The FDA has granted pre-market approval to the Impella RP heart pump used in treating right heart failure, Abiomed announced Sept. 20.
According to a press release, the Impella RP system is “indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device (LVAD) implantation, myocardial infarction, heart transplant, or open-heart surgery.”
In a previous trial of 30 patients with right ventricular failure (RVF), the device was associated with 73 percent survival at 30 days. Patients who developed RVF following LVAD implantation had an 83.3 percent 30-day survival rate. Those who developed RVF within 48 hours of post-cardiotomy shock or post-acute MI had a survival rate of 58.3 percent.
Delivered via catheter through the femoral artery in the thigh, the pump provides more than four liters of blood per minute for hemodynamic support, allowing the heart to recover.
"The Impella RP has opened up a new era in cardiovascular medicine,” Mark B. Anderson, MD, co-principle investigator of the pilot trial, said in the release. “With its percutaneous, single vascular access, the Impella RP offers physicians a minimally-invasive procedure for patients who have previously had limited options for treatment of right heart failure. The cumulative data from the FDA studies demonstrate that Impella RP potentially offers survival benefits for these critically ill patients in need of hemodynamic support."
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.