April 12, 2012 — Several innovative cardiovascular and radiology technologies were featured in Medical Device and Diagnostic Industry (MD+DI) magazine’s April issue, which also announced the finalists in the 2012 Medical Design Excellence Awards (MDEA) competition.

April 12, 2012 - Abiomed Inc., a provider of heart support technologies, announced it has received CE marking approval in the European
Union to market the Impella cVAD device, a new percutaneous Impella heart pump that provides peak flow of approximately 4 liters of blood per minute. The Impella cVAD is designed to provide temporary circulatory support via a minimally invasive, catheter-based pump that is insertedpercutaneously, without the need for surgical intervention.


The gloves are off and the fight has begun between St. Jude Medical and Medtronic over clinical data regarding their implantable cardioverter defibrillator (ICD) leads. St. Jude, the medical device manufacturer of the recently recalled Riata and Riata ST ICD leads, is defending itself this week against a report in the Heart Rhythm Journal, from the Heart Rhythm Society, by Robert Hauser, M.D., FACC, of the Minneapolis Heart Institute (Hauser et al., “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads”).

April 12, 2012 – Terumo Interventional Systems recently announced the nationwide availability of the Azur D35 Framing Coil, the first truly detachable coil that precisely frames the targeted area for peripheral embolization.

Philips Healthcare recently installed an Allura Xper FD 20/20 biplane angiography X-ray system at Primary Children's Medical Center in Salt Lake City, with a National Basketball Association (NBA) theme to put children at ease prior to and during interventional radiology procedures.

April 12, 2012 - Boston Scientific Corporation announced the United States market launch of its Z Flex-270 Steerable Sheath. The device is intended for use in a wide range of electrophysiology (EP) procedures to facilitate the introduction and placement of diagnostic and therapeutic catheters within the heart. The company plans to launch the product immediately in the United States.

April 12, 2012 - Edwards Lifesciences Corp. said a U.S. Food and Drug Administration (FDA) advisory panel will review the company's request to expand the indication for the Sapien transcatheter aortic valve to high-risk surgical patients. The premarket approval (PMA) application is set to be reviewed June 13, 2012. Edwards submitted a PMA application in April 2011 based on data from the high-risk cohort (Cohort A) of the PARTNER Trial, for approval of this therapy in the treatment of patients with severe, symptomatic aortic stenosis who are at high risk for surgery.

The U.S. Food and Drug Administration (FDA) approved an expanded indication for Medtronic’s cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices. With the approval, this advanced therapy can now be used earlier, in a mildly symptomatic heart failure patient population, potentially improving survival, reducing hospitalizations and preventing disease progression.

April 12, 2012 — The Maryland General Assembly set a high bar for the nation and showed its commitment to patients by passing legislation establishing an independent review of the placement of stents in heart patients to ensure consistency with guidelines developed by the American College of Cardiology and other organizations, the Maryland Chapter of the American College of Cardiology said.

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