Abiomed, a US-based provider of heart support technologies, has enrolled the first patient in an investigational device exemption (IDE) study of its percutaneous heart pump.
Under the minimally invasive procedure, which was performed at Einstein Medical Centre, Philadelphia, the Impella RP (right peripheral) pump was implanted through a single access site in the patient’s leg and deployed across the right side of the heart without requiring a surgical procedure.
The enrolled patient had developed right ventricular dysfunction after receiving an implantable left ventricular assist device (LVAD).
The trial will enrol 30 patients who have signs of right side heart failure, require hemodynamic support and are being treated in the catheterisation lab or cardiac surgery suite.
Patients who develop right-side heart failure within 48 hours of post-LVAD implantation or after post-cardiotomy shock within 48 hours post-surgery or post-myocardial infarction will be enrolled in the trial.
Einstein Medical Centre Philadelphia cardiothoracic surgery division chair Dr Mark Anderson said; "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."
Einstein Medical Centre Philadelphia structural heart disease programme director Dr Christian Witzke said; "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."
The device is not currently approved for sale in the US.