Abiomed Inc. ABMD recently announced that its Impella 2.5 heart pump has received FDA Pre-Market Approval (PMA) for use in high risk percutaneous coronary intervention (PCI) procedures. Notably, Impella 2.5, the world's smallest heart pump, is the first hemodynamic support device to receive such an indication.
With this approval, the Impella 2.5 can now be used as a temporary ventricular support device during high risk PCI performed in elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction. Use of the Impella 2.5 in these patients may prevent hemodynamic instability that may occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
We believe that this latest approval demonstrates the device’s safety and effectiveness in treating this complex patient population and will serve as a significant growth catalyst for the company.
The Impella 2.5 received 510(k) clearance from the FDA in 2008 and has been reimbursed by the Centers for Medicare & Medicaid Services for multiple indications, including high risk PCI, since 2008. Following the latest go-ahead, Abiomed will conduct a single arm, post approval study on the Impella 2.5, collecting data on high risk PCI patients, as part of the regulatory process.
Impella 2.5 is already supported by extensive clinical data which was submitted by Abiomed to the FDA to support this PMA as part of the 515 initiative. Data from FDA clinical trials such as PROTECT I and PROTECT II demonstrate that complex, high-risk patients undergoing protected PCI with Impella 2.5 support experience reduced adverse events, improved quality of life and reduced hospitalization days with fewer repeat procedures.
The Impella Platform
Apart from Impella 2.5, Abiomed’s Impella platform consists of Impella CP and Impella 5.0, both of which currently enjoy FDA clearance for partial to full circulatory support for up to six hours.
The Impella RP, which is the latest addition to the portfolio, received Humanitarian Device Exemption (HDE) approval in January this year. In our opinion, FDA approval for Impella RP expands the company’s addressable market and bodes well for the Impella line as a whole. Notably, Impella RP is the first percutaneous single access heart pump designed for right heart support to receive regulatory clearance.
We note that Abiomed is enjoying robust demand for its Impella line of products. With the last reported quarter clocking a double-digit rise in Impella revenues, Impella utilization continues to grow at a remarkable pace. We believe that strong demand for Impella products will continue to drive the company’s top line.
Remarkably, Abiomed has also raised its fiscal 2015 revenue guidance taking into consideration the strength across its Impella product line. The company now expects revenues in the range of $223–$226 million (up from the earlier guidance of $209–$212 million). The upgraded guidance reflects year-over-year revenue growth of 21% to 23%.
Stocks to Consider
Currently, Abiomed sports a Zacks Rank #1 (Strong Buy). Other well-performing stocks in the medical instruments industry include Inogen INGN, Edwards Lifesciences Corp. EW and Fluidigm Corp. FLDM. While Inogen sports the same Zacks Rank as Abiomed, both Edwards Lifesciences and Fluidigm carry a Zacks Rank #2 (Buy).
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