Abiomed ($ABMD) revealed in an SEC filing that the FDA has agreed to forgo an advisory panel meeting to discuss an expanded indication for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps, meaning permission to use the devices on emergency patients suffering from cardiogenic shock is a near certainty, and should occur before the previously expected date of August 2016.
The news means the devices are on the verge of formal entrance into a 100,000-patient market, among whom it currently has only a 5% penetration rate. During cardiogenic shock the heart cannot pump enough blood to meet the body's needs; the condition can occur after a severe heart attack or cardiac surgery.
Leerink analysts Danielle Antalffy and Puneet Souda expect a 20% growth in Impella utilization in FY2014, "which could prove conservative if the impending cardiogenic shock approval drives a similar uptick to the estimated 40%+ growth in utilization we saw in the first 4 quarters post a protected percutaneous coronary intervention (PCI) PMA approval in late CY2014."
"With a PMA approval for its suite of products in cardiogenic shock, ABMD will now be able to aggressively market to and train physicians and nurses using its extensive supportive clinical dataset--the most comprehensive ever in this indication. While cardiogenic shock represents just over 40% of Impella sales today under the 510k, this is without the company actively marketing and/or training for this indication. Cardiogenic shock represents a ~100,000-patient market opportunity, of which Impella is only ~5% penetrated today. And these are patients who are already in the hospital and require some form of temporary circulatory support. Upon approval, Impella will be the only temporary circulatory support device--vs. intra-aortic balloon pumps and ECMO--with 'safe and effective' on the label, something we believe will drive accelerating adoption and utilization," they wrote in an analyst note.
Abiomed said data submitted to the FDA in support of the expanded indication included an analysis of more than 415 patients, a literature review of 17 studies and a safety analysis of more than 24,000 patients using the FDA medical device reporting database. The company described the submission as the "most comprehensive review ever submitted to the FDA for circulatory support in the cardiogenic shock population."
Abiomed's flagship Impella franchise consists of 5 devices that provide temporary circulatory support, often during procedures like percutaneous coronary intervention (or stent implantation).
The fast-growing company saw its stock nearly triple in 2015, in spite of a 30% plunge in October when investors became jittery about the sustainability of its revenue increases.
The impending Impella indication expansion will help the company maintain its impressive growth rate and fend off competition from St. Jude Medical's ($STJ) CE-marked HeartMate PHP, which it inherited from the recently completed takeover of Thoratec for $3.4 billion.
- read the SEC filing