urgency of addressing these issues.

Cost-Benefit Analysis↗

PubMed1995

Food and Drug Administration requirements for dental implants.

The Food and Drug Administration (FDA) is a section of the Department of Health and Human Services of the United States Government, and its primary responsibility is to control the distribution of food, drugs, and medical devices within the country while ensuring public safety. The sale and distribution of dental implants is under the regulatory control of the FDA. Device classification, procedures for approval, and the current status of the approval process for endosseous implants are described in this article. The premarket approval procedure of the FDA is compared with the American Dental Association certification process. Issues related to the safety and effectiveness of dental implants are discussed.

American Dental Association↗

PubMed2006

Technology Insight: current status of video capsule endoscopy.

Video capsule endoscopy (VCE) is the most recent major practical and conceptual development in the field of endoscopy. The video capsule endoscope-a small, pill-sized, passive imaging device-has been demonstrated to be the pre-eminent imaging device for disorders of the small intestine. The initial use for VCE was to detect the origin of obscure gastrointestinal bleeding. Several other indications have now been justified, or are in the process of evaluation. More than 200,000 of these disposable devices have been used worldwide, with an extraordinarily good safety record: indeed, the device has been approved for use in children as young as 10 years of age. In addition, a double-ended capsule has now been approved for the evaluation of mucosal disease in the esophagus. The now-widespread deployment of the device into gastrointestinal practice in the US and many other countries suggests that VCE has achieved mainstream utility. The development of similar competitor devices, and devices whose movement can be controlled, is in progress.

Endoscopy, Gastrointestinal↗

PubMed2006

Making sense of the food and drug administration.

An examination of and recommendations regarding the approval process for medical devices are presented. The typical pathways and hurdles laid out by the Federal Food and Drug Administration (FDA) are discussed, and options for marketing and use of medical devices are addressed. The first step in the regulatory process is to establish that the new product is, in fact, a medical device. From there, the appropriate classification and the corresponding level of regulatory control that will be required can be identified. The appropriate marketing application will be submitted and is supported by the data necessary to reasonably assure safety and effectiveness. Once the application is submitted, reviewed, and eventually approved, the manufacturer may legally market and sell the medical device. The active involvement of physicians as advisors and innovators in medical device development is imperative to the successful development of safe and effective medical devices. Physicians also fulfill the important obligation of adverse event reporting with all medical devices that they use. The pediatric physician should additionally be aware of the FDA regulations and expectations with respect to devices that will serve pediatric patient populations, of the regulatory options for approval and unapproved use for some devices, and of the special measures taken to protect the rights, safety, and welfare of pediatric patients participating in investigational studies.

Altruism↗

PubMed2003

Endovascular management of abdominal aortic aneurysms.

An estimated 1.5 million people in the United States have abdominal aortic aneurysms (AAAs) with more than 200000 American diagnosed each year. The natural history of AAAs is to expand and rupture, accounting for an estimated 15000 deaths per year. Thus, the major impetus for AAA repair is for prophylaxis against aneurysm-related death. The standard open surgical repair of AAAs is a well-established and durable procedure. However, as with all other major abdominal surgical operations, associated significant morbidity and mortality exist, along with prolonged recovery and various late complications. Furthermore, both mortality and morbidity increase significantly with advanced patient age and associated co-morbid disease states. Endovascular AAA repair using covered stent-grafts offers a significantly less invasive alternative to conventional open-surgical repair. A considerable reduction in hospital stay has been demonstrated, with early return to preoperative levels of activity. Patients previously considered unsuitable for open repair can often receive treatment for aneurysms with endovascular techniques. Current estimates are that more than 1/2 all infrarenal AAAs will be repaired using endovascular approach in the future. Despite the minimally-invasiveness of this new treatment, there are unanswered questions as to the durability and efficacy of devices, which results in concerns about their ability to successfully protect the patient from subsequent rupture. Three devices are commercially available and have been extensively used for implantation in the United States with a 4th device recently receiving approval from the Food and Drug Administration (FDA). In this review article, endovascular management of AAAs with these devices is described, as are the design and deployment techniques of the currently available endografts.

Aortic Aneurysm, Abdominal↗

PubMed2003

Specification of acoustic output level and measurement uncertainty in ultrasonic exposimetry.

This manuscript was written to bring together the pertinent statistical procedures for specifying acoustic output values and measurement uncertainties of ultrasound devices, and to present them in a way that would be clear and convenient to the reader. Implementations of these procedures are illustrated in several examples: measurement of ultrasonic power of a single transducer, measurement of the power output of a transducer model, and measurement of the power output of an ultrasound scanner series. This manuscript is intended to be helpful to ultrasound device manufacturers who need to specify these quantities when applying for Food and Drug Administration (FDA) approval to market their new devices. It also is intended to be helpful to ultrasound users who need to interpret these values in order to meaningfully evaluate the relative risks and benefits of performing ultrasound examinations on their patients.

Device Approval↗

PubMed2004

Use of the Laryngeal Tube in two unexpected difficult airway situations: lingual tonsillar hyperplasia and morbid obesity.

