FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal

The warning letter is the latest indication of the fresh scrutiny the FDA is paying to software tools and decision aids.

FDA Scolds Abiomed for Not Seeking a PMA for Its Web-Based User Portal

The US Food and Drug Administration has sent a warning letter to Abiomed, saying the cardiovascular device manufacturer should have obtained premarket approval (PMA) for its Impella Connect system before making the software available to users. Specifically, the agency says in the letter made public on the FDA’s Compliance Actions and Activities portal last week, the technology is a device and should have been cleared as such through regulatory processes.

The warning letter, sent to Abiomed September 19, 2023, is the latest in a long line of exchanges sparked by FDA inspections earlier this year. It comes at a time when the agency is cracking down on clinical decision support software, novel tools that are being increasingly used in healthcare settings. Back in May, iRhythm Technologies faced similar scrutiny, receiving its own notice of violations.

The FDA’s letter to Andrew Greenfield, Abiomed’s president since 2022, uses the same stern language: “Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”

Johnson & Johnson acquired Abiomed for $16.6 billion last year.

As described by the FDA, Impella Connect “comprises a web-based user portal (software) and a remote link module (hardware) that are designed to work with the Automated Impella Controller (AIC), which is part of a medical device system that provides temporary ventricular support to help a patient’s heart to pump blood in a critical care setting. The Impella Connect system allows users to remotely monitor the performance of an individual AIC pump or multiple pumps and view case information on demand, as well as to filter notifications by alarm status.”

Now, Abiomed will have to go through the formal steps of seeking a PMA for Impella Connect, as the FDA’s letter gravely spells out. “The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.”

In response to the FDA’s rebuke, Abiomed issued a statement saying, “We are working closely with the FDA to fully resolve the observations as quickly as possible. As we continue to integrate into Johnson & Johnson MedTech, we are implementing quality system process improvements related to the observations, and many of these corrective actions are already in process.”

The company pointed out to TCTMD that the letter mainly references “certain functionalities of the Impella Connect app,” noting that “guidelines surrounding software device functions are evolving,” and reiterated Abiomed’s commitment to work with the FDA. “The Impella Connect app does not affect the function of the pump, and our Impella heart pumps remain on the market and available for patients,” the statement says.

Also cited in the FDA letter are manufacturing issues that have been the subject of Corrective and Preventive Actions dating back to 2020. These relate to sidearm damage, purge system leaks, luer leaks, and pump stops with the Impella 5.5 percutaneous left ventricular assist device. Other incidents include a “burr” found on the Impella CP and software bugs.

The FDA asserts that Abiomed has failed to properly follow procedures for addressing the problems, and more broadly, that the company doesn’t have the right processes in place to evaluate and report complaints.

In June 2023, as reported by TCTMD, Abiomed recalled the labeling for catheters used in its Impella RP Flex with SmartAssist System and issued a “device correction” for all types of its Impella left-sided mechanical circulatory support devices because the pumps’ labeling didn’t fully address the precautions needed when treating patients who have undergone TAVI. In April 2023, Abiomed recalled some of its Impella 5.5 with SmartAssist devices in response to complaints about purge fluid leaking from the purge sidearm of the pump. All three were designated a Class I recall by the FDA.