Abiomed shares fall on FDA warning

Abiomed

Shares of Abiomed Inc. (NSDQ:ABMD) slipped nearly five percent on Wall Street this morning, after the FDA posted a warning letter admonishing the heart pump maker for marketing a device for uses it’s not cleared for.

The federal watchdog agency said a May 12 review of Danvers, Mass.-based Abiomed’s advertising, product labels and website “indicate that Abiomed is making claims that we stated were inappropriate in a January 28, 2010, letter to your firm” about its Impella Recover LP 2.5 cardiac assist device.

“These claims represent a major modification to both the intended use and the indications for use of the device,” according to the missive.

Abiomed spokeswoman Aimee Maillet told MassDevice that the FDA’s letter addresses promotional materials the company used last year and has since dropped.

“We are working with the FDA to address the issues, but have since ceased the specific promotional items from 2010,” Maillet wrote in an email. “We are working with the FDA to ensure all of our promotional materials comply with the agency moving forward.”

Abiomed won 510(k) clearance for the device, which is inserted via catheter into the heart to help it function, “for ‘partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella Recover LP 2.5 also provides pressure measurements which are useful in determining intravascular pressure,'” according to the FDA.

But the company touted the device for uses outside that clearance, specifically for comparing the Impella to treatment with an intra-aortic balloon pump, which the agency said it warned Abiomed not to do in the January letter.

The FDA also chastised the company for claiming that the device helps improve hemodynamics and cardiac output in heart attack patients, thereby reducing mortality rates.

“Both of these indications would need to be supported with an appropriately designed clinical study performed under an Investigational Device Exemption,” the agency wrote.

And a tagline found on the Abiomed website and in a print ad, “Recovering Hearts, Saving Lives,” amounts to “another claim that would require a randomized clinical study performed under an IDE specifically to evaluate whether the device could salvage heart tissue and muscle,” according to the letter.

ABMD shares were trading at about $15.62 around noon today, down 4.9 percent.

RSS From Medical Design & Outsourcing

  • CardioGenics enters into manufacturing agreement with Ontario-based Plasticap
    CardioGenics Holdings, developer for the In-Vitro-Diagnostics (“IVD”) testing market, announced that it has entered into a manufacturing agreement with Plasticap of Ontario, Canada, pursuant to which Plasticap will manufacture CardioGenics’ proprietary self-metering cartridges for its QL Care analyzer. The term of the agreement is three years and the purchase price for each cartridge shall be […]
  • MTD Micro Molding releases micro materials menu
    MTD Micro Molding, a long-time leader in micro-injection molding, has released an updated “Materials Menu” of materials that can be successfully micromolded to help guide engineers at medical device companies. Material selection is a crucial step in product manufacturability. The correct material drives tolerance, dimension, strength, usabality, speed-to-market, design, critical features, and cost. Through MTD’s […]
  • MedTech Chat: Elastic technology for drug delivery
    Dr. Zhen Gu and Dr. Yong Zhu from North Carolina State University are both co-senior authors of a research paper describing their recent work. Dr. Gu, Dr. Zhu and other researchers from North Carolina State University and the University of North Carolina at Chapel Hill have developed a drug delivery technology that consists of an […]
  • B. Braun’s OEM Division offers large bore normally closed low-pressure check valves
    Infusion therapy and pain management device manufacturer B. Braun said today it is offering normally closed large-bore low-pressure check valves through its valve-focused contract manufacturing OEM division. The valves, offered by Bethlehem, Pa.-based B. Braun, are designed for the intermittent injection of fluids during medical treatment and open automatically when pressure is applied. The newly […]
  • Continuous 225W with natural convection for medical type BF power supply
    Powerbox, a European power supply company, introduces new Medline 225 series ac and dc single output open frame converters for medical type BF applications. The new OFM225 with its 3 x 5 in. footprint and 1.5 in. height is designed for a continuous output power of 225W with natural convection and 40°C ambient temperature, increasing to […]
  • Using data science to achieve ultra-low dose CT image reconstruction
    Prof. Jeff Fessler and Prof. Yong Long, Ph.D. of the University of Michigan-Shanghai Jiao Tong University (UM-SJTU) Joint Institute are collaborating on a project to develop a dramatically improved approach to low-dose X-ray CT image formation by extracting and using information from a big-data corpus of regular dose X-Ray Computed Tomography (CT) images. The research is […]
  • New vented dust caps from Qosina prevent damage and contamination on a new level
    Qosina is pleased to announce the addition of eleven new soft TPE vented dust caps (#11300, #11301, #11320, #11330, #11331, #11340, #11341, #11350, #11360, #11361 and #11380) in stock and ready for immediate delivery. These components are available in a variety of colors including blue, green, red, white and yellow; sizes range from 0.187 in. […]
  • Nader Najafi: A dream that saves lives
    Miniature wireless sensing and computing devices have the potential to improve people’s health, even save lives. Twenty years ago, working on microelectromechanical systems (MEMS) as a student at Michigan, Dr. Nader Najafi had a dream to be part of this future reality. He turned that dream to action when he left a promising career at […]
  • PBC Linear’s guide for approved bearing inspection method
    Understanding the method to properly inspect the Frelon liner in PBC Linear’s Simplicity plain bearings is essential to taking full advantage of the product. The Frelon liner supplies numerous attributes that make it preferable in many unique applications; however, being a teflon-based material requires a different method of inspection: Approved Inspection Method: Pin Gauges (AKA: Go or […]
  • 3W to 10W DIP-24 DC-DC converters have medical certification
    TDK announces the introduction of the TDK-Lambda PXC-M series of DC-DC converters. Operating over a 4:1 input range, the 3W, 6W and 10W products are enclosed in the industry standard 1.25 x 0.8 x 0.4 in. DIP-24 package. Applications include a wide variety of medical applications and battery powered equipment. With a 5,000 Vac input […]
  • How do you mend a broken heart? By converting fat cells into stem cells that can help that vital organ repair itself
    Editor’s Note: This article is written by Jeannie Kever and discusses the recent research from the University of Houston. There has been little time to savor the successes of the moment as Dr. Robert Schwartz and members of his lab push relentlessly toward their goal. Their goal is to begin clinical trials that will showcase how common fat cells, treated […]

Leave a Reply