Leading cardiac assist devices maker Abiomed (ABMD) has announced the first use of its Impella Right Peripheral (RP) cardiac pump in Canada. The device successfully supported the first patient for six days at the Providence Heart and Lung Institute at St. Paul’s Hospital in Vancouver.
Impella RP has been designed as a support for right ventricular dysfunction (right heart failure) which is characterized by the inability of the right side of the heart to adequately pump blood, resulting in accumulation of fluid in the body. Impella RP provides the flow and pressure necessary to compensate for right heart failure.
The device is inserted percutaneously (via the skin) into the heart’s right ventricle and delivers more than four liters of blood flow from the lower right atrium to the pulmonary artery. Impella RP enables surgeons to treat right ventricular dysfunction without cutting open the patient’s chest.
The Providence Heart and Lung Institute accessed Impella RP under Canada’s “special access” regulations, which allow healthcare providers emergency access to medical devices not commercially available in the country when conventional therapies have failed or are unsuitable.
Impella RP is still not commercially available in the U.S. In its first-quarter fiscal 2011 conference call, Abiomed stated that it is pursuing a strategy to collect patient data on the use of Impella RP outside the U.S. However, the company did not divulge any specific timeline for the U.S. regulatory approval and launch of the device.
Abiomed continues to enjoy strong demand for its Impella cardiac assist device systems (includes Impella 2.5 and Impella 5.0). The company is pursuing a number of strategies to boost Impella utilization. Roughly 595 U.S. commercial patients (a record) were treated with Abiomed’s Impella products in first-quarter fiscal 2011, representing a 74% annualized growth. Higher Impella sales continue to fuel double-digit revenue growth.
However, Abiomed does not expect to make any profit in fiscal 2011, in part, due to the hefty expenses associated with Impella. Moreover, the company’s legacy (non-Impella) business is shrinking and its strategy to add fewer new hospitals (or sites) with Impella 2.5 in fiscal 2011 may impair revenue growth. We are currently Neutral on Abiomed.
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