Abiomed CEO Minogue on DoJ probe, FDA call

Abiomed

Cardiologists aren’t paying much attention to the noise around Abiomed (NSDQ:ABMD) and its flagship medical device, the Impella heart pump, at least according to chairman, president & CEO Michael Minogue.

That noise centered around a pair of events during the 4th quarter: news of a U.S. Justice Dept. probe into its marketing of the Impella pump and an FDA decision to require the device to undergo a more rigorous approval process.

The Danvers, Mass.-based medical device company revealed the DoJ probe last year, sending share prices down more than 30% in a day. A month later a federal watchdog agency panel voted to require that the Impella undergo the FDA’s pre-market approval protocol, which ordinarily requires extensive clinical trials before approval is granted.

Minogue downplayed the effect on Abiomed’s cardiologist customers after he was asked during a conference call with investors about all the "noise" surrounding the 1-2 punch.

"I think that there definitely was noise. For the most part, our average user and physician is not tied into that noise. Certainly some folks may hear about it and track more of the information," Minogue said. "The most important factor to customers, again, is just improving patient outcomes, so I think in their grand scheme they are really, again, focused on using the technology, because they believe it’s the right thing for their patients."

The DoJ investigation has prompted at least 3 lawsuits against Abiomed, a pair of purported class actions and a shareholder derivative suit, all alleging that the company and its management deliberately concealed allegedly illegal marketing practices for the Impella 2.5 device that led to the probe.

As for the FDA’s decision, Minogue said the agency has yet to consider "the totality of the data" behind the Impella pump.

"Since the December panel meeting, we have had multiple conversations with the FDA and have recently submitted an extensive briefing document, outlining the totality of the Impella data to demonstrate safety and effectiveness," he said. "The summary includes 262 patients under [an] FDA IDE-approved protocol, 685 patients that meet the FDA clinical evidence requirements, including the Impella registry, and also references 201 publications, covering 1,877 patients.

"It is important to note this library of clinical evidence required 7 years of studies and a $30 million investment by Abiomed. Additionally, with over 12,000 U.S. patients supported to date, Impella maintains a low adverse event rate relative to the MDR rate listed by the FDA," Minogue said. "From a hemodynamic perspective, there is extensive clinical literature demonstrating that Impella provides significantly more hemodynamic support than the [intra-aortic balloon pump]. Since the 510(k) clearance in 2008, Impella has become the most widely-used heart pump in the United States. We have been encouraged by the FDA to submit a formal PMA and we hope to gain additional clarity as to the agency’s expectations for the submission after our meeting with them later this quarter."

ABMD shares closed down today after the company reported a profit decline for its fiscal 3rd quarter. Shares ended at $13.54, down 6.0% on the day.

RSS From Medical Design & Outsourcing

  • Athermal laser machining cuts bioabsorbable polymers and more
    A the recent MD&M East trade show in New York, Norman Noble, discussed the capability of athermal laser manufacturer. The company has developed the Noble S.T.E.A.L.T.H. (System To Enable Ablation Laser Technology Haz-free). The athermal laser machining process was developed to create precise features in any material, including bioabsorbable polymers, shape memory metals and other […]
  • Exciting possibilities for metallic glass in the medical device world
    Researchers are exploring the potential of metallic glass as a versatile, pliable material that is stronger than steel, with a bevy of possible medical device applications. Yale University engineers have discovered a unique method for designing metallic glass nanostructures across a wide range of chemicals, a technique that could have applications for everything from watch […]
  • Strong Precision Technologies’ medical divisions to unify under MedTorque brand
    Strong Precision Technologies announced on July 2, 2015, that its two medical divisions will now go to market under a single brand, MedTorque. The move reflects the increasing integration of the division formerly known as Inland Midwest with MedTorque, its sister division in Kenosha, WI. “We will continue providing our customers with the personalized level of service […]
  • Olympus offers next-day product replacement guarantee for medical devices
    Olympus, a medical and surgical procedures solutions company, announced that it is guaranteeing next-day replacements for surgical equipment at no additional charge. Olympus is the first surgical product manufacturer to offer this type of guarantee. The service became available to customers with an Olympus Full Service Agreement earlier this year. “Canceled procedures can be costly for healthcare facilities […]
  • More accurate prediction on prognosis in multiple myeloma from SkylineDx
    SkylineDx, a biotechnology company specializing in the development and commercialization of genetic tests, is launching its MMprofiler assay. This test enables clinicians to more accurately predict the prognosis of patients with multiple myeloma (bone marrow cancer) than traditional methods. The MMprofiler measures the activity of 92 genes which are directly or indirectly related to the […]
  • Flint Mobile swaps card reader for camera, accept mobile payments anywhere
    Flint Mobile, the swipe-free mobile payments app, has significantly expanded its payment management and loyalty capabilities for small, service-centric businesses, like the ones run by on-the-go medical equipment professionals. The toggle-free mobile technology makes the process quite simple for both parties, as all transactions are conducted through the mobile device’s camera without the need of any external […]
  • Should scientists be allowed to genetically alter human embryos?
    Scientists have at their disposal, a way to explore the possible prevention of genetic diseases before birth. But should they? Currently, the most promising path forward involves editing the genes of human embryos, a procedure threaded with controversy. An article in “Chemical & Engineering News” (C&EN), the weekly newsmagazine of the American Chemical Society (ACS), parses […]
  • Tackling chronic sinusitis by addressing underlying factors
    The stuffy noses and sinus pressure of head colds are uncomfortable, but for most people, they go away within days. For those with chronic sinusitis, however, those symptoms and others drag on for weeks. Now scientists are onto a potential new therapy that could address one of the underlying factors associated with the condition. They […]
  • Implantable “artificial pancreas” could help diabetes patients control their blood sugar
    Living with Type 1 diabetes requires constant monitoring of blood sugar levels and injecting insulin daily. Now scientists are reporting in the American Chemical Society (ACS) journal, “Industrial & Engineering Chemistry Research,” the development of an implantable “artificial pancreas” that continuously measures a person’s blood sugar or glucose level and can automatically release insulin as […]
  • Drug Deactivation program roll out to all facilities for safe disposal of unused prescription medications
    Verde Technologies announced that New Brighton-based Meridian Behavioral Health, the largest for-profit substance abuse and addiction treatment group in Minnesota, has become its most recent partner in the deactivation and safe disposal of prescription medications including methadone. Meridian is the first behavioral health group to roll out the Deterra Drug Deactivation System to all 17 […]
  • Lophius Biosciences introduces T-activated ImmunoScan Cocktail
    Lophius Biosciences announced the commercial launch of T-Track ImmunoScan and T-activated ImmunoScan Cocktail. Based on a proprietary and very specific cocktail of stimulants in combination with the Company’s T-activation technology, T-Track ImmunoScan and T-activated ImmunoScan Cocktail specifically target different cell types involved in both the adaptive and innate immune system. T-Track ImmunoScan and the T-activated […]

Leave a Reply