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Condition: Hole in the Heart
Education: Training

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Total 3 results found since Jan 2013.

Recognizing and reacting to complications of trans-septal puncture.
Authors: Salghetti F, Sieira J, Chierchia GB, Curnis A, de Asmundis C Abstract INTRODUCTION: The transseptal puncture (TSP) enables access to the left heart, through the fossa ovalis (FO), both in electrophysiology and in cardiac interventional procedures. TSP is usually safe in experienced hands. Sometimes TSP can be technically demanding and carries the risk of severe complications in approximately 1%. While performing a TSP, every effort should be taken in order to avoid complications. In the event of complications, prompt recognition and reaction are essential and a combined "heart-team" management may be the m...
Source: Expert Review of Cardiovascular Therapy - November 24, 2017 Category: Cardiology Tags: Expert Rev Cardiovasc Ther Source Type: research

Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in AugustĀ 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 70 Summary of PMA Originals Under Review Total Under Review: 57 Total Active: 28 Total On Hold: 29 Summary of PMA Supplements Under Review Total Under Review: 569 Total Active: 422 Total On Hold: 147 Summary of All PMA Submissions Originals: 5 Supplements: 90 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 70 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 229.0 FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news

HeartStitch touts new PFO closure method
Structural heart focused HeartStitch said today its NobleStitch EL device was used to repair 3 patients with patent forman ovale heart defects in Astana, Kazakhstan. A patent foramen ovale is a congenital heart disease in which hole in the heart that normally seals at birth remains open, and can lead to severe migraines, visual auras and stroke, the company said. The procedures were performed by Dr. Michael Mullen and guided by Anthony Nobles at the National Research Cardiac Surgery Center in Astana, according to the company. “We are gratified that our colleagues from abroad have brought this technology to Kazakhstan...
Source: Mass Device - September 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular HeartStitch Source Type: news