Biotronik enrolled the first patients in an expansion of their ongoing ProMRI trial to test its pacemaker system.

Phase A of the study evaluated the safety of current Biotronik pacemaker systems during magnetic resonance imaging (MRI) scans with exclusion zones of the chest area, and was completed on November 18, 2013.

The Gagnon Cardiovascular Institute at Morristown Medical Center adopted a minimally invasive medical device to treat patients with severe aortic stenosis who are too ill or frail to have their aortic valves replaced trough traditional open-heart surgery. 

January 28, 2014 — The U.S. Food and Drug Administration (FDA) approved W. L. Gore & Associates’ 25 cm Gore Viabahn Endoprosthesis with Heparin Bioactive Surface for the treatment of symptomatic peripheral arterial disease (PAD) lesions in the Superficial Femoral Artery (SFA). The 25 cm endoprosthesis is designed to cover long-segment lesions in the SFA, potentially reducing the need for multiple devices.

ReCor Medical advanced its Paradise System for renal denervation (RDN) for treatment resistant hypertension (HTN).

The U.S. Food and Drug Administration (FDA) approved Pressure Products Inc.’s SafeSept Needle Free Transseptal Guidewire for use with any introducer system when crossing the interatrial septum. The device assists in transseptal procedures and is designed to create the primary puncture in the interatrial septum providing access from the right to left side of the heart without using a transseptal needle.

AtheroMed, a developer of catheter technologies for treating peripheral artery disease (PAD), received clearance from the U.S. Food and Drug Administration (FDA) to market the Phoenix Atherectomy System, which allows physicians to treat PAD with a low profile atherectomy catheter that continuously removes diseased material as it is debulked and does not require specialized capital equipment.

Experts from the American Society of Echocardiography (ASE), in collaboration with the Society for Cardiovascular Magnetic Resonance (SCMR) and the Society for Pediatric Radiology (SPR), released a guideline, Multimodality Imaging Guidelines for Patients With Repaired Tetralogy of Fallot: A Report from the American Society of Echocardiography Writing Group, to help optimize lifetime management of patients with repaired tetralogy of Fallot (TOF). 

A paper in World Heart Federation’s journal Global Heart advocates for the inclusion of ultrasound in medical education programs to fully realize its benefits as early as possible. The review is by J. Christian Fox, professor of clinical emergency medicine and director of instructional ultrasound, University of California Irvine School of Medicine and colleagues.

Claret Medical Inc. received CE marking for the Sentinel Cerebral Protection System (CPS) for embolic protection during transcatheter aortic valve replacement (TAVR). 

Sapien 3, TAVR, CE mark, european approval

Edwards Lifesciences Corp. received CE marking for its Edwards Sapien 3 transcatheter aortic valve.
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