Atrium Medical Corporation and three other affiliated Maquet companies have reached an agreement concerning a Consent Decree (Decree) with the U.S. Food and Drug Administration (FDA). This voluntary agreement has been approved by a federal judge in New Hampshire and establishes a framework that provides assurances to FDA that the company will complete the improvements currently underway to strengthen its quality management system.

The Decree provides a clear path forward for the company to complete the enhancement of its quality management system and to continue to provide products of the highest medical quality.

There has been no indication that any of the products are unsafe. The consent decree does not require Atrium or Maquet to remove, recall or perform corrective actions on any products currently in the market or at any of our distribution facilities.

• Manufactuing of certain products at Atrium’s facilities in Hudson, New Hampshire has been temporarily suspended while corrections are being made. These products will become temporarily unavailable, once existing inventory located at our distribution facilities has been exhausted.

   

  • Temporarily unavailable products include select vascular grafts that had been manufactured at Atrium’s facilities in Hudson, NH. Surgical mesh production has resumed at Maquet's new Merrimack facility. Vascular graft production is anticipated to resume in the third quarter 2015.
    Restrictions do not apply to vascular grafts that are manufactured at other facilities and sold under the brand names of Hemashield, Intergard, Fusion and Exxcel Soft.
• In addition, Atrium has long planned to move manufacturing operations from Hudson, NH, to the now operational new facility in Merrimack, NH. Once production of all affected product lines is transferred to Merrimack, these products will again be available to customers inside and outside the United States. As of the second quarter of 2015, mesh is now being produced at the Merrimack facility. Vascular graft production is expected to resume in the third quarter of 2015.

• Certain products currently manufactured at Atrium’s Hudson facilities have been deemed medically necessary under the Decree and will continue to be made available to customers inside and outside of the U.S., provided that an authorized representative of the customer signs a Certificate of Medical Necessity form.

   

  • Products available under a Certificate of Medical Necessity include: chest drains, local therapeutic infusion catheters, and covered stents.
• Operations at three Maquet locations that also fall under the decree – Wayne, New Jersey and Rastatt and Hechingen, Germany – will be subject to additional inspections, but will continue to produce and distribute products globally.

• All other Maquet locations and companies inside and outside of the U.S. are not part of this Decree.

About Atrium and Maquet

Atrium, part of Maquet, specializes in manufacturing medical devices for the treatment of coronary and vascular disease, tracheal bronchial management, chest trauma, hernia and soft tissue injury.

Maquet offers innovative therapy solutions and infrastructure capabilities for high-acuity areas within the hospital — including the operating room (OR), hybrid OR/cath lab, and intensive care unit (ICU) — as well as intra- and inter-hospital patient transport. Additionally, Maquet develops intelligent and sustainable room concepts that exceed the expectations of modern hospitals, working in close cooperation with customers, production engineers and architects to integrate high quality products and services.

Headquartered in Rastatt, Germany, Maquet is the largest subsidiary of the publicly listed GETINGE Group AB of Sweden. Maquet has 6,550 employees and provides 40 international sales and service organizations, as well as a network of more than 300 sales partners.

For more information about Maquet, please visit www.maquet.com.

About Getinge Group

Getinge Group is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We operate under the three brands of ArjoHuntleigh, Getinge and Maquet. ArjoHuntleigh focuses on patient mobility and wound management solutions. Getinge provides solutions for infection control within healthcare and contamination prevention within life sciences. Maquet specializes in solutions, therapies and products for surgical interventions, interventional cardiology and intensive care.

For more information about Getinge Group, please visit www.getingegroup.com.