News

Millenium Research Group, Stents (peripheral), Cath Lab,

According to Millennium Research Group (MRG), efforts to streamline the regulatory approval process in Japan have resulted in the recent entry of numerous devices in the Japanese...

Edwards Lifesciences Corp. announced that Japan's Central Social Insurance Medical Council (Chuikyo) has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare's (MHLW)...

JenaValve TAVI System Canada

JenaValve Technology Inc. has successfully completed the first two implantations of its second-generation transapical JenaValve transcatheter aortic valve implantation (TAVI) system in Canada....

Boston Scientific Corp. has completed enrollment in the SuperNOVA trial – a global, single arm, prospective, multicenter clinical trial evaluating the long-term (12-month) safety and...

At the opening session of the third annual Amputation Prevention Symposium (AMP) in Chicago, Mary L. Yost, president of The Sage Group, delivered a lecture titled “Amputation Is It Really...

Frost & Sullivan has named Siemens Healthcare the "2013 North American Interventional Radiology Company of the Year" for its interventional imaging solutions in cardiology, radiology and...

Qinghui Chen, assistant professor in Michigan Tech’s kinesiology and integrative physiology department, wants to get to the bottom of two cardiovascular diseases: hypertension and congestive heart...

The idea that surgery to relieve the pressure caused by hemorrhaging in the brain is a perfect job for a robotic system is the basic premise of a new image-guided surgical system under...

Cardiac surgeons and cardiologists at the University of Maryland Heart Center are part of a multi-center clinical trial evaluating the efficacy of powering heart pumps through a skull-based...

August 19, 2013 — Medtronic Inc. announced the submission of its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon...

Patient enrollment has been initiated in a post-market registry for the Combo Dual Therapy Stent to evaluate its long-term safety and performance in routine clinical practice. The prospective,...

Former President George W. Bush underwent heart surgery on the morning of Aug. 6, 2013, to receive a stent after an artery blockage was discovered during his annual physical. The routine physical...

Colibri Heart Valve LLC announced that enrollment its first-in-human feasibility study is continuing, and early clinical results from the second implantation of the Colibri device confirm the...

IMRIS Inc. has obtained regulatory CE mark for Visius iCT, the first and only ceiling-mounted intraoperative computed tomography (CT)...

The William Stamps Farish Fund in Houston has donated $400,000 to a collaboration between the Institute for Computational Engineering and Sciences (ICES) at The University of Texas at Austin and...

This webinar summarizes the biological effects of X-ray radiation exposure in cath labs and methods to minimize dose to both clinical staff and patients. It defines strategies and technologies to...

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...

Gore Helex Septal Occluder Infringement Suit Ruiling AGA Medical Corp.

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...

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...

Edwards Sapien 3 Transcatheter Aortic Hear Valve Clinical Trial

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...