We’ve followed Abiomed, Inc.’s Impella® percutaneous heart pump quite extensively, most recently as the company has battled to retain FDA approved status for its core device last December, the authorities upgrading its regulatory classification to requiring PMA.
Now Abiomed has announced that it has enrolled a first patient in the IDE study that it hopes will see its Impella RP (Right Peripheral) device allowed onto the market.
Impella RP was first implanted in September 2010 in Vancouver.
Last November we reported that Abiomed was chasing U.S. FDA approval for its Impella RP device, here. At that time the company was commencing an IDE study in its quest for Humanitarian Device Exemption status in the U.S.
The Impella RP is a percutaneous heart pump that is implanted through a single access site in the patient’s leg and deployed through the venous system, across the right side of the heart without requiring a surgical procedure.
The RECOVER RIGHT clinical study, which received FDA IDE approval to begin in November 2012, will enroll 30 patients that present with signs of right side heart failure, require hemodynamic support, and are being treated in the catheterization lab or cardiac surgery suite.
Two patient cohorts will be examined in the RECOVER RIGHT study: Patients who develop right side heart failure within 48 hours post-left ventricular assist device (LVAD) implantation and secondly patients who develop right side heart failure subsequent to post-cardiotomy shock within 48 hours post surgery or post myocardial infarction.
The first enrollment in the RECOVER RIGHT study was a patient who developed right ventricular dysfunction after receiving an implantable LVAD. The Impella RP was implanted at Einstein Medical Center Philadelphia under the leadership of Mark Anderson, M.D., FACS, Chair of the Division of Cardiothoracic Surgery at Einstein. The Impella RP implant was performed by Christian Witzke, M.D., Director of the Structural Heart Disease Program and Parul Patel, MD., Director of the Cardiac Catheterization Laboratory at Einstein Medical Center Philadelphia.
“This is another example of how Einstein Healthcare Network is committed to providing the best possible outcomes for patients by conducting clinical trials to assess the safety and probable benefit of innovative technologies such as the Impella RP pump,” added Dr. Anderson, who is co-principal investigator of the RECOVER RIGHT study with William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital.
“The Impella RP gave this patient a level of hemodynamic support that allowed our heart failure team to treat the patient’s right-sided heart failure quickly in a minimally invasively manner,” said Dr. Witzke.
The Impella RP is currently the subject of an investigational device exemption (IDE) clinical study and is not currently approved for sale in the United States.
Source: Abiomed, Inc., Globe NewswireBased in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart