FDA Internet Application Site (Accessdata) Error

Frequently bought together

Global Cardiovascular Surgical Devices and Technologies Market 2012 - 2020

Cardiovascular devices and companies

[GOOGLEFREETEXTUNIQ-5-7rsv symptoms in adults with asthma]

Aetna considers implantable congestive heart failure monitors e. Aetna considers an implantable wireless pulmonary artery pressure monitor CardioMems experimental and investigational for heart failure and all other indications, cardiovascular devices and companies. Aetna considers self-contained cardiovascular devices and companies monitors medically necessary for members with cardiac pacemakers. These include the following types:. A specialized telephone attachment for trans-telephonic transmission of pacemaker monitoring results is also considered medically necessary.

The Pace Trac is an example of a pacemaker monitor currently on the market. A pacemaker controls cardiac arrhythmias by repeated electrical stimulation of the heart. Pacemaker monitoring equipment is needed to detect impending battery failure and to monitor the performance of the pacemaker.

The design of the self-contained pacemaker monitor makes it possible for the member to monitor his or her pacemaker periodically and minimizes the need for regular visits to the outpatient department of the provider. Aetna considers automated oscillometer blood pressure monitors e.

Aetna considers non-invasive assessment of central blood pressure e. Aetna considers the AngelMed Guardian intracardiac ischemia monitoring device experimental and investigational because of insufficient evidence in the peer-reviewed literature. The study found that patients assigned to HTM did not have significantly fewer days dead or hospitalized the primary study endpoint than patients assigned to NTS or UC.

Home telemonitoring consisted of twice-daily patient self-measurement of weight, BP, HR, and rhythm with automated devices linked to a cardiology center. The NTS consisted of specialist nurses who were available to patients by telephone.

Primary care physicians delivered UC. The investigators reported that, during days of follow-up, there was no statistically significant difference in cardiovascular devices and companies days that were lost as the result of death or hospitalization for UC, NTS, and HTM, cardiovascular devices and companies. The number of admissions and mortality were similar among patients randomly assigned to NTS or HTM, but the mean duration of admission was less in patients assigned to HTM.

In a systematic review, Chaudhry et al examined the evidence on telemonitoring in patients with chronic heart failure. Two studies directly compared effectiveness of 2 or more forms of telemonitoring. Study quality and intervention type varied considerably. Of the 3 negative studies, 2 enrolled low-risk patients and patients with access to high quality care, whereas 1 enrolled a very high-risk Hispanic population. Studies comparing forms of telemonitoring demonstrated similar effectiveness.

The authors concluded that the evidence base for telemonitoring in heart cardiovascular devices and companies is currently quite limited. Furthermore, an editorial published in the British Medical Journal Grancelli and Ferrante, cardiovascular devices and companies, which addressed another systematic evidence review found similar results with simple telephone interventions compared to complex congestive heart cardiovascular devices and companies telemonitoring.

Dang et al evaluated the evidence base for the use of home telehealth remote monitoring in elderly with congestive heart failure CHF. The search was restricted to randomized controlled trials using either automated monitoring of signs and symptoms or automated physiologic monitoring.

For this review, telephone-based monitoring of signs and symptoms was not considered remote monitoring. Studies were also excluded if they did not present outcomes related to healthcare utilization. Two studies showed significant reduction in the number of Emergency Department visits. Available data suggest that telemonitoring is a promising strategy, cardiovascular devices and companies.

The authors stated that more data are needed to determine the ideal patient population, technology, and parameters, frequency and duration of telemonitoring, and the exact combination of case management and close monitoring that would assure consistent and improved outcomes with cost reductions in CHF. Schmidt and colleagues reviewed the current status of health services research on telemonitoring, focusing on patients with chronic CHF.

The Medline database was selectively searched for articles appearing from June to Maywith an emphasis on randomized, cardiovascular devices and companies trials. The available scientific data on vital signs monitoring are limited, yet there is evidence for a positive effect on some clinical endpoints, particularly mortality.

However, any possible improvement of patient-reported outcomes, such as the quality of life, still remains to be demonstrated. A valid criticism is that the individual components of HTM have not yet been separately tested in order to compare their individual effects.

Polisena and associates conducted a systematic review of the literature about HTM compared with usual care. Several studies suggested that HTM also helped to lower the number of hospitalizations and the use of other health services.

Patient quality of life and satisfaction with HTM were similar or better than with usual care. Koehler et al examined if physician-led remote telemedical management RTM compared with usual care would result in reduced mortality in ambulatory patients with CHF. Patients were randomly assigned 1: Remote telemedical management used portable devices for ECG, cardiovascular devices and companies, BP, and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers.

The primary end point was death from any cause. The first secondary end point was a composite of cardiovascular death and hospitalization for HF. The median follow-up was 26 months minimum 12and was Compared with usual care, RTM had no significant effect on all-cause mortality hazard ratio, 0.

The authors concluded that in ambulatory patients with CHF, cardiovascular devices and companies, RTM compared with usual care was not associated with a reduction in all-cause mortality. An assessment by the California Technology Assessment Forum Tice, found that home telemonitoring for patients with heart failure does not meet CTAF TA Criterion 3 through 5 for safety, effectiveness and improvement in health outcomes.

The cardiovascular devices and companies, patient populations, interventions, control groups, outcomes and length of follow-up varied widely between the studies. Because of the heterogeneity in the trials and their outcomes,CTAF performed no formal metaanalysis.

