FDA Grants Premarket Approval To AbioMed Heart Pump Reply

The FDA said today that it had approved Abiomed’s Impella 2.5 System. According to the company it is is the first hemodynamic support device to gain FDA premarket approval for use during high risk PCI procedures.

The miniature blood pump is designed for temporary use in patients with severe symptomatic coronary artery disease and diminished (but stable) heart function who are undergoing high risk PCI but who are not candidates for surgical revascularization.

Click here to read the full post on Forbes.


FDA Approves New Heart Pump From Abiomed Reply

Abiomed has announced that it received FDA approval for its Impella RP System, the first percutaneous single access heart pump that provides support to the right side of the heart. The approval, under a Humanitarian Device Exemption (HDE), is based on results of the single arm Recover Right study, in which 30 patients were enrolled. The overall survival rate was 73% at 30 days.

Click here to read the full post on Forbes.



Buried Clinical Trial Data: The Dam Is About to Burst Reply

Two important new developments may mean that many more researchers will soon be able to access and analyze data from many more clinical trials.

… a preliminary report from the prestigious Institute of Medicine lends strong support to the open data movement. The IOM report states that investigators should be required to establish a data-sharing plan at the same time the trial is registered. The report includes detailed recommendations for when and how the data should be made available. Among the major recommendations: data underlying a trial analysis should be made available within 6 months after journal publication, and all data should be made available no later than 18 months after the last patient visit in the trial.

… the Yale University Open Data Access (YODA) Project announced that Johnson & Johnson is expanding its plans to share data.

Click here to read the full post on Forbes.


DOJ Investigating Abiomed For Improper Marketing Of Impella Circulatory Support System Reply

Cardiovascular device maker Abiomed announced that the US Attorney’s Office was investigating the company’s marketing and labeling of the Impella 2.5 circulatory support device. The announcement confirmed rumors that had been circulating for at least two weeks, though in the press release the company said it had been informed of the investigation on October 26. (I first heard the rumor on October 18.) No details were disclosed about the investigation.

The company also said that it believed that the FDA would begin a review to possibly reclassify its Impella devices as Class III devices, which would require FDA clearance using the more stringent premarket approval (PMA) process instead of the current, less demanding 510(k) premarket notification process. Whether because of the DOJ investigation or the FDA announcement, the stock price of Abiomed dropped 25% with the news.

This is not the first time Abiomed has run into trouble with the FDA. In June 2011 Abiomed received a warning letter from the FDA about improper marketing of Impella for unapproved indications.

As previously reported here, in December 2010 the company issued a press release announcing– and spinning– the results of the PROTECT II trial comparing Impella to the intra-aortic balloon (IAB) in high risk PCI patients. Although the trial was stopped early for futility, the press release downplayed the negative findings and instead emphasized positive trends and encouraging subgroup analyses. Last month, when the trial was finally published in Circulation, the company issued a much more restrained press release, perhaps a reflection of the company’s efforts to avoid further problems with the FDA.

Here are the relevant paragraphs from Abiomed’s press release today:
Click to continue reading…

News Flash! Company Issues Incredibly Boring Press Release 1

Last week Abiomed issued a press release (reprinted below) that was about as dull as a press release can get. The main news of the press release was that the PROTECT II study testing the company’s Impella 2.5  circulatory support device had been published online in Circulation.

The press release provides no details or information about the trial and makes no claims about the clinical benefits of the company’s device. The only remotely interesting items in the press release are  generic quotes from the principal investigator of the trial, William O’Neill, and from Michael Minogue, the chairman and CEO of Abiomed:

O’Neill: “Today marks a very significant milestone in providing new clinical insight for cardiovascular disease patients considered too risky for conventional surgery. The PROTECT II publication in Circulation underscores the importance of this study’s observations to the clinical community.”

Minogue: “PROTECT II is a landmark clinical trial and we are grateful to Dr. O’Neill and his colleagues for leading this study. The peer-reviewed publication of PROTECT II in the esteemed Circulation journal is a notable achievement for Abiomed. Most importantly, we believe that this study will advance the treatment for patients with heart failure.”

Now all this would be entirely unremarkable, except for the fact that O’Neill and Abiomed struck a very different tone earlier in the history of this trial.

In November 2010, when the trial was terminated early due to futility, the company issued a press release which contained numerous details about the results of the trial and then portrayed these results as a triumph, despite the fact that the overall trial was negative. Although the full results had not been publicly presented, much less undergone peer review or scrutiny from other physicians or regulators, the CEO said the trial would “pave the way to change the standard of care for PCI requiring prophylactic hemodynamic support.” And O’Neill told Wall Street investors that the trial was “a landmark trial that will impact practice.”

As I wrote then, the press release struck me as a perfect example of how to spin a negative result, relying on cherry picked endpoints and subgroups. (The original press release was removed from the company website but can be found in my news story.) Rick Lange and David Hillis provided their own critical perspective of the trial on CardioExchange.

The initial press release wasn’t the only problem with the rollout of PROTECT II. An additional issue became fully apparent a few months later in April 2011 when the full trial results were trial were scheduled for presentation at the American College of Cardiology meeting in New Orleans. Prior to the meeting the company issued a press release announcing that the study would be presented at a late-breaking clinical trials session, a highly prestigious and much-desired position.

But PROTECT II was not presented at a late-breaking clinical trial session. As I reported shortly before the ACC meeting,  the trial “was resoundingly shot down as an ACC late-breaking clinical trial at the selection meeting” because the company had violated the Ingelfinger Rule, which prevents publication of trial information that has been previously submitted or reported elsewhere. In other words, the earlier Abiomed press release led the ACC to disqualify the trial for presentation as a prestigious late-breaker.

Circulation is unlikely to lift the veil on its editorial process, but my guess is that the journal played a big role in the final shape of last week’s remarkably modest publication and accompanying press release. The Circulation paper concludes– properly– that “Impella 2.5 did not result in a superior outcome of the primary endpoint at 30 days.” The paper also reports the results of a more promising secondary analysis suggesting a possible benefit for the device at 90 days, but rather than hyping these results as heralding a change in the standard of care, the authors write: “Since the difference in 30 day MAE [major adverse events] did not reach statistical significance for the entire study, the analysis of 90 day events remains exploratory.”

So let’s celebrate genuine progress, in this case represented by a dull scientific paper and an even duller press release.

Click here to read the Abiomed press release from last week…