Abiomed, Inc. is reporting that the FDA has issued 510(k) clearance for the company’s Impella® 5.0 and Impella® LD Circulatory Support Devices. The Impella® 5.0 is shown above, and Impella® LD is in the lower picture. As we have said before, the big trick is for the company to convince cardiologists and cardiac surgeons that its devices are better, and maybe even safer, than commonly used Intra Aortic Baloon Pumps (IABPs). We, of course, have been following the Impella system for many years now, ever since it was a German invention.
More from the announcement by the company:
Similar to the Impella 2.5, which received 510(k) clearance on June 2, 2008 for partial circulatory support for periods of up to six hours, the Impella 5.0 and Impella LD devices are minimally invasive catheter-based pumps, designed to provide temporary circulatory support and reduce the workload of the heart muscle. The pump is approximately the size of a pencil with a small nine French catheter, which drives up to five liters of blood flow per minute, a flow rate typically adequate to fully support the average adult.
“Formerly, only patients with a grave prognosis received aggressive circulatory support due to the invasiveness and potential complications associated with conventional surgery devices,” said Anson Cheung, M.D., Surgical Director of Heart Transplantation at St. Paul’s Hospital in Vancouver, British Columbia. “The availability of the Impella 5.0 and Impella LD has reduced our threshold to implanting patients with a temporary circulatory support device and offers a potential benefit to reduce the likelihood of escalating therapy, such as implantable devices or heart transplantation. We have already seen patient success from Impella 5.0 and LD in providing the therapeutic benefit of ventricular unloading, which helps to interrupt the progression of heart muscle damage and potentially repair reversible damage.”
The Impella 5.0 further enhances Abiomed’s heart recovery portfolio, providing cardiologists and surgeons with the clinical flexibility to select and deploy circulatory support devices for patients based on the severity of cardiac dysfunction, the amount of flow needed while addressing the dysfunction, and the preferred implant approach. In application, Impella is intended to increase the flow delivered by the heart, which can potentially reduce the work of the heart and augment coronary flow.
“Now, both cardiologists and surgeons can use the minimally invasive Impella 5.0 and Impella LD devices for critical patients whose conditions require high-flow circulatory support,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “This FDA clearance represents Abiomed’s ability to create new heart support technologies and execute on the regulatory path. This is the eighth FDA regulatory clearance or approval in the past four years.”
“Formerly, only patients with a grave prognosis received aggressive circulatory support due to the invasiveness and potential complications associated with conventional surgery devices,” said Anson Cheung, M.D., Surgical Director of Heart Transplantation at St. Paul’s Hospital in Vancouver, British Columbia. “The availability of the Impella 5.0 and Impella LD has reduced our threshold to implanting patients with a temporary circulatory support device and offers a potential benefit to reduce the likelihood of escalating therapy, such as implantable devices or heart transplantation. We have already seen patient success from Impella 5.0 and LD in providing the therapeutic benefit of ventricular unloading, which helps to interrupt the progression of heart muscle damage and potentially repair reversible damage.”
Press release: Abiomed Receives FDA 510(k) Clearance for Impella(R) 5.0 and Impella(R) LD…
Product page @ Abiomed: Impella…
Flashbacks: Impella 2.5 Heart Pump Given Green Light in US; Impella 2.5 Heart Pump Performs Well in a Feasibility Trial ; Impella Percutaneous VAD to be Studied for Acute MI Patients; impella® recover LV; Impella Recover Devices Approved in Germany for Reimbursement