Boston Scientific Corporation completed a first-in-human clinical trial utilizing the IntellaTip MiFi XP Ablation Catheter for the treatment of type 1 atrial flutter, an arrhythmia originating in the right atrium of the heart that affects nearly 1 million people in the United States. This single center feasibility trial enrolled 10 patients and was led by Prash Sanders, MBBS, Ph.D., FHRS, director of the Centre for Heart Rhythm Disorders at the University of Adelaide and the Royal Adelaide Hospital in Australia.

 

Sorin Group has received U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) application and clinical trial protocol to begin evaluating its Perceval S sutureless aortic tissue valve.

St. Jude Medical Inc. has received CE Mark approval of its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new portfolio is designed to lower the risk for lead abrasion and to ensure high-voltage therapy delivery.

ScottCare unveiled new advances for importing, monitoring and reviewing cardiac implantable electronic device (CIED) data at this year’s Heart Rhythm Society’s scientific session last week.

Vascular Solutions Inc. announced that it has re-launched the Venture catheter, a deflectable-tip catheter used to provide guidewire directional control in challenging coronary and peripheral interventional procedures. The device is available immediately in the United States and expected to become available in select international markets over the next few months.

The Spectranetics Corporation announced the U.S. Food and Drug Administration's (FDA) approval of its adjunct analysis plan associated with the EXCITE ISR clinical trial, studying the treatment of in-stent restenosis (ISR) in the legs. The goal of the adjunct analysis plan is to demonstrate statistically significant clinical superiority of laser atherectomy plus balloon angioplasty (PTA) compared with PTA alone, prior to full enrollment of the EXCITE ISR study.

New study data released at the Heart Rhythm Society (HRS) meeting last week validates the importance of contact force technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias. Unveiled in HRS abstracts, the data also demonstrated the ability of the Endosense TactiCath ablation catheter to detect excessive contact force during robotic catheter navigation.

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