Abiomed claims Impella pump not at fault in patient death

Update: Includes statement from Abiomed

After reporting possible issues with two of its Impella heart pumps used in an open heart surgery, Abiomed (NSDQ:ABMD) said today that the devices were not to blame for the patient’s death.

The Impella devices were used in a last-attempt effort to save an elderly patient undergoing open heart surgery, Abiomed CEO Mike Minogue said in a statement sent to MassDevice.com

“This was a very sick elderly patient who had poor heart function. The patient was having trouble coming off a heart and lung machine during open heart surgery. Impella was used as a last resort to try to save the patient,” Minogue wrote in the statement. “We closely track our cases, reviewed this case when it happened, and it was determined Impella was not related to the outcome.”

The first pump detected a clot in the patient’s blood stream and stopped functioning to prevent the clot from entering the patient’s brain, Minogue said in the statement, while the second pump was likely bent during the insertion process.

“We’re saddened to hear of any patient’s death from heart disease, and this only increases our commitment to our mission of recovering hearts and saving lives,” Minogue wrote in the statement.

The Danvers, Mass.-based company initially reported issues with two Impella pumps in a posting to the federal watchdog’s Medsun database last month.

The issues were investigated by engineers who found material in the first pump that reduced flow, and that the pump housing/outlet cage and impeller were crushed in the second.

Last month, Abiomed joined a $7 million financing round for RenalGuard Solutions.

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Abiomed shares rise on Street-beating Q4, FY2018 earnings

Shares in Abiomed (NSDQ:ABMD) are rising today after the medical device maker beat expectations on Wall Street and saw massive growth to its profits in its fourth quarter and full fiscal year 2018 earnings results.

The Danvers, Mass.-based posted profits of $36.9 million, or 80¢ per share, on sales of $174.4 million for the three months ended March 31, seeing bottom-line growth of 147.3% while sales grew 39.9% compared to the same period during the previous year.

Earnings per share for the fourth quarter were well ahead of the 64¢ consensus on Wall Street, where analysts expected to see sales of $164.3 million.

For the full year, Abiomed posted profits of $112.2 million, or $2.45 per share, on sales of $593.8 million, seeing the bottom-line grow a massive 115.2% while sales grew 33.3% compared with the pervious fiscal year.

Earnings per share were ahead of the $2.30 consensus on Wall Street, where analysts expected to see sales of $583.7 million, which the company also topped.

“Abiomed delivered another record quarter and fiscal year. I am proud of our Patients First execution and operational discipline from research to manufacturing to customer support. We earned multiple global regulatory approvals in the US, Germany and Japan on new products, new indications and reimbursement. Fiscal 2019 is positioned to be another outstanding year and we appreciate the investment from our shareholders. I am also grateful to the dedicated employees and customers that have enabled us to serve our patients and achieve our corporate goals around heart recovery,” prez & CEO Michael Minogue said in a prepared statement.

Abiomed provided guidance for its fiscal year 2019, expecting to see sales of between $740 and $770 million, up 25% to 30% over 2018.

Abiomed shares have risen 11.2% so far today, at $335.95 as of 11:19 a.m. EDT.

Last month, Abiomed saw shares fall slightly after the Centers for Medicare and Medicaid Services released a proposal covering changes in its reimbursement.

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Unsealed Abiomed whistleblower suit reveals claims of retaliation

Newly unsealed court documents related to an alleged kickback scheme that Abiomed (NSDQ:ABMD) agreed to settle last week for $3 million revealed claims of retaliation against the whistleblower in the case.

The plaintiff-relator in the case, Max Bennett, accused the Danvers, Mass.-based company of firing him in retaliation for speaking out on the allegations that the company wined and dined physicians to encourage them to use its Impella heart pump, according to court documents.

“Shortly after Relator raised questions about Abiomed’s non-compliance with federal law, Abiomed’s management questioned Relator regarding his prior employment with Biotronik Inc. (a pacemaker company) and the reasons why he had left. During the course of these discussions, it became obvious to Relator that Abiomed’s superiors believed that he had been a whistleblower at his previous company, and therefore assumed that he would blow the whistle against Abiomed. Abiomed then retaliated against Relator by firing him on November 14, 2012, in violation of both federal and Massachusetts law,” unsealed court documents read.

Last week, federal prosecutors said that Abiomed agreed to pay $3 million to settle the case.

The U.S. Justice Dept. said that Danvers-based Abiomed agreed to settle the allegations for $3.1 million after a whistleblower’s lawsuit accused the company of buying meals for doctors “at some of the country’s most expensive restaurants, including Menton in Boston, Nobu in Los Angeles, Spago in Beverly Hills, and Eleven Madison Park in New York City.”

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Medical device companies: These 15 performed the best in 2017

[Image from Unsplash]

Updated Jan. 5, 2018

Among the most successful medical device companies of 2017, there were two themes: innovation and breadth of services.

That was the major takeaway of an MDO analysis of the stock performance of the 100 largest publicly traded medtech companies in the world.

What does innovation mean? Think Align Technologies (Nasdaq:ALGN) and how it brought 3D printing to bear on a dental product screaming for better customization: braces. Or there’s Abiomed (Nasdaq:ABMD) and its tiny Impella heart pump, which is meant to help restore blood flow and allow the heart to rest after a heart attack.

For breadth of services, look no farther than Integer (NYSE: ITGR). Created out of the 2015 merger of Greatbatch and Lake Region Medical, Integer is a giant medical device contract manufacturer that could theoretically do almost anything for an OEM.

Most – about four-fifths – of the world’s 100 largest medical device companies saw their stock price increase this year. But Align, Abiomed, Integer and other top companies enjoyed an especially exceptional performance.

Here are the 15 best-performing medical device stocks of 2017, ranked by their stock growth percentage.


And click here to download a performance spreadsheet of the 100 stocks>>

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Maquet opens a new front in patent war with Abiomed


Abiomed, MaquetGetinge (PINK:GETI B) subsidiary Maquet opened a new front last week in its patent war with Abiomed (NSDQ:ABMD), alleging infringement of a patent granted earlier this year.

Danvers, Mass.-based Abiomed sued Maquet in May 2016, asking Judge Dennis Saylor of the U.S. District Court for Massachusetts for a judgment of non-infringement of a trio of patents; counter-suits later brought the number of disputed patents to six.

Last week Maquet added the latest piece of intellectual property to the case, alleging that Abiomed infringes U.S. patent no. 9,597,437, covering a  “Guidable Intravascular Blood Pump and Related Methods.” Maquet alleged that Abiomed’s Impella 2.5, the Impella 5.0, and the Impella CP infringe at least two claims of the patent, which was granted March 21, according to court documents.

Abiomed asked the patent office for a quartet of inter partes reviews of the ‘437 patent, according to the documents, but the Patent Trial & Appeals Board denied two of the petitions Oct. 18.

Maquet is seeking judgments of basic, induced, contributory and willful infringement, plus preliminary and permanent injunctions barring further alleged infringement, basic and triple willfulness damages and royalties. The company also wants Saylor to force Abiomed to cover its legal costs and to grant pre- and post-judgment interest, according to a Nov. 20 court filing.