The FDA has approved the latest version of Abiomed’s Impella CP heart pump system. New features of the Impella device include an optical pressure sensor and revised controller.
Abiomed won approval for the Impella 2.5 system in 2015. Since then, the company has filed a string of supplements covering improvements to the device. The FDA has now signed off on Abiomed’s latest premarket approval supplement.
The filing covers Impella CP heart pump with SmartAssist. Like its predecessors, the device takes blood from the left ventricle and pumps it into the ascending aorta to unload the left ventricle and stabilize hemodynamics in patients with advanced heart failure and other cardiovascular conditions.
Abiomed’s changes center on the inclusion of an optical pressure sensor and modification of the Impella controller.
“The ability to view fundamental hemodynamic data such as LVP, EDP and CPO directly on the Impella console provides critical information for clinical decision-making,” Henry Ford Hospital’s William O’Neill, M.D., said in a statement. “Additionally, access to data and real-time pump position improves efficiency for nurses and physicians in the ICU and CCU.”
Abiomed laid the groundwork for the new version of the Impella device in 2010 when it partnered with Opsens to integrate a fiber optic sensor into its products. Four years later, Abiomed paid $1.5 million and committed to up $4.5 million in milestones for an exclusive worldwide license to the miniature pressure sensor. Some of the $4.5 million was tied to regulatory progress.
The approval comes weeks after Abiomed paid $3.1 million to settle allegations that it took doctors for fancy dinners to encourage them to use an earlier iteration of its Impella heart pump.