Tuesday morning Abiomed announced that its Impella RP device, which provides temporary support for patients with right ventricular failure, received CE mark approval in Europe. This is a positive development for the company, and while we do not expect an immediate bump in sales.
The Impella RP is similar to Abiomed’s flagship left-side Impella device in that RP is a percutaneous heart pump implanted in the patient’s leg and deployed through the venous system to access the heart; however, the RP device is for use on the right side of the heart, while the original Impella is indicated only for use on the left side.
Historically, there has never been a great option for patients with right ventricular failure; several surgeons that we have spoken with have actually opted to implant an HVAD (a much more expensive device) in these patients. The doctors that we speak with—even those who are somewhat opposed to the left-side device—are actively seeking an option for their patients with right ventricular failure. While it is difficult to get a good handle on the market size in Europe, we believe it will likely represent tens of millions of dollars in incremental revenue over a multiyear period.
As far as movement into the United States, the company recently announced the completion of enrollment in its U.S. IDE RECOVER RIGHT trial and is pursuing a humanitarian device exemption (HDE) approval. Despite the sizable demand that we believe exists domestically, the product will initially be limited by HDE guidelines in the United States (although it will still be an $80 million annual opportunity, by our estimates).
Beyond the U.S. approval of RP, there are a couple of other catalysts on the horizon: left-side approval in Japan and further progress with Symphony. Approval in Japan should come at some point this summer, although reimbursement tends to be a six- to nine-month process that will likely weigh on uptake initially. Symphony is a more long-term initiative, but we continue to believe that this product is underappreciated by investors.