CTAF noted that neither study found any benefit to home monitoring compared with usual care. The CTAF assessment observed that there were not even trends in favor of home telemonitoring. The CTAF assessment noted that the strongly positive findings in some of the randomized trials suggest that there are subgroups of patients with HF who benefit from some form of telemonitoring. Kitsiou et al evaluated the methodology, quality, and reporting characteristics of prior reviews that have investigated the effects of HTM interventions in the context of chronic diseases.

Potential reviews were screened and assessed for inclusion independently by 3 reviewers. Data pertaining to the methods used were extracted from each included review and examined for accuracy by 2 reviewers. A total of 24 reviews, 9 of which were meta-analyses, were identified from more than citations, cardiovascular devices and companies.

The bibliographic search revealed that the number of published reviews has increased substantially over the years in this area and although most reviews focus on studying the effects of HTM on patients with CHF, researcher interest has extended to other chronic diseases as well, such as diabetes, hypertension, chronic obstructive pulmonary disease, and asthma. Nevertheless, an important number of these reviews appear to lack optimal scientific rigor due to intrinsic methodological issues.

Also, the overall quality of reviews did not appear to have improved over time. While several criteria were met satisfactorily by either all or nearly all reviews, such as the establishment of an a priori design with inclusion and exclusion criteria, use of electronic searches on multiple databases, and reporting of studies characteristics, there were other important areas that needed improvement.

Duplicate data extraction, manual searches of highly relevant journals, inclusion of gray and non-English literature, assessment of the methodological quality of included studies and quality of evidence were key methodological procedures that were performed infrequently. Furthermore, certain methodological limitations identified in the synthesis of study results have affected the results and conclusions of some reviews.

The authors concluded that despite the availability of methodological guidelines that can be utilized to guide the proper conduct of systematic reviews and meta-analyses and eliminate potential risks of bias, this knowledge has not yet been fully integrated in the area of HTM. Moreover, they stated that further efforts should be made to improve the design, conduct, reporting, and publication of systematic reviews and meta-analyses in this area.

Implantable hemodynamic monitoring devices have features that allow remote monitoring of hemodynamic data in patients with HF, cardiovascular devices and companies. The device consists of an implantable monitor and a transvenous lead carrying a pressure sensor, cardiovascular devices and companies. The pressure-sensing cardiovascular devices and companies continuously measures intra-cardiac pressure, body temperature, physical activity, and HR.

The Chronicle IHM has an investigational device exemption in the United States, which allows use of the device in clinical trials. For the first 6 months, all IHM patients transmitted monitoring data weekly. Physicians for the control group were blocked from receiving IHM data.

After 6 months, all physicians received IHM information for patient care. The primary end point of the study was a statistically significant reduction in treatment events, as defined by hospitalizations for HF, or emergency or urgent care center visits requiring intravenous therapy.

The class IV severe subgroup did worse than the control group. The event rate over the course of the 6 months was 0, cardiovascular devices and companies. The relative risk of HF hospitalizations was 0. Primary safety related study end points were met, including freedom from system-related complications and freedom from pressure-sensor failure. There were no pressure-sensor failures after 6 months. FDA panel concluded the trial failed to meet its primary efficacy end point. The report stated that large randomized controlled trials are needed to demonstrate the clinical utility of IHM, particularly in terms of its impact on reducing hospitalization and improving patient outcomes, cardiovascular devices and companies.

Abraham noted that HF represents a major public health concern, associated with high rates of morbidity and mortality. A particular focus of contemporary HF cardiovascular devices and companies is reduction of hospital admission and re-admission rates. While optimal medical therapy favorably impacts the natural history of the disease, devices such as cardiac resynchronization therapy devices and implantable cardioverter defibrillators have added incremental value in improving HF outcomes.

These devices also enable remote patient monitoring via device-based diagnostics. Device-based measurement of physiological parameters, such as intra-thoracic impedance and HR variability, provide a means to assess risk of worsening HF and the possibility of future hospitalization. Beyond this capability, implantable hemodynamic monitors have the potential to direct day-to-day management of HF patients to significantly reduce hospitalization rates.

Observations from a pilot study also supported the potential use of a left atrial pressure monitoring system and physician-directed patient self-management paradigm; these observations are under further investigation in the ongoing LAPTOP-HF trial. A small, paper clip-sized sensor is implanted into the effects of clindamycin and kidney damage artery during a heart catheterization procedure.

Once the device is implanted and the individual returns home, the Patient Electronics System uses wireless technology to read the PA pressure measurements and then transmits the information to the physician. Individuals purportedly may obtain a daily reading with the system and their physician can make medication adjustments based on the information received. The recipient of the device must be able to tolerate two types of anticoagulation medication for one month after the implantation procedure, cardiovascular devices and companies.

The Champion heart failure sensor is a capsule-sized 15 mm by 3 mm wireless microelectromechanical MEMS device that is permanently implanted into the pulmonary artery to monitor PAP and cardiac output Optum, The pressure-sensitive sensor consists of a coil and capacitor sealed in silicone.

Two nitinol loops anchor the hemodynamic sensor into place within the pulmonary artery branch. The battery-free sensor is powered by external radiofrequency energy from an external antenna wand.

The Champion device is delivered through the femoral vein using a preloaded Swan-Ganz catheter-based system that advances the device into the pulmonary artery. After the procedure, which takes place in a catheterization lab, patients remain in the hospital overnight for observation. Anticoagulant therapy is given for 1 month after device implantation, followed by daily aspirin therapy.

 

Cardiovascular devices and companies

.