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.

 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.

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.

June 11, 2019 — Abbott recently announced positive late-breaking data from its TRILUMINATE study of the company's minimally invasive tricuspid valve repair system.

Mastering the Management of Aortic Valve Disease: A Case Based Approach

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.

World Heart Summit Heart Congress 2019

ESC Asia with APSC & AFC

The European Society of Cardiology (ESC) is expanding the boundaries of cardiovascular medicine with a new partner conference in Asia. The latest science put in a clinical Asian perspective. Join renowned opinion leaders from across Europe and the Asia Pacific region for informal chats and cutting-edge sessions.

Hear the latest on:

  • Prevention
  • Imaging
  • Arrhythmias
  • Heart Failure
  • Intervention
  • And much more...

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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