Industry Forum

Data Presented at ACC Reinforce Positive Clinical Outcomes for Patients Receiving Medtronic’s CoreValve® System

New clinical data presented this morning at the American College of Cardiology (ACC) 61st Annual Scientific Session & Expo reinforce positive outcomes for high-risk patients who received the Medtronic CoreValve® System as part of the Medtronic CoreValve ADVANCE Study. The results showed that patients in a real-world setting experienced high procedural success combined with positive clinical outcomes, and add to the existing body of clinical evidence collected to date for the CoreValve System (under investigation in the U.S.).

- Industry Forum Headlines -

Sorin Group Announces First Implant In U.S. Study Of Stentless Pericardial Aortic Valve
01-March-2012

Sorin Sorin Group, announced initiation of a United States investigational device exemption (IDE) study for its Freedom Solo™ Stentless Pericardial aortic valve. The first patient was enrolled in the Freedom Solo IDE study at St. Vincent’s Heart Center of Indiana in Indianapolis by David Heimansohn, M.D., F.A.C.S, the study’s principal investigator.

Data Presented At STS Reinforce Positive Clinical Outcomes For Medtronic Corevalve® System Using Direct Aortic Approach
14-February-2012

Multicenter Experience Demonstrates Surgical Approach, with Recent CE Mark, is a Feasible Alternative for Transcatheter Aortic Valve Implantation

Medtronic, Inc. issued a statement on the results of two studies evaluating the use of the Medtronic CoreValve® System delivered through the direct aortic implantation approach. Data presented at the STS 48th Annual Meeting demonstrate positive outcomes when the CoreValve System is implanted using the direct aortic approach.

Medtronic Completes Enrollment Of Extreme Risk Patient Group In Corevalve® U.S. Pivotal Trial
25-January-2012

CoreValve U.S. Trial to Continue Enrolling Patients in High Risk Study, and Will Maintain Therapy Access to Extreme Risk Patients via Continued Access Phase of Trial

Medtronic, Inc. announced it has completed patient enrollment in the extreme risk study in its CoreValve U.S. Pivotal Trial. The company also received approval from the U.S. Food and Drug Administration (FDA) for an extended investigation (under the FDA’s Continued Access Policy) to continue enrolling extreme risk patients under a Continued Access Study protocol. In the Trial’s second study evaluating high risk patients for aortic valve surgery, enrollment completion is anticipated later this year.

Medtronic Begins Transcatheter Aortic Valve Trial in Japan
02-November-2011

Medtronic, Inc. announced the first implant in a clinical trial in Japan that will evaluate the safety and effectiveness of the Medtronic CoreValve® System

Medtronic The successful procedure in the trial was led by Professor Yoshiki Sawa of the Department of Cardiovascular Surgery at Osaka University Hospital. “With the number of aortic valve stenosis patients steadily rising as the Japanese population ages, we consider this an important step towards the introduction of a new therapeutic option to the healthcare system,” said Professor Sawa.

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