Avinger Inc. recently announced positive two-year clinical data from the pivotal VISION study of the company’s Lumivascular technology. The VISION study was designed to evaluate the safety and effectiveness of Avinger’s Pantheris system to perform directional atherectomy while, for the first time ever, allowing physicians to use real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. Data from the study, which demonstrated successful achievement of all primary and secondary safety and effectiveness endpoints, supported U.S. Food and Drug Administration (FDA) 510(k) clearance of the system in 2016.

For over 20 years, stress echocardiography (SE) has been widely used to help clinicians diagnose ischemic heart disease, in which coronary arteries have narrowed, leading to restricted blood flow and damage to the heart.  However, in recent years, stress echocardiography has also become an established method to assess a much wider array of complex heart conditions, such as heart failure and valvular heart disease. A new document, The Clinical Use of Stress Echocardiography in Non-Ischaemic Heart Disease: Recommendations from the European Association of Cardiovascular Imaging (EACVI) and the American Society of Echocardiography (ASE), aims to establish guidance for how best to apply, perform and interpret SE for patients with a multitude of conditions.

Penn Medicine announced that its heart failure team is using big data to kick-start a project that is working to improve communication across the continuum of care, and ultimately reduce readmissions for heart failure patients.

Physicians and researchers at Texas Heart Institute are recruiting patients who suffer from heart failure to participate in the first-ever clinical study of combination adult stem cell therapy in cardiovascular medicine. Adult cell therapy has been studied in patients with heart disease with an excellent safety profile, though a combination of two cell types has not yet been evaluated in cardiovascular disease.

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Analytics Software

The analytics software comparison chart includes cardiovascular data analytics packages use to quickly find data points and make comparisons for everything from patient procedural parameters, numbers of procedures, room and equipment utilization, tech or physician statistics, inventory and other analysis. The software also can be used for benchmarking quality, determine staffing needs and schedules, business analytics, and future data mining of patient or department data.

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Advanced Revascularization-Chapter X (ARCH) Symposium

Lantheus Medical Imaging Inc. announced U.S. Food and Drug Administration (FDA) approval of a label update for Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension. The update removes the contraindication statement related to use in patients with a known or suspected cardiac shunt from the U.S. Prescribing Information.

Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for both the Assurity MRI pacemaker and the Tendril MRI pacing lead. Patients implanted with these low-voltage devices will have the ability to undergo full body magnetic resonance imaging (MRI) scans, if required. With the approval, the Assurity MRI pacemaker is now the world's smallest, longest-lasting wireless MRI-compatible pacemaker, according to Abbott.

Researchers have developed a technique that allows them to revive parts of human hearts in the laboratory for up to 12 hours while they search for hidden sources of irregular heartbeats.

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