News

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...

August 5, 2013 — AstraZeneca announced results from a new sub-analysis of the PLATO study that evaluated the incidence of stent thrombosis in patients with acute coronary syndrome (ACS).

Thubrikar Aortic Valve’s Optimum TAV, transcatheter aortic valve implantation (TAVI) system, has surpassed 200 million cycles in an ongoing durability test — which simulates over five years in...

Impella CP Abiomed 15,000 Patients United States 1,000 Global Patients

Abiomed Inc. reported that physicians have implanted more than 15,000 Impella pumps in U.S. patients requiring hemodynamic support. The 15,000th Impella procedure took place at Mercy General...

The U.S. Food and Drug Administration (FDA) recently granted market clearance for a hand lotion designed to offer radiation protection from X-rays. Physicians such as interventional cardiologists...

Mercator MedSystems has been issued U.S. Patent 8,465,752, which protects the company’s sole U.S. rights to deliver drugs or other nerve modifying agents to tissue surrounding arteries for...

InspireMD MGuard Prime Prime Embolic Protection Stent Clinical Trial

InspireMD Inc. said the first patient has been enrolled in the Master II IDE clinical trial to evaluate the safety and effectiveness of the MGuard Prime Embolic Protection Stent (EPS) in patients...

The healthcare sector in the United States is facing several reforms, mainly from the implementation of the Patient Protection and Affordable Care Act. However, the results from a survey of 1,710...

MEDTRONIC, symplicity renal denervation catheter

One of the exciting new frontiers for interventional cardiology is the use of renal denervation therapy to treat pharmacologically uncontrolled hypertension. It is estimated there are more...