Abiomed Adds Cardiogenic Shock to Approved IndicationsAbiomed Adds Cardiogenic Shock to Approved Indications

Abiomed announced Thursday that many of the devices in its Impella product line had received FDA approval for use in cardiogenic shock patients. This approval comes just over a year after FDA okayed the use of Impella technology for patients undergoing high-risk percutaneous coronary intervention (PCI) procedures.

Cardiogenic shock, when the heart can't perform its pumping and perfusion duties, is usually seen in patients who have suffered a heart attack, acute myocardial infarction (AMI), or undergone surgery for a cardiopulmonary bypass. It can increase a patient's chances of death.

The approval extends to the Impella 2.5, Impella 5.0, Impella CP, and Impella LD catheter heart pumps, all used to support the left ventricle of the heart. The Impella products are percutaneous ventricular support devices that are placed temporarily. This FDA approval covers use of less than four days for the Impella 2.5 and Impella CP and less than six days for the Impella 5.0 and Impella LD, though clinicians can choose to use the device longer. The indication covers Impella use for ongoing cardiogenic shock within 48 hours after AMI or open heart surgery due to isolated left ventricular failure that isn't helped by standard treatment. 

"This approval sets a new standard for the entire cardiovascular community as clinicians continue to seek education and new approaches to effectively treat severely ill cardiac patients with limited options and high mortality risk," said William O'Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital, in a press release. "The Impella heart pumps offer the ability to provide percutaneous hemodynamic stability to high-risk patients in need of rapid and effective treatment by unloading the heart, perfusing the end organs and ultimately, allowing for the opportunity to recover native heart function."

According to commentary on Abiomed's February earnings call, the company had submitted a PMA supplement for cardiogenic shock to FDA in August 2015. Although approval was initially expected in August 2016, president, chairman, and CEO Michael Minogue expressed confidence at that time in an earlier approval. "We would like to note today that based on our current interaction with the FDA, the emergent PMA supplement approval could come ahead of our original August 2016 timeline," Minogue said, according to a Seeking Alpha transcript of the call.

In a research note following the February earnings call, BTIG analyst Sean Lavin wrote, "a shock label should increase marketing and use in emergent settings, while early DTC marketing should lead patients to cardiologists who use Impella . . ."

While the Impella products have been available for years, Abiomed was required in recent years to follow the PMA process because of FDA's 515 Program Initiative. The devices were originally "grandfathered" as Class III devices through the less-stringent 510(k) process but the 515 Initiative required these grandfathered devices to be either moved to less rigorous Class I or II designations or be reconfirmed as Class III devices and attain PMA approval.

The company submitted a large amount of data on cardiogenic shock patients, including a 415-patient analysis from a study and registry, a literature review, and a safety assessment of more than 24,000 patients in FDA's medical device reporting database, among other analyses.

FDA approval allows Abiomed to educate physicians and patients about the cardiogenic shock application.

"Today, Abiomed only treats around 5% of this AMI cardiogenic shock patient population, which suffers one of the highest mortality risks of any patient in the heart hospital," Minogue said in the release. "Tomorrow, Abiomed will be able to educate and directly partner with our customers and establish appropriate protocols to improve the patient outcomes focused on native heart recovery."

[Image courtesy of ABIOMED]