Direct Flow Medical Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin the SALUS feasibility trial of the Direct Flow Medical Transcatheter Aortic Heart Valve System. The device encompasses a transcatheter aortic heart valve with a metal-free frame and flexible, low-profile delivery system that virtually eliminates aortic regurgitation. It is designed to improve the long term survivability of patients by resolving the clinical issues associated with current commercial valves.

C. R. Bard Inc. announced the enrollment of the first patient into the Lutonix Below the Knee (BTK) Clinical Trial at The Cardiac and Vascular Institute in Gainesville, Fla. The purpose of this pivotal global, multi-center randomized Investigational Device Exemption (IDE) trial is to compare the safety and effectiveness of the Lutonix 014 Drug Coated PTA Dilatation Catheter to a standard angioplasty balloon catheter for the treatment of critical limb ischemia.

AngioLight has successfully completed an initial animal study of the AngioLight System at Fu Wai Hospital, a leading cardiovascular center located in Beijing. The study paves the way for AngioLight to go forward in China with full-scale animal and clinical testing of the system, which will begin following the anticipated completion of study protocols, hospital review and required China Food and Drug Administration (CFDA) approvals.

Medtronic Inc. announced new data demonstrating that simultaneously pacing the lower chambers of the heart, or biventricular (BiV) pacing with a cardiac resynchronization therapy (CRT) device, significantly improves heart failure symptoms and quality of life in a subset of heart failure patients.

Led by the launch of the Aplio 500 and Aplio 300 ultrasound systems, Toshiba America Medical Systems Inc. saw a 28 percent U.S. ultrasound business growth in 2012, far exceeding the industry’s 3 percent, according to Klein Biomedical Consultants Inc.’s industry report published in April 2013.


Extracorporeal membrane oxygenation (ECMO), a procedure traditionally used during cardiac surgeries and in the intensive care unit (ICU) that functions as an artificial replacement for a patient's heart and lungs, has also been used to resuscitate cardiac arrest victims in Japan, Taiwan and South Korea. Now, a novel study of this technique in the United States has been completed by researchers at the Perelman School of Medicine at the University of Pennsylvania, indicating a potential role for this intervention to save patients who are unable to be resuscitated through conventional measures.
The Heart Rhythm Society (HRS) 2013 scientific sessions covered the latest research and technology in electrophysiology (EP). Here are a few trends and innovative new technologies I wanted to highlight from the meeting.
 
One of the most innovative technologies discussed at the meeting was the Nanostim leadless pacemaker.

GE Healthcare has announced that all of its new computed tomography (CT) products meet the Medical Imaging and Technology Alliance (MITA) smart dose standard that raises the bar for CT dose management.

Data presented at Heart Rhythm 2013 show that Medtronic Inc. Lead Integrity Alert (LIA) software detected pace/sense lead issues in non-Medtronic leads at a greater rate than standard impedance monitoring alone (impedance monitoring measures the electrical continuity of a lead four times per day). The retrospective analysis, which focused on Endotak leads (Boston Scientific) and was presented by Kenneth Ellenbogen, M.D., shows that for every one Endotak pace/sense lead issue detected by impedance monitoring, the LIA software detected four cases that impedance monitoring alone missed. LIA is not currently FDA approved for use with non-Medtronic leads.

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