GE Healthcare announced the U.S. Food and Drug Administration (FDA) approval of a new indication for AdreView (Iobenguane I 123 Injection), the first and only FDA approved molecular imaging agent to link nerve function in the heart to a patient’s mortality risk.[1] AdreView is approved for the scintigraphic assessment of myocardial sympathetic innervation (cardiac nerve activity) to assist in the evaluation of patients with New York Heart Association (NYHA) Class II or Class III heart failure and left ventricular ejection fraction (LVEF) ? 35 percent.[2]

 
Abbot MitraClip

Abbott announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted by majority (Yes: 5, No: 3) that the benefits of treatment with the MitraClip device outweigh its risks in patients with significant symptomatic mitral regurgitation (MR) who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the MR.

Network security issues, vital infrastructure upgrades, electronic health record (EHR) implementation and impending federal deadlines will guide priorities this year, according to an independent research study of 100 healthcare provider CIOs and senior IT executives that was commissioned by Level 3 Communications Inc.

Guerbet announced that the U.S. Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine), a gadolinium-based contrast agent (GBCA) indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

ACC HRS Appropriate Use Criteria ICDs CRTs

The American College of Cardiology (ACC) and Heart Rhythm Society (HRS), along with key specialty societies, released appropriate use criteria for implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices.

Cordis Corp. announced it has completed the acquisition of Flexible Stenting Solutions Inc., whose technology provides Cordis with the opportunity to evolve the S.M.A.R.T. stent platform to address unmet needs in the treatment of peripheral artery disease (PAD).

Svelte Medical Systems announced treatment of the first patient in the DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioabsorbable drug Carrier Technology) study at Middelheim Hospital in Antwerp, Belgium. DIRECT II is a prospective, randomized, multi-center clinical study comparing the safety and efficacy of the Svelte drug-eluting coronary stent Integrated Delivery System (IDS) to Medtronic’s Resolute Integrity drug-eluting stent. The study builds on the positive 6-month results of the DIRECT I first-in-man study which evaluated the Svelte drug-eluting coronary stent IDS in 30 patients in New Zealand. In DIRECT I, the Svelte drug-eluting coronary stent IDS met all study endpoints and demonstrated in-stent neointimal volume obstruction of 2.7 percent as assessed by intravascular ultrasound (IVUS), which is one-third to one-half the volumetric obstruction observed in market-leading drug-eluting stent first-in-man studies.

TherOx Inc. announced the initiation of its multicenter Investigational Device Exemption (IDE) pilot study of a second generation system that delivers supersaturated oxygen (SSO2) therapy for reduction of infarct size after an AMI. SSO2 therapy is intended to provide interventional cardiologists with the first treatment option beyond percutaneous coronary intervention (PCI) to salvage heart muscle in heart attack patients.

Northwest Community Healthcare (NCH) is unveiling new imaging and lab results functionality for its mobile app, MyNCH, which allows NCH Medical Group patients to view their lab and imaging results with just the tap of a finger on their smartphone.

Edwards Sapien, PARTNER, 3 year followup

The three-year results of a pivotal clinical study comparing the Edwards Sapien transcatheter heart valve and open-heart surgery demonstrated comparable outcomes. These new data from The PARTNER Trial were presented today as a late-breaking clinical trial at the American College of Cardiology's (ACC) 62nd Annual Scientific Session in San Francisco.
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