The US Food and Drug Administration (FDA) granted Abiomed’s application for a humanitarian device exemption for the Impella RP System, a percutaneous medical device designed to assist the heart with circulation in adult or pediatric patients who have right heart failure or inadequate blood flow from the right side of the heart.1
The FDA designates a humanitarian use device as one intended for diseases or conditions that affected fewer than 4,000 people per year.2
The device consists of a thin catheter with a small heart pump at one end.3
It also includes an external console used to control the heart pump and a purge cassette (infusion pump) used to flush the catheter. The device is inserted into the femoral vein through a small incision in the leg and delivered to the right side of the patient’s heart. It unloads the right ventricle by pumping blood from the inferior vena cava into the pulmonary artery.3
According to the FDA, Impella RP is appropriate for patients whose right heart fails (1) after receiving a heart pump to support the left side of the heart; (2) because of a heart attack; (3) after a heart transplant; or (4) after heart surgery.3
The pump is left in place for 14 days, during which time the patient must remain in the hospital. By assisting the heart in pumping blood, the Impella RP System gives the patient’s heart an opportunity to rest and recover and hopefully begin pumping sufficient blood on its own.
In a press release, William O’Neill, MD, medical director of structural heart disease at Henry Ford Hospital, Detroit, Michigan, and a principal investigator for the pivotal Recover Right clinical trial of Impella RP, said, “Right-sided heart failure carries a high risk of mortality, and historically has been difficult for physicians to treat minimally invasively.”4
In the multicenter nonrandomized trial, the Impella RP System was implanted in 30 adults, 89% of whom had congestive heart failure. One group of patients had experienced right ventricular failure (RVF) within 48 hours after implantation of a left ventricular assist device. A second group had developed RVF within 48 hours after cardiotomy or myocardial infarction shock.4
Patients had persistent RVF despite receiving high doses of inotrope or vasopressor medications.5
Most patients had multiple comorbidities, including a history of arrhythmia (60%), an implantable cardioverter defibrillator or pacemaker (57%), diabetes (53%), chronic kidney disease (38%), or prior cerebrovascular accident (20%).5
At baseline, 79% of patients were assessed as New York Heart Association (NYHA) classification IV, which means they were unable to engage in physical activity without feeling discomfort and might even experience heart failure or angina while resting.6
The primary endpoint of the trial was survival at 30 days, or at discharge after the device was removed if the patient was discharge more than 30 days after removal, or until anesthetization for subsequent longer-term therapy.5
Overall, the 3-day survival rate was 73%, which was significantly better than typical survival for patients meeting the study’s inclusion criteria.5
Cardiac index, central venous pressure, and other hemodynamic measures improved on average after the device was implanted. Use of inotropes initially rose and then declined below baseline levels. The device remained in place for a mean of 3 days.5
Although 60% of patients experienced a major bleeding episode once the Impella RP was in place, most events were related to cardiovascular surgeries that precipitated need for the device.5
Device-associated bleeding was less than 100 mL for 93% of patients. Rates of vascular complications were also low. Seven patients had device malfunctions, but only one suffered a related adverse event.5
In a press release on the Recover Right study, co-investigator Mark Anderson, MD, chair of the division of cardiothoracic surgery at Einstein Medical Center in Philadelphia, Pennsylvania, said, “The trial results were favorable and the 30-day outcomes appear promising compared with clinical data from surgical RV assist devices.” He noted, however, that the study was not powered to make a statistical comparison. “Overall, the results show that the percutaneous approach with Impella RP potentially offers significant advantages,” said Anderson.4
Abiomed receives FDA HDE approval for the Impella RP: first FDA approved percutaneous single access heart pump designed for right heart support [press release]. http://investors.abiomed.com/releasedetail.cfm?ReleaseID=893135. Published January 27, 2015. Accessed February 11, 2015.
US Food and Drug Administration. Medical devices: humanitarian device exemption overview. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption. Updated June 26, 2014. Accessed February 11, 2015.
US Food and Drug Administration. Medical devices: Impella RP System – H140001. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm433494.htm. Updated February 9, 2015. Accessed February 11, 2015.
Clinical trial results for Impella RP right ventricular heart failure trial, Recover Right, released at TCT 2014 [press release]. http://investors.abiomed.com/releasedetail.cfm?ReleaseID=871213. Published September 26, 2014. Accessed February 11, 2015.