Abiomed Granted IDE to Evaluate ‘World’s Smallest Heart Pump’

Abiomed said it has received approval for an IDE to start an early feasibility study of what it is calling the “world’s smallest heart pump.”   The Danvers, MA-based company said the first-in-human trial will look at the 9 French Impella ECP heart pump in high-risk percutaneous coronary intervention (PCI) patients.   The primary endpoint of the study is successful delivery, initiation, and maintenance of adequate hemodynamic support and a composite rate of major device-related adverse events during high-risk PCI.   The study protocol will enroll and treat up to five U.S. patients who require revascularization. If successful, enrollment will be expanded to additional patients, pending FDA approval. Study investigators will begin patient enrollment later this calendar year for the first-in-human trial.   The firm said the pump can achieve peak flows greater than 3.5 L/min and is delivered through a slender-profile sheath. It is un-sheathed in the descending aorta and expands to approximately 18 Fr. Using a specially designed pigtail, it crosses the aortic valve without a wire, and pumps from inside the ventricle. When the procedure is complete, the pump is re-sheathed back down to 9 Fr and removed with that same profile.   News of Abiomed’s IDE comes just a few days after the company announced it was granted emergency use authorization ...
Source: MDDI - Category: Medical Devices Tags: Cardiovascular Regulatory and Compliance Source Type: news