News | Cath Lab

June 14, 2019 – An expert consensus statement provides recommendations for optimizing the financial operations of the ...

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News | Wearables

Bardy Diagnostics Inc. announced that its Carnation Ambulatory Monitor (CAM) was recognized with the “Best New Diagnostic Technology” award in the 2019 MedTech Breakthrough Awards Program. MedTech Breakthrough is an independent organization that recognizes the top companies and solutions in the global health and medical technology market. BardyDx earned the distinction for its P-wave centric ambulatory cardiac patch monitoring and arrhythmia detection technology.

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News | Stents Carotid

Silk Road Medical Inc. announced the presentation of real-world data for the treatment of patients with carotid artery disease at risk for stroke at the Society for Vascular Surgery 2019 Vascular Annual Meeting (VAM), June 12-15 in National Harbor, Md. In a headline presentation, Mahmoud Malas, M.D., of the University of California, San Diego School of Medicine shared updated results for the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project.

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Technology | Advanced Visualization

Three-dimensional (3-D) printing software and solutions company Materialise has received U.S. Food and Drug Administration (FDA) clearance for its Mimics Enlight cardiovascular planning software suite. The first release will support clinicians planning complex transcatheter mitral valve replacement (TMVR) procedures.

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News | Drug-Eluting Balloons

Orchestra BioMed Inc. announced it has formed a global strategic partnership with Terumo Corp. for development and commercialization of the Virtue Sirolimus-Eluting Balloon (SEB), one of Orchestra’s lead assets, in the percutaneous coronary and peripheral interventions field.

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Several electrophysiology advances presented as late-breaking studies at the 2019 Heart Rhythm Society (HRS) annual meeting in May made the top 25 list this month. Among these was the Parasym Salustim device ear clip that stimulates the vagus nerve, which was found to reduced AF burden compared with a sham procedure in the TREAT AF trial. Another innovation was first in human data on Medtronic's Extravascular ICD, which is its version of a subcutaneous ICD that does not require placing venous leads
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June 12, 2019 — Here is the list of the most popular content on the Diagnostic and Interventional Cardiology (DAIC) ...

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News | Left Atrial Appendage (LAA) Occluders

Boston Scientific Corp. has initiated the OPTION trial to compare safety and effectiveness of the next-generation Watchman FLX left atrial appendage closure (LAAC) platform to first-line oral anticoagulants (OAC) for stroke risk reduction in patients with non-valvular atrial fibrillation (AF) who undergo a cardiac ablation procedure. OACs used in the trial will include direct oral anticoagulants (DOAC) and warfarin.

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News | Genetic Testing

Specialized risk scores derived from testing that calculates the cumulative effect of an individual’s entire DNA sequence may reliably predict heart disease in people who have not yet had a heart attack, according to new research. The research is published in Circulation: Genomic and Precision Medicine, an American Heart Association journal.

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News | Ventricular Assist Devices (VAD)

In a letter sent to healthcare providers, the U.S. Food and Drug Administration (FDA) validates that Abiomed’s Impella RP heart pump is safe and effective for treatment of right heart failure. The letter comes after the FDA examined the results from Abiomed’s 18-month post-approval study (PAS) of 42 Impella RP patients. The data shows a 64 percent survival rate and 90 percent heart recovery for the subgroup of PAS patients who met the enrollment criteria of Impella RP’s premarket clinical studies. That survival rate is, as the FDA writes in its letter, “similar to the premarket clinical study survival rate,” which was 73 percent.

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News | Cardiovascular Business

Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma addressed the American Medical Association (AMA) Annual Meeting of the House of Delegates, which ran June 8-12 in Chicago. In her remarks, Verma addressed current efforts by the Trump Administration to enact healthcare reform. The following is a transcript of her remarks.

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News | Heart Valve Technology

June 11, 2019 — Abbott recently announced positive late-breaking data from its TRILUMINATE study of the company's ...

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Technology | Structural Heart Occluders

W. L. Gore & Associates (Gore) announced the U.S. Food and Drug Administration’s (FDA’s) premarket approval (PMA) of the Gore Cardioform ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects (ASDs). The FDA approval was supported by data collected from the pivotal stage of the Gore ASSURED Clinical Study, which demonstrated 100 percent closure success at the six-month evaluation in patients with a successful implant.

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Technology | Virtual and Augmented Reality

Medivis announced that its augmented reality (AR) technology platform for surgical applications, SurgicalAR, has received 510(k) clearance for clinical use in the operating room by the U.S. Food and Drug Administration (FDA). The New York City-based medical technology company will commence the immediate commercialization of the platform in the United States.

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News | Cardiac Imaging

The Amsterdam University Medical Center has won MR Solutions’ Image of the Year 2019 award for the best molecular research image. Preclinical image submissions came in from most of MR Solutions’ users across the world. The winners, which were presented at the International Society for Magnetic Resonance in Medicine (ISMRM) conference, May 11-16 in Montreal, QC, Canada, were chosen by a panel of leading academics who examined images from magnetic resonance imaging (MRI), positron emission tomography (PET) or computed tomography (CT) – or a combination of imaging modalities.

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News | Cardiac Diagnostics

Active duty Army personnel have worse cardiovascular health compared to people of similar ages in the civilian population, according to new research in Journal of the American Heart Association.

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