Sorin Group has received 510(k) clearance for commercialization of Sorin Connect, Sorin Group’s perfusion electronic charting system. The new Sorin Connect perfusion electronic charting system allows real-time data recording and trends visualization aimed to support clinicians and institutions in their perfusion management and documentation goals, during and after cardiac surgery.

The U.S. Food and Drug Administration (FDA) accepted Biomedica’s Investigational New Drug (IND) application for ClotFoam, a novel hemostat for intraoperative hemorrhage. The company will now conduct clinical trials supported by the National Heart Lung and Blood Institute of the National Institutes of Health. ClotFoam was originally conceived to control severe hemorrhage without need of compression in order to address unmet needs in gynecology, combat trauma and emergency medicine, as well as treatment of trauma in the operating room. Current trials are designed to prove the safety and efficacy of the product as an adjunct in solid organ hemorrhage. Once the agent is approved for this indication, the company will conduct additional trials as a primary treatment in trauma patients.

W. L. Gore & Associates announced a favorable ruling involving the Gore Helex Septal Occluder. The Hon. Judge Joan Ericksen of the U.S. District Court for the District of Minnesota ruled on July 23, 2013 in Gore’s favor that the Gore Helex Septal Occluder does not infringe the asserted claims of AGA Medical Corp.’s U.S. Patent 5,944,738 (‘738 patent) and granted Gore’s request for summary judgment of non-infringement.

Nanostim, leadless pacemaker
Biosense Webster, Thermocool Smarttouch
Biotronik, Ilesto 7, ICD

There have been several advances in electrophysiology (EP) technologies this past year, many of which were highlighted during the Heart Rhythm Society (HRS). These advances included a leadless pacemaker, new data on contact force sensing ablation catheters, a new electromapping system entering the market and new techniques to map and ablate atrial fibrillation (AF), said Jagmeet Singh, M.D., Ph.D., director, resynchronization and advanced cardiac therapeutics program at the new Mass General Institute for Heart, Vascular and Stroke Care. Singh also presented numerous sessions at HRS. 

A clinical study of two sets of 894 matched emergency department (ED) patients presenting with chest pain revealed that the use of coronary computed tomographic angiography (CCTA) led to fewer hospital admissions and shorter ED stays. According to lead researcher Michael Poon, M.D., of Stony Brook University School of Medicine, the findings provide evidence that CCTA offers an alternative means of improving the triage of chest pain patients.

Vanderbilt Heart and Vascular Institute is participating in the VELOCITY study, a randomized controlled clinical study to assess the safety and feasibility of a rapid cooling system for heart attack patients that could minimize damage to the heart.

Edwards Lifesciences received conditional investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial of its Edwards Sapien 3 transcatheter aortic heart valve and accessories.

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