News | December 17, 2006

FDA: More Study Needed for CorCap

The FDA medical devices dispute resolution panel that met on Dec. 15 voted 3 to 1 to uphold a previous FDA decision that did not approve the CorCap cardiac support device. The agency says the heart device needs more study.

Acorn Cardiovascular Inc. disagreed with the FDA and said it had provided enough information to support a reasonable assurance of safety and effectiveness of its implantable mesh bag designed to support the blood-pumping muscle of patients with heart failure.

The device consists of a polyester mesh bag designed to be surgically wrapped around an enlarged heart to support the organ and potentially reverse the progression of heart failure, according to an AP news report on Yahoo.

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