News | December 19, 2012

FDA Grants IDE Trial Investigating Potential Infarct Size Reduction with TandemHeart System

TRIS trial to determine effect of ventricular unloading on myocardial salvage after acute myocardial infarction

December 19, 2012 — CardiacAssist Inc. announced it has received investigational device exemption (IDE) approval from the U.S. Food & Drug Administration (FDA) for a pivotal clinical study of the TandemHeart circulatory support system. The TandemHeart to Reduce Infarct Size (TRIS) trial will evaluate the effectiveness of ventricular unloading on the reduction of infarct size for patients who have suffered a severe heart attack.

“The approval of the pivotal TRIS trial represents a major milestone for our company and the industry,” said John Marous, president and CEO of CardiacAssist. “With the completion of our pre-clinical animal studies, which showed a strong correlation between high degrees of ventricular unloading and improved myocardial salvage, we are excited to extend this concept to human trials and hopefully achieve similar clinical benefits.”

Patients enrolled in the TRIS trial will be randomized to receive either conventional therapy or a TandemHeart device to unload the left ventricle along with percutaneous coronary intervention (PCI). The primary efficacy endpoint of the study is improvement in myocardial salvage index (MSI). Additionally, the economic impact of TandemHeart therapy will be studied through secondary endpoints, including long-term mortality and the rates of repeat hospitalization and implantable cardioverter-defibrillator (ICD) usage. A reduction in these rates could decrease the total cost of treatment for this patient population.

The TRIS trial is expected to begin enrollment in early 2013 and will include up to 20 hospitals, with leadership from principle investigators Biswajit Kar, M.D., chief of the Center for Advanced Heart Failure at Memorial Hermann Heart and Vascular Institute in Houston; and David Holmes, M.D., professor of medicine at the Mayo Clinic College of Medicine in Rochester, Minn., and immediate past president of the American College of Cardiology (ACC).

For more information: www.cardiacassist.com/innovation-research/tris-trial

Related Content

FDA Confirms Impella RP is Safe and Effective
News | Ventricular Assist Devices (VAD) | June 12, 2019
 In a letter sent to healthcare providers, the U.S. Food and Drug Administration (FDA) validates that Abiomed’s Impella...
Impella SmartAssist Platform Launches at SCAI
News | Ventricular Assist Devices (VAD) | May 22, 2019
Abiomed announced that the Impella CP with SmartAssist will be commercially available beginning at the 2019 Society for...
FDA Approves Impella 5.0 and Impella LD Extended Duration of Use
Technology | Ventricular Assist Devices (VAD) | May 14, 2019
The U.S. Food and Drug Administration (FDA) has approved the expansion of Abiomed’s Impella 5.0 and Impella LD...
FDA Approves Initiation of STEMI DTU Pivotal Randomized Controlled Trial
News | Ventricular Assist Devices (VAD) | May 02, 2019
Abiomed announced that, on April 26, the U.S. Food and Drug Administration (FDA) approved initiation of the ST-...
Cardiogenic Shock Survival Rates Improve in Three Years Since Impella FDA Approval
News | Ventricular Assist Devices (VAD) | April 05, 2019
Three years ago this week, Abiomed's Impella heart pump received U.S. Food and Drug Administration (FDA) premarket...
HeartMate 3 Pump Shows Superior Outcomes in Advanced Heart Failure
News | Ventricular Assist Devices (VAD) | March 22, 2019
Severely ill patients with advanced heart failure who received the HeartMate 3 left ventricular assist device (LVAD)...
Leviticus Cardio and Jarvik Heart Unveil Wireless Heart Pump System
News | Ventricular Assist Devices (VAD) | February 11, 2019
Heart failure experts at the National Research Center for Cardiac Surgery in Astana, Kazakhstan, recently announced the...
Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure
Technology | Ventricular Assist Devices (VAD) | July 17, 2018
Medtronic plc recently received U.S. Food and Drug Administration (FDA) approval for a less-invasive implant approach...
CorWave's Next-generation Neptune LVAD Receives Funding

Image courtesy of CorWave

News | Ventricular Assist Devices (VAD) | July 11, 2018
French-based CorWave announced that its CALYPSO program has received 14 million euros to develop CorWave Neptune, a new...
Overlay Init