PURPOSE: The 2003 ASA Practice Guidelines for Management of the Difficult Airway suggest the early use of the Laryngeal Mask Airway and Combitube as rescue airway devices in the cannot ventilate-cannot intubate situation, switching the focus from laryngoscopy and intubation to ventilation and oxygenation. The Practice Guidelines are not intended as standards but as recommendations. Multiple new alternative airway devices were described in the last ten years. The Laryngeal Tube (LT) is a new Food and Drug Administration approved supraglottic airway device. The device is in use in Europe since 1999 and in the United States since 2002. CLINICAL FEATURES: We report two cases in which the LT was used to solve two unexpected difficult airway situations. The first case ("cannot intubate-inadequate mask ventilation") involved an undiagnosed lingual tonsillar hyperplasia and the LT provided the means to ventilate and administer the anesthetic. In the second case ("cannot ventilate-cannot intubate") we report the successful use of the LT to rescue the airway in a morbidly obese patient. In both cases an endotracheal tube was ultimately inserted using an awake fibreoptic technique with the patient in the sitting position. CONCLUSIONS: In these clinical situations of unexpected difficult airway with significant periglottic obstruction the LT provided adequate ventilation after the first insertion. The LT may complement the laryngeal mask airway in difficult airway management. Further research is needed to define the role of the LT in the management of difficult airways.

Aged↗

PubMed1998

Endovascular embolization of 150 basilar tip aneurysms with Guglielmi detachable coils: results of the Food and Drug Administration multicenter clinical trial.

OBJECT: To assess the safety and efficacy of aneurysm embolization performed using Guglielmi detachable coils (GDCs), the authors reviewed the results of a cohort of 150 patients with either ruptured (83 patients) or unruptured (67 patients) basilar tip aneurysms treated with these detachable platinum coil devices in the early part of the United States multicenter GDC clinical trial that led to Food and Drug Administration approval for the device. METHODS: The most common presentation in this cohort of patients was headache (53%). All patients were entered into the trial after neurosurgical assessment excluded them as candidates for surgical clipping of their aneurysms. Greater than 90% coil packing was achieved in 75% of the patients. For those patients in whom follow-up information was available, the mean angiographic and clinical evaluation follow-up time for 61 patients with ruptured aneurysms was 13.7 months (range 0-43 months) and that for the 49 patients with unruptured aneurysms was 9.8 (range 0-40 months). Conservative mortality rates included up to 23% for the ruptured aneurysm group and up to 12% for the unruptured aneurysm group; the rebleeding rate for treated ruptured aneurysms was up to 3.3% and the bleeding rate for unruptured aneurysms up to 4.1%. Permanent deficits due to stroke in patients with ruptured or unruptured aneurysms occurred in up to 5% and 9%, respectively. Vasospasm occurred in 8% of the patients; it was associated with two deaths. Periprocedural mortality was 2.7% (four patients with ruptured aneurysms). CONCLUSIONS: Detachable platinum coil embolization is a promising treatment for ruptured basilar tip aneurysms that are not surgically clippable; in selected patients it offers lower incidences of morbidity and mortality compared with conservative medical management. The role of this procedure in unruptured basilar tip aneurysms is unclear with less supportive results. More long-term follow-up evaluation is necessary and results are expected to improve.

Adult↗

PubMedDate not supplied

Payment for using new technologies. Why it's hard to find the essential information that you need.

As methods of paying for care grow in complexity, estimating a new technology's potential for generation of revenue becomes more difficult. Among the important factors are the inpatient DRG that is assigned, the device's FDA approval status, and whether Medicare and other third parties will pay the physician fee that is often involved with the device's use. Finding precise information about some of these factors is difficult; hospital associations could help by seeking improvements in the ways in which payment decisions are made.

Diagnosis-Related Groups↗

PubMed2005

Drug/device combinations for local drug therapies and infection prophylaxis.

Combination devices-those comprising drug releasing components together with functional prosthetic implants-represent a versatile, emerging clinical technology promising to provide functional improvements to implant devices in several classes. Landmark antimicrobial catheters and the drug-eluting stent have heralded the entrance, and significantly, routes to FDA approval, for these devices into clinical practice. This review describes recent strategies creating implantable combination devices. Most prominent are new combination devices representing current orthopedic and cardiovascular implants with new added capabilities from on-board or directly associated drug delivery systems are now under development. Wound coverings and implantable sensors will also benefit from this combination enhancement. Infection mitigation, a common problem with implantable devices, is a current primary focus. On-going progress in cell-based therapeutics, progenitor cell exploitation, growth factor delivery and advanced formulation strategies will provide a more general and versatile basis for advanced combination device strategies. These seek to improve tissue-device integration and functional tissue regeneration. Future combination devices might best be completely re-designed de novo to deliver multiple bioactive agents over several spatial and temporal scales to enhance prosthetic device function, instead of the current 'add-on' approach to existing implant device designs never originally intending to function in tandem with drug delivery systems.

Animals↗